If you look at the past warning letters of the FDA there is almost always one infringement recorded – and that is non-compliance of data integrity.
However, data integrity should be familiar to companies within the regulated industry, since the topic of data integrity is mentioned in many regulations (e.g. EU Eudralex Vol. 4 Chapter 4, Annex 11, 15; US 21 CFR Part 210, 211, 212, Part 11 and WHO Annex 2) and has been a relevant aspect in the GAMP® 5 (published in 2008!).
Recently published papers provide guidance and best practice approaches, which should help companies to comply with data integrity requirements.
Our presentation will summarize the most relevant data integrity requirements and potential “traps” in this area. And it will show the chances and opportunities, that data integrity activities might offer.
Ingo Baumann works in a leading role as Partner for Thescon. His background is Chemical Engineering; he graduated from the renowned European University of Applied Sciences Fresenius. Ingo has worked in software and consulting companies (IBS, now Siemens Industry Software, and IDS Scheer) before joining Thescon. With a track record of more than 18 years of experience in regulated industries, he is an expert in the area of Computerized Systems Validation (CSV), GMP (Good Manufacturing Practice), GDP (Good Distribution Practice) and GLP (Good Laboratory Practice), and SOX implementations. Furthermore, he is a senior advisor for regulated Master Data and Product Lifecycle Management.
Thescon is a recognized consulting partner for the pharmaceutical industry, wholesalers, medical devices, the chemical industry, biotechnology and food packaging, safety and distribution logistics. Areas of proven expertise cover regulated industries processes, compliance & quality management, IT system selection, and project management.