Skip to Content

Compliance for Life Sciences: New Key Topic Area for FDA Part 11

Compliance with regulations is for the Life Sciences industry a global, on-going and always changing topic. For the industry it is crucial to create trust with authorities, people working in healthcare and last but not least with patients. It’s crucial for the industry not to loose the “license to produce”, but it is also extremely costly and not generating revenue.

For me as an enduser of medical products, whether these are drugs or infusions or medical devices I say thanks that these regulations exist. I trust that I really get the drug with the ingredients written on the leaflet. And I trust that the medical device really works as it should. – Unfortunately, there had been rare examples when this wasn’t the case with disastrous consequences of for example babies dying due to the wrong labeling on infusions.

As an employee of a software company providing software to Life Sciences companies also in GxP (Good clinical, laboratory and manufacturing Practices) relevant areas I ask myself: “What can I do to help Life Sciences companies to fulfill their compliance tasks?” – Well, fortunately I do not have to invent the wheel from the beginning. There are already regulations in place for computerized solutions and processes within the Life Sciences industry. So, my colleague Dr. Christoph Roller and myself, we concentrated on the investigation of SAP products on one very important regulation, the U.S. FDA Title 21 CFR Part 11. Please find in our new key topic area “FDA Part 11 Compliance Assessments” our investigations of SAP Business Suite components and applications as well as of SAP NetWeaver components and applications. – Besides, those Part 11 Compliance white papers published in BPX, we’ve got others in work (e.g. for SAP Document Management, SAP Records Management, etc.).

I hope, that Christoph and I can help with these contributions to make life for you, our Life Sciences customers and prospects, a little bit easier. – And as an enduser of your industry I go on trusting in the execution of compliance and patience safety.

Be the first to leave a comment
You must be Logged on to comment or reply to a post.