Create Synergies by Integrating Quality Management & Document Management

A manufacturing organization often needs to manage and control an intricate web of quality events, any one of which potentially generates numerous parallel or sequential actions. For example, a deviation might occur in a manufacturing process. That deviation must be tracked, investigated, and corrected as needed.

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Medical Device Excise Tax Repealed… Now What?

The controversial medical device excise tax of 2.3% that was enacted as part of the Affordable Care Act was suspended, albeit temporarily for two years. What does this tax mean to the medical device manufacturers?

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Where in the World is Mohan Ponnudurai.....India 29-30 October

This is part two of an ongoing series of posts from Mohan Ponnudurai as he attends and speaks at quality shows and conferences across the globe. Read part one here.

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Where in the World is Mohan Ponnudurai.....Germany 26-27 October #15EMS

This is part one of an ongoing series of posts from Mohan Ponnudurai as he attends and speaks at quality shows and conferences across the globe.

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Leveraging Your GMP System to be a Global GxP Solution

Pharmaceutical companies face some very real challenges within clinical quality management. There are pressures to not only to ensure compliance but to get approved drugs to market safely and effectively without spending additional funds on redundant quality management tools that may already exist in their organization. One way to address these challenges would be for pharmaceutical companies to create a global GxP solution that ensures visibility across the supply chain as well as automate quality processes, sufficient tracking of all correspondence, and more.

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Will We Finally See an Update to TSCA this Fall?

For years, various environmental and industry groups have pushed Congress to do something about regulations in the TSCA. States have acted on their own, in many cases, and have issued their own REACH-type requirements that go beyond what is currently regulated and enforced in the TSCA. 

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Recap: Sparta Connection 2015

Sparta Connection 2015, our annual user conference, was held June 8-11 in Orlando, Florida at the Swan Resort.  Over 350 attendees enjoyed featured discussions on game-changing technology and trends in quality and supplier management, mobile, cloud and business analytics.

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The Value of Quality Assurance in an Agile World

I remember the days of the waterfall approach, when we were towards the end of a release, scrambling to prioritize the test cases to execute (of course, not all test cases were automated and we only had a few weeks to complete the process).

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Best Practices for a Successful Software Upgrade

In our first blog post on the subject of upgrades, we discussed some of the barriers companies face in upgrading their enterprise applications. In addition to concerns surrounding cost – which could be persuasive on its own if there aren't any perceived issues with the software – some companies may have an extensive validation process in place.

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Preparing Your Complaints/eMDR System for Upcoming FDA Mandate

The impact of poor product quality can be far reaching for a manufacturer.  High costs from returns, scrap and reprocessing combined with lost revenue and decreased customer retention comprise the direct risks of not managing quality effectively.  The cost of poor quality is further compounded when you include costs associated with expensive field corrections and product recalls.

To manage this risk and gain better visibility of quality issues, many leading companies are leveraging the complaint management process as part of a more comprehensive approach to quality management.  Complaints are a key source of quality data and integrating the complaint process with the quality management system enables a manufacturer to quickly identify problems and issue early quality alerts when products are not meeting there desired specifications.  As a result companies can move quickly to resolve quality issues in the market thereby minimizing potential costs of poor quality such as unanticipated service labor and parts costs.  Broadly, complaint information can be analyzed for trends and severity to identify where there might be a risk of recalls or an opportunity for product design improvement.   Moreover, gaining control of complaint data and linking it to quality management practices also further enables regulatory compliance.

Reporting to the FDA

One of the top 3 most frequent warning letter citations found in 2013 included Complaint files, specifically establishing and maintaining procedures for receiving, reviewing and evaluating complaints (21 CFR 820.198(a))*.  FDA requires manufactures to report product problems and adverse events to the FDA for Medical Devices.  A complaint management system has all the information that is needed for this type of reporting and can easily be adopted to manage submission processing using FDA’s MedWatch 3500A form. 

A key benefit to the automated form is the ability to include more valuable information on reporting as well as reporting more frequently.  This increases the transparency between both parties.  But the process can only be sustainable by FDA and manufacturer if using an electronic system to process the large volume of reports coming in.  For example, a current medical device manufacturer submits 25,000 MDR files annually to FDA which includes initial reports and supplemental reports.  If you multiply that by the number of manufacturers located in the US, you can easily understand the problem that the FDA has.  They can’t have personnel opening email or paper reports and sort and file those reports in a timely manner. 

This is a major reason why the FDA is transitioning to an electronic system.  With this new system in place, FDA can now accept Medwatch forms electronically and maintain the information in a central database.  Up until now, submitting MDR forms electronically has not been required.

Preparing your Quality System for Electronic Filing

Having reliable quality processes, systems and reporting infrastructures in place will facilitate effective and timely complaint management, especially as new legislation is created to better track and report adverse events.  Effective August 14, 2015, electronic submission of MDRs will be required to the FDA.

This new way of collecting data will help with the gathering and analyzing post market MDRs while minimizing data entry errors. eMDR submissions already have strict timeframe guidelines on how quick a manufacturer is required to report the eMDR based on when they were made aware of the problem.  Each of these data elements that are captured in your complaint intake, whether it’s integrated from another quality system, a CRM on-site or direct line from the hospital or doctor’s office,  need to provide information back in so reports can be created.  As long as there is a feeder to get those complaints, data and reports can easily be generated from the complaint system.

Implementing an automated global complaints process should be part of a company’s overall business strategy in order to effectively and efficiently track and monitor complaint handling performance.  The ability for a complaint handling system to communicate with a quality management system is essential for identifying if other facilities are having issues, communicating to leadership for continuous improvement and trending to prevent additional problems from occurring in the future.


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How Can the Latest Version of Stratas Help Drug Companies Better Manage Customer Complaints and Non-conformances with Suppliers?

