The BPIT Compliance workstream has published an industry response to the IT Data Integrity guidelines provided by regulators. An area that has been a major focus for inspectors in recent times.
The guidance and supporting template provides clarity and agreement of the regulatory requirements, a shared view of which controls to implement within a company, and offers best practices. This results in a common response to regulators and achieves increased confidence in companies’ approach to compliance.
To support those wishing to put these guidance papers into practise, the Compliance workstream has broadcast two webinars which were viewed live by over 100 participants and are now available on iMeet Central here.
The Agile webinar, presented by Jodi Dey, Pfizer and David Lake, Shire, shared current member company experience in using an Agile approach and explained the benefits of the Agile guidance paper. These benefits include defining a future state and plan of how to get there, providing the basis for developing company guidelines and helping to accelerate the adoption of Agile in the GxP environment.
The Data Integrity webinar was presented by Mike Stroz, Biogen and John Creggy, Pfizer. Through the broadcast the audience learned more about how both BPOG’s Data Integrity for the BioPharmaceutical Industry position paper and the Universal Data Integrity System Assessment Template could benefit their company. The Data Integrity papers are being used by member companies in a number of ways including providing a benchmark against internal practices, a sanity check for current company checklists including new ideas, and is helping to drive the implementation of data integrity programs.
You can download the Data Integrity position paper here
You can download the Assessment Template here
You can download the Agile guidance here