The Value of an Enterprise Quality Management System in Pre-Clinical and Clinical Development

After working with hundreds of pharmaceutical companies for years, I have noticed that while there is a single company name on the building, there are dividing walls within.  These walls tend to be built between the groups that follow different regulations.  You have your pre-clinical group that follow cGLP requirements and perform early testing, both laboratory and animal, on possible new drugs and compounds.  Behind the next wall you have the clinical group that follows cGCP requirements and are testing drugs on humans, with the main goal of keeping the patients safe and collecting real and accurate data on test subjects.  Behind the next wall is the manufacturing group that follows cGMP requirements and manufactures the approved finished product.  You have three different groups, following different rules, and performing different tasks that are all part of the lifecycle of a pharmaceutical product. In most cases, each of these groups has set up their own systems and processes to support what they do.

Is there a place for a cross-functional Enterprise Quality Management System (EQMS) that can support the unique processes and activities of each group?  With proper planning and cross-functional support, it is not only possible, but advantageous to the company these groups work for.  Let’s take a look at just three of the many processes where a common system can be beneficial.

The first process is auditing, which can be the most challenging.  All three groups perform audits which can have observations or findings, and these observations can create CAPAs.  From a high level, it looks the same.  However, when you get close to the actual activities, you can see what they are auditing –the data they are collecting can have some common information, but the bulk of the data collected is different.  With increased global outsourcing of pre-clinical and clinical trials and manufacturing, the ability for each group to perform audits remotely is critical, and can be accomplished with the offline capabilities of the TrackWise Audit Execution Package.  Auditing in a configurable EQMS allows each group to collect their unique data and follow their own processes, while providing visibility and enabling analysis of the information collected across the entire lifecycle of the product.

The second process is small batch manufacturing.  In pre-clinical and especially clinical research, small batches of test products are manufactured.  Larger batches are manufactured as clinical trials are performed on a larger group of patients.  Tracking and managing manufacturing deviations, lab results, complaints and the resulting investigations, root cause analyses and CAPAs are critical to assure consistent product is being administered and tested.  Managing and controlling changes are equally critical.  All of these are standard, proven processes in EQMS systems.

The third process is one that many companies find difficult to manage consistently.  During the pre-clinical and clinical processes, there is ongoing correspondence with regulatory agencies.  This correspondence can be through letters, faxes, phone calls, e-mails and even text messages.  Some of these correspondences result in commitments made to these agencies.  In most cases, this process of managing correspondence and commitments is controlled by small groups of people, and if tracked, it is done in spreadsheets that may or may not be visible to all who may need to be aware, or may be responsible for meeting a commitment.  TrackWise is a solution that can manage the correspondence and commitments and the related tasks.  As an enterprise-wide system, this information can be available to those in the day-to-day operations as well as to those at a higher level that are involved in various decision making processes about research and trials being conducted.

Using an EQMS to manage quality across the whole organization helps to break down the walls between the groups that are critical to a successful launch and ongoing sales of pharmaceutical products that are proven to be safe and effective.  Having visibility to all the quality events during the entire lifecycle of a product allows for the release of a finished product that can be trusted by the marketplace and protect a company’s positive reputation.

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