Stratas was developed for TrackWise as a tool for supplier quality management to prevent these serious issues from occurring. It is a customer supplier portal that is used to manage and maintain the Approved Supplier List (ASL), determine supplier risk, and track and manage supplier quality workflows.

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How TrackWise® EQMS Software Facilitates a Holistic Approach to Quality Management

When the International Organization of Standardization developed the ISO 9000 family of Standards in 1987, it aimed to improve quality management through a more systematic approach. It was developed with past methods of quality control in mind, including Total Quality Control (TQC) and Total Quality Management (TQM), but emphasized even further the importance of taking a process approach to quality management systems.

The goal of ISO 9000 is to utilize a quality management system to increase productivity, reduce costs, and ensure quality of processes to safeguard the integrity of products so they meet consumer needs. The standard specifies that procedures such as deviations, audits, change control, complaint tracking and supply chain management must be documented and followed by all levels of an organization for its effective operation. This goal is further facilitated by effective leadership, COPQ for risk management, and well organized data management. .

Over the years, the 9000 family of Standards have been revised to reflect changes in the global marketplace, but this holistic concept to quality management has remained the cornerstone of how quality management systems are judged in the 21st Century. In order for an organization to be able to achieve compliance with them, it needs a software solution that encourages holism on the enterprise level, which is why we developed TrackWise, an Enterprise Quality Management Software solution..

Here are four frequently asked questions about TrackWise and how it can help you reduce risk and keep compliant: 

Who Should Use TrackWise?

TrackWise is used by organizations in highly regulated industries that continue to face pressure to maintain the highest level of quality control in every facet of their operations. Some companies may be experiencing compliance issues, lack of transparency, increased costs or quality control problems. Others may be more forward thinking and implement TrackWise to be at the forefront of their industry.

Does TrackWise Integrate with Other Enterprise Software Systems?

Yes, TrackWise is highly configurable to meet the needs of your particular industry without painful integration complexities. Especially with today’s economic environment, with an increased number of mergers and acquisitions in many industries, a complex solutions landscape is becoming the norm. TrackWise EQMS allows for real-time interaction with enterprise software systems including Enterprise Resource Planning (ERP), Customer Relationship Management (CRM), Laboratory Information Management Systems (LIMS) and Manufacturing Execution Systems (MES). In addition, TrackWise offers the flexibility and configurability to adapt to company-specific business processes enabling organizations across a range of industries to define, track, manage and report on the core activities and processes vital to their success.

How Does TrackWise Help Organizations Comply with ISO 9001:2008 Regulations?

TrackWise integrates quality processes, automates workflows, and ensures consistency and improvement of all quality functions within an organization.  TrackWise allows companies to manage complicated business processes throughout the product lifecycle – from supply chain management manufacturing to customer service – while mitigating risk, controlling costs and gaining greater efficiency.

How Does TrackWise Support Compliance with Other Regulations and Requirements That Are Specific to My Industry?

Just as the ISO 9000 family of Standards was revised to apply to a number of different industries, TrackWise is highly configurable to meet individual needs. Customers in the pharmaceutical, medical device, consumer products, electronics, and other high-tech industries have chosen TrackWise to help them ensure the quality of their products and services and comply with unique challenges, regulatory requirements, and business objectives. 

TrackWise experts work with companies to address all aspects of system implementation and maintenance, including business requirements analysis, configuration, prototyping, testing, validation, training, go-live and ongoing support. As needs change and different regulations are introduced, the TrackWise system will continue to evolve to meet companies’ new requirements. Click here to learn more about TrackWise.  

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Can Automation Reduce the Risk of Food Recalls?

Is automation the answer to preventing the health and economic consequences that come from a food recall?

A comprehensive automated food safety management system helps eliminate the inefficiencies, risks and waste that come from a paper-based system. More importantly, it ensures compliance with the food safety standards and procedures established by recently created or amended Federal regulations, including the FDA Food Safety Modernization Act (FSMA).

However, this news hasn't reached the food industry as a whole yet, and most organizations still have a manual, paper-based system in place to evaluate and keep records of their internal audits on hazards and facility operating procedures.  This could be costly if there is an issue – both for the consumer and the organization.

Therefore, for the purposes of this blog post, we will discuss why food recalls happen, how the FSMA aims to change the way we act towards food recalls, and why automation can greatly help food organizations comply with this incredibly important food safety law.

The Consequences of a Food Recall

Health Consequences of Widespread Food-Borne Illnesses and Other Food Issues Each Year

Impact on Economy and Business

·        The annual economic cost of a recall is $77 billion[1]

·        The average cost of a food recall for an organization is $10 million[2]

·        Consumer confidence can dwindle after a reported food recall. The stock price of an organization could fall up to 22 percent within 2 weeks after the announcement.

When Is a Food Recall Triggered?

There are three classes of food recalls Class I is the most severe as use or exposure to the product could cause serious harm or even death. Class II might produce an adverse effect, but it is normally temporary or treatable – many allergens, for example. Class III is often innocuous to the public, like a minor mislabeling issue.

Some of the more common reasons for a food recall include:

·        Contamination with a pathogen ( E.coli, Salmonella, Listeria, etc.)

·        Undeclared allergen

·        Labeling Error

·        Manufacturing Error

·        Foreign Object Contamination[1]

[1] Understanding Food Recalls: The Recall Process Explained. Food Safety News. Jessica White-Cason. August 12, 2013 

[2] Recall Execution Effectiveness: Collaborative Approaches to Improving Consumer Safety and Confidence. Deloitte, FMI, GMA, GS1 US. May 2010

There are many causes for these reasons for a recall. Outdated facilities or practices, employee error, a growingly complex supply chain with many players involved, traceability concerns, and natural disasters all have been behind some of our nation's worst food recalls.

