Times are changing. Increasing competition, regulatory scrutiny and tightening margins are a few of the challenges facing Life Sciences Companies. As a result, drug and device manufacturers are evaluating every aspect of their operations to identify opportunities for greater efficiency and productivity.
Whether you are responsible for ensuring the quality of your company’s biologics, class IV devices, organic ice cream, or latest line of home automation products, you are liable to have five core responsibilities.
Analysts predict that by 2020, there will be more than 50 billion connected devices, impacting industry and our daily lives. From mobile devices and wearable technology to cloud computing and IoT platforms, think about the data being generated and how it’s being leveraged to gain business insights and create new customer experiences.
As part of UBM's series of conferences and seminars in India, the latest was on Unannounced Audits, held at the Westin Garden City in Mumbai on August 29 & 30. Sparta Systems was one of the sponsors and I was one of the presenters.
Regulatory oversight for drug manufacturing has significantly increased due to product quality issues in the pharmaceutical industry. This can be attributed to significant growth of new drug applications with broadening global sourcing and distribution.
I attended the annual American Society for Quality’s World Congress, which was held this year at the Wisconsin Center in Milwaukee. It was attended by quality professionals in all facets of life, industries and positions.
On March 1, 2016, the Organization for International Standardization, (ISO) published ISO 13485: 2016. The introduction to ISO 13485:2016 states the following in paragraph 0.4 - Relationship with ISO 9001:“While this is a stand-alone standard, is it based on ISO 9001:2008, which has been superseded by ISO 9001:2015.”
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.
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.
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).
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.
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.