How Does the Food Safety Modernization Act Encourage Prevention Rather than Response?

Over the years, the FDA has been given greater responsibility to strengthen our food safety standards. The most significant recent legislation has been the FSMA, which was passed by Congress in 2010. The legislation shows a shift in policy in how we ensure the safety of our food. Rather than working on better response, the FDA will instead focus on getting food companies to be active participants in the prevention of food recalls.

The FSMA mandates thorough food safety hazard plans (HACCP and HARPC) that call for review of potential hazards, controls and critical points in the food manufacturing process. Food companies must be active in preventative measures against hazards and have plans in place to address any that are found. Those that don't face penalties, potential consumer backlash and other negative consequences.

In addition to that, food organizations must register their facilities every 2 years; keep records of manufacturing process, internal audits, product testing, and more for easy FDA access; and confirm compliance from their foreign exporters as an estimated 15 percent of our food supply is imported[2]. The FSMA also gives the FDA mandatory food recall authority if necessary.

How Does Automation Help Companies Comply with the Food Safety Goals of the FSMA?

With the FSMA, the end game is to have more standardized operations, better access to information, and more accountability if these food safety requirements aren't being addressed. It's for these and many other reasons why automation through a software-based QMS is so crucial to the Food and Beverage organization of today.

An automated HACCP/HARPC process that connects to a QMS provides visibility into complaints, audit findings, Corrective Actions (CAPA), change management, and supplier quality to prevent food recalls. Additionally, automation helps every part of the food supply chain system achieve its ultimate goal: providing a quality product to the consumer.

Therefore, yes, automation should be an investment food and beverage companies make in this new era of food safety.

[1] Understanding Food Recalls: The Recall Process Explained. Food Safety News. Jessica White-Cason. August 12, 2013

[2] Food Safety Legislation Key Facts. (

An automated HACCP/HARPC process that connects to a QMS provides visibility into complaints, audit findings, Corrective Actions (CAPA), change management, and supplier quality to prevent food recalls. Additionally, automation helps every part of the food supply chain system achieve its ultimate goal: providing a quality product to the consumer.

Therefore, yes, automation should be an investment food and beverage companies make in this new era of food safety.

Connect with Kelly Kuchinski on Google+.

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Preparing Your Organization for New FDA Requirements and eMDR

In February 2014, the FDA finalized its Electronic Medical Device Reporting Rule that calls for manufacturers and importers to use a very specific electronic format for event reporting to the FDA. This rule will go into effect on August 14, 2015, with two options – using eSubmitter (for low volume) or HL7 (batch or individual XML). One of the biggest challenges that manufacturers face in preparation is to gather the right data into a data management system before the rule is implemented. Until now, many manufacturers were able to just upload files manually to a database on a product by product basis. This new, more stringent rule calls for a more exact form of record keeping that looks to a specific style of formatting alongside documented checks and balances. This is to ensure that when a quality issue has been detected by a server, it is reported in a timely manner.

Different Facilities, a Common Problem

What complicates the issue is that many large companies are data-challenged. Data from a manufacturer may be in one location, while its supplier may have data sitting in another facility. Although these data sets may relate to a common product or common quality issue, they exist in different silos, formats and databases. Bringing it into a common set, even in larger companies, will prove to be a challenge.

It’s not just large manufacturers and suppliers that are isolated in terms of data. Mid-size companies that grew as a result of M&A activities acquisitions may still have data management systems in place that were used prior to acquisition. Rather than consolidate those separate databases together in a unified hub, each enterprise still has its own data set. The new eMDR rule will drive these companies to combine data together into one quality system to report accurately.

Reports must be submitted through the FDA’s Electronic Submissions Gateway (ESG). This is where an EQMS such as TrackWise can help bring separate data sets together for accurate, timely reporting that helps to keep an organization compliant with FDA medical device regulations, as well as prepared in the event of an audit.

TrackWise makes use of a submissions manager that interfaces with FDA compliance software and an eMDR record that gathers the required data from different sources into a single file. By allowing configuration of mandatory fields, this process becomes a seamless part of the workflow by, understanding if a submission has errors and provides the steps needed to correct those errors incrementally prior to allowing submission.  Therefore when the company is ready to submit the report, errors have already been checked.

Errors are inevitable. Without a workflow and system of checks and balances in place, a required piece of data can be missed or not submitted properly. When the ESG gateway sends back an acknowledgement that your report has been received, but certain fields were missing, many companies may not know what the next steps are. An EQMS can help to eliminate errors before they happen, or correct those errors and easily allow you to resubmit in a timely manner. Moreover, an EQMS can keep track of FDA changes and conformance policies through a data mapping component of the submission tool on the developer’s side.

How EQMS Works with eMDR

EQMS eliminates the need for manual checks into reporting and “babysitting” on the part of the Regulatory Affairs team within an organization. When there are thousands of reports to submit, the manual process of combing through submissions for errors can be both time-consuming and resource intensive.  It is important to make sure that submissions are not only completed correctly, but that they are done effectively.

EQMS can help to check content for errors and move it into the CDRH medical device registration and inspections database to check if valid information is present. If there is a failure or lapse in the information, an error code is generated and notifications are submitted to the proper personnel to correct the information and keep the process / cycle moving smoothly. When the final report is submitted, an acknowledgement is generated. That acknowledgement (ack3) is the last step of confirmation that the process has been completed and no further input is required.

In the case of an adverse event, depending upon its severity, manufacturers have between 5 and 30 days to report the event to the FDA. However, some events with no immediate dire consequences may merit voluntary reporting instead. In these instances, the FDA encourages manufacturers to evaluate the issue to see if it is reportable, based on information and findings.

Until recently, this has been a common issue for many companies and medical device manufacturers. An EQMS can help to determine whether a voluntary report is warranted, as well as the severity of an event. Moreover, it can also help with gathering the information to submit in a timely manner when timing is crucial.

Decision trees, when used as part of the workflow and based on the answers provided, help organizations to determine the type of adverse event,  as well as the deadline to submit a report. Decision trees encourage consistency of process, help separate subjectivity and objectivity and have the ability to take action  in that anyone within the organization can jump in and help to resolve the issue.

More and more businesses are looking to the risk-based analysis model of dealing with known adverse events and potential adverse events. The decision tree helps you to determine the course of action, but it’s also possible to look at trends to stay proactive in terms of business and product safety. What makes this model so attractive to many companies is that it promotes a stable, repeatable and consistent process.

In terms of reporting adverse events to the FDA, gathering the information to submit in a timely manner comes down to workflow. Once the intake of a complaint has been submitted, the company moves to the triage phase before consulting the decision tree and answering the questions that surround the event.

At present, the FDA is not prescriptive on voluntary submissions. Instead, the regulatory body has left it to each individual company to determine their course of action based on internal processes, SOPs, and what a company wants to or does not want to report. However, whether a company chooses to submit a voluntary report, it’s always to their benefit to be able to address any internal issues before they become an adverse event leading to patient safety, product reliability and intended use issues.

Learn more about what medical device manufacturers need to do to become more compliant with the eMDR mandate. Download our whitepaper, eMDR: Issues Facing Device Manufacturers as FDA Moves Closer to Mandating Electronic Reporting.

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Ready For Tougher FSMA Regulations? How an Automated Process Can Help

When the Food Safety Modernization Act (FSMA) was signed into law in January 2011, it raised the standards for food safety. As a result, the food and beverage manufacturing industry saw a 41% increase in the instance of warning letters issued by the FDA. FSMA regulations only stand to get tougher, as indicated by the FDA’s new set of proposed amendments to the law that will focus on produce safety, preventive controls for human food and pet food, and changes to the foreign supplier verification program.

In the wake of FSMA and its new set of proposed amendments, it calls for manufacturers to take a more proactive approach to conducting thorough safety checks. Manufacturers should be prepared to manage potential food safety hazards by providing supporting records to ensure a risk-managed environment and quality finished product.

When a HAACP Plan Isn’t Enough

Leveraging a HAACP plan, or in the case of FSMA requirements a Hazard Analysis and Risk Based Preventative Controls (HARPC) plan, reviewing each product’s past reproduction, and monitoring how food products come and go through the production line, can help manufacturers identify a critical control point and flag it during a crucial stage of the process. Although most manufacturers currently do that today, in accordance with current Good Manufacturing Practices (GMPs) for food facilities, taking a more proactive stance and developing a strong Hazard plans that the manufacturer and suppliers stick to is important as new amendments loom.

Devising these Hazard plans isn’t enough. Implementing corrective and preventive actions (CAPA) and monitoring when those hazards occur should also be another best practice for manufacturers. Because food companies are responsible for putting plans in place, they need to be able to accurately measure those results and then determine the work flow process from that point.

Having both documented HACCP and HARPC processes and a CAPA process in place helps ensure your facility is staying on top of any hazards or issues that could relate to the quality of the final product. Leveraging technology, such as an Enterprise Quality Management System (EQMS), can help you to enforce this plan and demonstrate accountability.

Technology and Accountability: Working Hand-in-Hand

At the end of the day, it’s not just a company that’s accountable, but all of the people who are a part of that company. Technology can be leveraged to help manufacturers automate HAACP and HARPC processes and stay proactive and efficient.

Companies can easily make use of technology and an EQMS in a way that defines the company culture of quality. It shouldn’t be an added step, but a necessary part of the quality workflow processes supporting that company culture. Manufacturers can use an EQMS to identify team members and departments that play an integral role in each phase of the risk management process. Once these individuals are trained, these will be the people responsible for recording problems and expediting resolutions in an EQMS.

Using technology, manufacturers can gain greater insight into the supply chain – in real time – recording hazards, scheduling audits, and enforcing workflow processes to minimize errors and prevent other tiers in the supply chain from taking any shortcuts that may compromise quality and compliance.

In the event of facility inspections, consistent recordkeeping and standardization of processes can help reinforce standardized operating procedures. EQMS provides that central repository of data for easy access and review of incidents and corresponding corrective actions that provide assurance that a closed-loop quality process in in place.

EQMS & Technology: A Team Member That’s Always There

As we become more mobile, auditors, Directors of Quality and other managerial personnel may often out of the office on business travel; a point of contact may decide to take a vacation, or a person may leave a company.  By leveraging technology to automate checkpoints throughout the process, your team is prepared and knows what to do in the event of a quality issue without relying upon one person as the lynchpin that holds the process together.

When a red flag is raised, it’s critical to tackle the issue at hand. Time is of the essence and leveraging a system that walks everyone through the process in a logical, sequential manner ensures that no corners are cut and that no one on your team throws their hands up, wondering “What do I do now?”

Using technology to automate the process helps keep people in the loop and accountable. Rather than wonder when an issue needs to be escalated if approval or sign off has not been given for several days, it can be escalated automatically.

EQMS & the Benefits of a Transparent Process

This transparency of process is not just helpful to colleagues within your organization’s four walls, but to suppliers outside those walls. An automated, technological process can extend your organization’s culture of quality to your suppliers, holding them accountable to the same standards as your parent company. Additionally, this transparency of process is useful when dealing with larger regulatory bodies in case of an audit. In light of FSMA amendments on the horizon, leveraging technology that allows for a more robust system of supplier quality management can be impactful from a regulatory standpoint, as well.

By leveraging a web-based extension of your EQMS that can be used by second and third tier suppliers, quality events can trigger corrective action flow within the system. If an incorrect ingredient is used or packaging mislabeled, a supplier quality management system such as Stratas, can allow your organization to incorporate the supplier and document their participation in the corrective process.

Conversely, the use of technology can give your suppliers the opportunity to alert you that a change or substitution had been made and their timely communication can trigger a quality event. Transparent communications with suppliers help to extend the culture of your organization’s internal quality and provide the collaboration that many companies are looking for to be more competitive in the marketplace.

As FDA laws are likely to get even tougher, it’s even more important for organizations to maintain visibility into the supply chain for accountability and traceability purposes. It will be critical for manufacturers and their suppliers to demonstrate their plans to regulatory bodies, along with how they are enforcing those plans.

Learn more about how your organization can more efficiently prepare for more stringent FDA and FSMA regulations. Download our whitepaper, Simplifying FSMA Compliance through Technology.

Connect with Kelly Kuchinski on Google+.




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How Mobile Technology is Making Quality Management More Efficient

In the past five years, manufacturers have trained an eye on more efficient ways to mitigate risk and improve efficiency using more automated, digital quality management systems. Until recently, many quality and regulatory professionals had been using cumbersome, paper-based methods for tracking and reporting quality issues. Today, nearly all are embracing a more streamlined electronic method that increases transparency, efficiency, and visibility among even third-tier suppliers in the supply chain.

Making Mobile Technologies An Integral Part of Quality Processes

Mobile devices such as cell phones and tablets have become a staple of a working professional’s toolkit. As more professionals are on-the-move between meetings, business travel or even telecommuting from home, mobile technology plays a role in keeping them connected to the product team. While most cellphones and tablets come with email apps that allow colleagues to stay in near-constant contact, as mobile enterprise quality management system (EQMS) software becomes more widely adopted, quality professionals will have the backbone of a sound, efficient quality process (literally) in their back pocket.

The Benefits of a Mobile EQMS: Efficiency. Immediacy. Accuracy

At its core, EQMS and regulatory and product tracking software is designed with the purpose of making sure that the right information is efficiently and effectively communicated to the right people at the right time. Real-time communication of changes to a product, component, or raw materials must be conveyed quickly and accurately. EQMS acts as a centralized hub of information that issues notifications to the parties who must be informed of these changes.

Recalls directly impact a manufacturer’s bottom line. This impact is measured not only in the cost of a recall itself, but in terms of disposing of a bad batch of product, lost sales, and sometimes irreparable damage to brand reputation. And in some cases -- particularly within the pharmaceutical, medical device, and food and beverage arenas -- the cost of a recall can be measured in lives.  Quality is crucial in protecting not just profit, but people.

When time is of the essence, mobile technology will play a critical role in helping to distribute important information faster and helping to ensure that immediate action is taken to prevent escalation of an issue.

Mobile technology aims to eliminate the need for quality professionals to be tethered to their desktop computer to take swift action to ensure the end goal of a product that meets industry standards. A mobile EQMS system, such as TrackWise Mobile, may be used for intake of complaints. Quality managers or specialists who are traveling may be able to review and approve quality records as they travel.


Mobile technology also makes it possible to report a quality incident in real-time. For instance, if a quality issue is found on the manufacturing line, it can be reported at the time of identification using a mobile device. Additionally, quality professionals can use their mobile device to take and attach a photo to their report to more clearly illustrate the problem.

A complaint can be logged via the mobile EQMS while on-site rather than scribbling down the issue on a notepad and logging the issue in the system at a later time. This can save either minutes or days. Paper-based systems leave far too much to chance. Paperwork can accidentally get lost or thrown away. By using a mobile device to file a complaint, the issue is reported in real-time and personnel can request that a specific person or department take action on the item, saving valuable time.

The use of mobile technology and EQMS also circles back to accuracy. In the scenario described, the person responsible for reporting the complaint may have hastily handwritten the issue on a scrap of paper. Later, when he or she attempts to type it into a structured e-reporting tool, they may not be able to remember (or read) what they wrote. The result is potentially inaccurate and less detailed information that could have been avoided if the information was typed directly into a mobile device at the time the initial incident was spotted. Complete and accurate details can make a big difference in determining root cause and resulting actions to close out a quality issue.

Although detailed reports are important, as a best-practice, mobile applications should be streamlined compared to their desktop software counterparts. TrackWise Mobile provides the option to pare down the minimum amount of fields required to create a record – allowing for just enough detail, but not enough to detract from the efficiency of using a mobile device to report.

Secure, Efficient Communication

While mobile technology provides an added layer of convenience, users know all too well just how easily mobile devices can be lost or stolen. Quality processes, not to mention sensitive and confidential materials, need to be protected. With security in mind, TrackWise Mobile has two layers of encryption built into the app.

To ensure secure communication between the mobile device and network, the data within that channel is encrypted. Second, you must be an authenticated TrackWise user in order to log on. Since the mobile app is always online, data is not stored locally on the device, but rather in the authenticated TrackWise database. If your device is stolen, proprietary company information isn’t stolen along with it.

While secure transmission of information can give quality professionals added peace of mind, a mobile EQMS solution can also provide them with a multi-angled solution with regard to efficiency and on-the-go insight into multiple tiers of the supply chain.

- Companies that use mobile devices during the inspection process have the ability to get more accurate and specific information and turn it around to suppliers. - Redundant processes are eliminated by giving quality professionals the ability to log information during the inspection process instead of later. - Decisions can be made while traveling or outside the office and swift action can be taken to lessen the risk (and cost) of a recall.

It’s rather exciting to think of how mobile technology has the potential to transform the manufacturing of quality products and make it more efficient and accurate. While many manufacturers are only beginning to adopt mobile technology within their quality processes, in the future, it’s anticipated that they’ll be able to complete the entire workflow of a quality incident using  only a mobile devices.

Interested in learning more about where technology is taking the quality process? Check out our webinar, The Technology of Quality to learn more about tech trends and quality management tools that are improving productivity for quality professionals across multiple industries.

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Creating a Proactive Approach to Pharma CAPA via GMPs and Enterprise Quality Management Solutions (EQMS)

Mention CAPA in different companies, and you are likely to get slightly different definitions of the process. In the life sciences industry, CAPA pertains more to a formal event management and remediation system for systemic events, as opposed to minor events that occur and are corrected as they happen. CAPA as a term, started as an ISO standard for corrective actions and preventive actions. FDA’s Good Manufacturing Practices (GMP) regulations were adopted in the 1970s and have not been formally changed since that time GMPs defined quality processes and at the time of adoption were conducted manually and kept in paper-based lab notebooks.

As computers and PCs were introduced into the marketplace, manufacturing companies embraced the efficiencies of this technology revolution.  Eventually computers were used for quality processes, as well. The focus on quality became more important, and additional requirements to address quality issues were being established, driven by internal company factors as well as external agencies and patient care concerns.  At the request of the industry, the FDA created the Electronic Records Electronic Signatures (ERES) regulation. Title 21 CFR Part 11 (21CFR11 defined how electronic records and approvals would be used to assure GMP regulations would be followed in the computer age.

Additionally, ISO and the International Commission on Harmonization (ICH) have created additional standards that speak to CAPA. Although these are not explicit regulations, FDA has issued guidance documents adopting these standards. The most common FDA-issued inspection observations (483) and warning letters related to quality within the pharmaceutical industry are due to a lack of a CAPA system or a deficiency of CAPA processes.

The Intersection of CAPA and GMPs

Although CAPA requirements aren’t directly mentioned in GMPs, it is essential for pharmaceutical manufacturers to have a CAPA in place. Having a strong CAPA system and a sound Quality Management System (QMS) are interchangeable. These systems do more than just decrease the chances for a manufacturer to receive regulatory observations or enforcement. Within the realm of life sciences, CAPA has morphed into a system for tracking and managing quality events, determining root cause and taking actions to not only remediate a problem, but also preventing a problem from happening again.

GMPs, by their very nature, deal with enforcing quality of procedures and formulas. In the pharmaceutical realm, GMPs help to ensure uniformity and efficacy -- that when specific drugs are formulated, they’re made exactly the same way each time. If there is a deviation in the process, a CAPA system can help a manufacturer investigate whether that batch is safe for the market. If something goes wrong in the process, it stands as an event that requires attention. By having a CAPA process, companies in the life science space can determine whether a product is still safe and effective for its intended use, and whether it can be released to market or needs to be re-manufactured or destroyed.

Pharma CAPA and EQMS: Formula to an Effective, Proactive Approach

Stringent industry regulations and industry best practices require a more proactive approach to creating an effective pharmaceutical CAPA for post market products. An EQMS can assist in this process, helping to ensure the reliability of and access to information at each step of the way.

By making use of an EQMS to integrate CAPA and quality in the overall manufacturing process, production of post market products can be effectively managed. Here are four key elements to creating an effective pharma CAPA and how EQMS can help:

1. Immediacy

An effective CAPA process is one that operates with immediacy. When a quality event happens, it is recorded and investigated immediately. Unfortunately, in many instances of quality events, millions of dollars of raw material and equipment are invested in a process. Despite an event having been reported, the manufacturing process continues to the point of completion and then -- after considerable time, money, and resources have already been invested an investigation of an event begins. Immediacy is important in that it shortens the time for a manufacturer to decide whether to release, remanufacture or destroy a product following reporting of an event. The earlier remediation is determined, the less money it costs, potentially saving a company millions. EQMS allows you greater insight into the process and a more finely-tuned ability to detect where an event has occurred. From there, manufacturers can test that component -- as opposed to testing the finished product at the end of the manufacturing process.

2. Transparency

An EQMS can offer greater visibility in the supply chain and transparency of process. This allows decision-makers and managers to identify trends that might be happening, or failure rates. It increases the chances of determining if there is a common ingredient or process involved in multiple failure rates.  If a product has been manufactured for years without issues, and suddenly, batches of the product are failing, root cause and corrective and preventive actions need to be taken. EQMS helps to increase transparency and communication across different groups. When there is a quality event with pharma products, the signs may have already been there, but without transparency and deeper insight into various tiers of the supply chain, no one knew where and when an event occurred. What may have seemed like a minor incident managed inside a silo may have been part of a string of minor incidents enterprise-wide that contributed to a far more tangled problem.

3. Communication

Many pharma manufacturers have sites all around the world. When a root cause of a problem has been found, this can make it more difficult to effectively communicate such news -- in real time -- to the manufacturer’s worldwide network. A true CAPA process and enterprise-wide solution finds where those conditions exist and aids in correcting them. If bad raw materials are the root cause of a problem, effective communication of the problem can allow individuals and departments throughout the enterprise to question what other products are made with the same raw materials. Time, money, and effort are saved by pinpointing those products, where the material is manufactured, and/or where else does the manufacturer make that product. With an ideal CAPA system in place, corrections can be made across multiple facilities or investigations of the issue can occur and ensure that a problem is not repeated with another product or another batch of the same product.

4. Collaboration

Pharmaceutical manufacturing today no longer takes place within a company’s own four walls.  Almost all of the raw materials used come from a vast network of suppliers from around the world.  In many cases, manufacturing, packaging and distribution is outsourced to contractors, while the company licensed to sell the product is ultimately responsible for its quality and efficacy.  Most companies try to manage quality using legal quality agreements with little or no visibility into the actual quality of the supplier or contract manufacturer.  According to a recent study across all manufacturing industries, 52% of recalls were due to third party supplier or contractor caused issues.  The next generation of EQMS includes collaboration with the entire supply chain, where events, corrective and preventive actions, and changes are recorded, investigated, approved and trended on by everyone that may be involved.  Extending the EQMS and CAPA system throughout the entire supply chain helps assure the safety and effectiveness of the pharmaceutical products used by the patients who need them.

Learn more about the relationship between manufacturers and their supply chain and the role that open communication plays throughout the process. Download our whitepaper, Minding the P’s & Q’s: Managing Quality and the Globalization of the Pharmaceutical Supply Chain.







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Consumer Product Manufacturing: Greater Communication and Credibility Through EQMS

It’s common practice for many companies in the consumer products manufacturing space to outsource their manufacturing, packaging, and purchase of raw materials to suppliers and contract vendors around the globe. Despite their best efforts to increase profit margins by tapping into more competitively-priced vendors, according to a study by Deloitte, an estimated 52% of product recalls are attributed to supplier and contract manufacturer issues. Companies across multiple industries will continue to source from global suppliers and manufacturers to decrease production costs, but one way manufacturers can mitigate risks is to create a more automated and transparent process of sharing data across facilities and within their vendor network. This automation and visibility can apply to multiple departments -- from quality to shipping and receiving. However, many quality and supply chain processes are typically manual and paper-based. By utilizing an Enterprise Quality Management Solution (EQMS) to automate the sharing of incidents, complaints, and management of change, companies in the consumer product arena can eliminate cost and risk issues, as well as inefficiencies. As an added bonus, they also stand to reduce the amount of rework and product disposals that a company can have as a result of a recall.

Loss of Consumer Credibility and Trust of Regulatory Bodies

A large food manufacturer had to recall 28 million boxes of a food product due to an odd smell and taste of the product.  Further investigation showed the product’s packaging liners were the root cause of the odor, which affected the product’s quality.

As a result, the manufacturer had to dispose of the recalled 28 million boxes of their food product. This incident cost the manufacturer $70 million in recall, return and disposal charges alone. This figure did not include loss of sales, replacement vouchers to customers, or the time and money the company spent on investigating problem.  This incident also placed the manufacturer under greater scrutiny with regulators.

Ultimately, it was concluded that the source of the problem and smell was attributed to the wax used in the packaging liners that was provided by the manufacturing supplier’s supplier.

CFOs, QA Managers, and the role of EQMS

According to a 2013 Gartner CFO Technology Study, 59% of those polled cited a need for technological improvement in helping them to facilitate analysis and decision-making processes. In an area that ties most closely to this “wish list,” 45% of respondents cited a greater need for improvement on the quality of the data used to make business decisions.

Even in this day and age of technology, organizations are still struggling to effectively utilize an analytics tool. CFOs are now taking the lead in investing in analytics solutions in order to be proactive and stay ahead of issues while simultaneously managing costs for their organization. Being able to access information while traveling and addressing issues from the road is equally important. CFOs are frequently on the go and mobile solutions can allow them to stay in contact with headquarters and manage issues in real time. CFOs realize that there is a cost associated with poor quality which can significantly impact the profitability of a company. It is no longer the QA department’s job to manage quality, but the entire organization in order to stay competitive.

On the other side of the equation, QA managers may look to technology and the automation of processes to provide them with a key conduit across the enterprise and vendor network. With 80% of quality managers still managing processes via paper-based or spreadsheet-based records, an automated central repository allows everyone from the shop floor to the top floor to record audits, incidents and corrective actions for greater consistency and visibility.

An EQMS encourages consumer product manufacturers to follow a set protocol and gives insight into the process to allow them to identify an issue early on and begin the CAPA process to reduce the risk of product deviations in a specific production area. In doing so, QA managers can address everything from complaints, CAPAs, and change management.

Tasks are electronically sent to key personnel responsible for them to be sure the issue is resolved in proper time. If an issue is not being resolved, it can be escalated to the supervisor or management team to be sure the issue is properly resolved.

In addition to answering the needs of CFOs and QA managers, EQMS provides the missing integration from disparate IT systems. Alerts can be sent to various parts of the facility so that no suspect products are released into supply chain. EQMS can connect to an ERP system, which can then pick up a triggered alert for a product. From there, various departments such as shipping and production can take the necessary actions to quarantine it and prevent that product from leaving the dock door. This eliminates the need for costly product recalls and ensures brand protection.

By automating processes using EQMS, organizations can better manage incident investigations, HACCP plan process and training, and internal or supplier audits. It allows them to better pinpoint issues and their root cause, whether it is inside their four walls or with a supplier or contract vendor. This helps reduce risk and the costs associated with recalls, as well as the impact to a company’s bottom line. This saves CFOs time on having to justify numbers to shareholders. From a supply chain-wide perspective, people and departments throughout the supplier network become more productive and take a more proactive role in helping to manage risk.

A More Collaborative Approach to Supplier Information Management

Overall, synchronicity and transparency of data is key to helping enhance greater visibility across the supply chain. Depending upon the size of a company, their supplier network can be as small as 300 or as vast as 160,000 suppliers and vendors.

To ensure visibility and transparency across communications is to automate those communication processes with regard to supplier information management. In this day and age, it’s simply not effective to depend upon mail, email or faxes. These forms of communication silo information and doesn’t allow key personnel the ability to query information. By breaking down those barriers to communication by using a cloud-based system such as Stratas, it lends itself to building a more collaborative relationship with both suppliers and brand owners. This helps standardize multiple processes, standard operating procedures (SOPs), and ensure that there is no deviation from the process throughout the supplier network, so that no one takes any shortcuts.

For instance, notices of change management are usually issued at least six months in advance. A supplier may send information regarding a change to a specification of a product or component to customers well in advance. However, that notice may get lost in the shuffle, may not have reached the right person, or that person is no longer at the company. As a result, production can be held up due to the brand owner assuming the product is off-spec.

Improper notification of changes can delay production and create a bottleneck. It is also a hindrance to sharing of information. Creating more streamlined access to CAPAs, complaints, and investigations gives companies a chance to be more collaborative and proactive. Greater transparency and sharing of information prevents flawed products from entering the supply chain.

It is the responsibility of a manufacturer to communicate effectively with suppliers and create transparency across the value chain to ensure compliance, quality and product safety while ensuring profits back to its shareholders.

Download our eBook to learn more about Best Practices to Ensure Quality and Supply Chain Efficiency for companies in the consumer product space.

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What is CAPA in Medical Device Quality Management?

In the event of a product safety or functional failure or complaint, a CAPA system can help medical device companies to identify trends and what has happened in the past, as well as determine a path of remediation. These systems can help these manufacturers to be sure they do not repeat the same problems in multiple areas and transfer lessons learned between product families. From an FDA perspective, it is mandatory that medical device manufacturers have a CAPA system in place, as per the Quality System Requirements.  When the FDA conducts regular audits of medical device manufacturers, they want to be sure that companies have the right controls in place as part of their process. In such audits, the FDA will also want to be made aware of any events that have occurred within the past 12 months and see that the manufacturer can demonstrate how its CAPA system works and how it is closed.

From an auditing standpoint, it’s crucial for a manufacturer to provide evidence that they have adhered to accepted procedures. Medical device manufacturers must prepare to be sure that all phases are covered under the system procurement before it goes live. Training the right people plays a huge role in the process as the right people need to be trained on a program and system and have access to a training database. Until such time, employees cannot work within the system proper and the FDA will ask for records of employee training and test runs outside the system.

In terms of CAPA and quality management, one of the ways manufacturers can strengthen their position prior to an FDA audit is to perform self-audit. With CAPA system in place, medical device companies can use these systems to help pass audits by being able to readily answer hard questions.

Best Practices for Identifying Areas of Non-Conformance

Regardless of whether they are dealing with internal processes or external suppliers, medical device companies must take steps to prepare for inspections and identify areas of non-conformance to note in a CAPA program.

One of the first steps is to assign accountability to different portions of a project and assign timelines. If no one is assigned a timeline, no one is able to escalate an issue. Having a structured process in place can help address this problem.

According to an FDA Enforcement statistics report, non-conforming materials are the root cause of 42% of all medical device recalls in the past 5 years.   Much of this stems from external suppliers and/or partners in the supply chain. If the correct individuals are not trained to abide by these conformances, it can pose a problem to the entire process. However, determining the root cause can be more of an art than a science. A decision tree can prove useful to narrow the possibilities and find the root cause in a structured manner. When used in conjunction with prior investigations conducted and trends, this can be helpful.

When dealing with external stakeholders, medical device manufacturers only have so much control over external practices. These outside stakeholders must become a part of the supplier verification and onboarding process in order to be sure that they are on the same page as far as expectations and accountability for the final product are concerned. This is not an easy feat to accomplish -- but it is of the utmost importance.

It’s not trivial to assume that external suppliers may be able to connect to a medical device manufacturer’s internal system. They may have different security permissions and firewalls within their own four walls that may create a technological barrier.  Assuming there are no technical hindrances, it’s important that these manufacturers break down their four walls and give all external stakeholders in the supply chain greater visibility into this system.

Discovering an internal problem and connecting it to an external cause may also be a part of the problem. To be sure the root cause is truly eliminated or targeted for remediation, it’s important to validate the information that’s been received and decide if it is acceptable and makes sense with regard to the problem at hand. For instance, if a manufacturer narrows the root cause to a cable on a portion of a med device, they may decide reinforce the connection or make the soldered connection stronger.

How often quality managers should communicate with suppliers varies depending upon the type of supplier. A commoditized material supplier does not require nearly as much communication as a one that supplies a critical component to a medical device. A breakdown in communications can result in failure of a critical process -- which, in turn, may mean failure for a business.

The frequency of internal and external audits also varies, as well, depending upon agreement and how much risk a manufacturer can tolerate. Again, a critical part may require a more stringent audit. The frequency of audits can be relaxed once audits have come back with positive results or better consistent performance is recorded.

How EQMS Can Help To Drive a More Effective CAPA Process for Medical Device Manufacturers

A number of existing medical devices are often repurposed and redesigned to accommodate more specific uses derived from an original, more broadly used product.

Many times, design changes don't begin from the quality side. However, in the event of a recall or if an issue is detected, some design changes can be a part of a CAPA process. Using an enterprise quality management solution (EQMS), a notification can be issued that a change has been input in PLM noting why the design was changed, what was the root cause and what was done about the problem. This is part of the CAPA itself. Once the design change has been updated in PLM, it can notify the EQMS to close the loop of the CAPA with information on the date the change was signed off on and why.

Although many medical device manufacturers have systems of record, when some manufacturing execution systems (MES) are used, some parts of the supply chain are siloed and do not have access to that info. Manual entry of information may result in broken continuity in terms of tracking, tracing and reporting.

EQMS acts as a cohesive element, helping to tie all pieces of the supply chain to a central database. All of the relevant data is centralized, including what machinery has been used or the situation / conditions in which a problem manifested. With this information readily available to all external and internal stakeholders, when information needs to be pushed back to manufacturing or a supplier, everyone else in the supply chain can be notified.

To learn more about how medical device manufacturers can prepare for a more formal audit, download our whitepaper, Prevent Quality System Deficiencies by Conducting Effective Internal Audits White Paper.

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