The ISPE GAMP® Guide: Records and Data Integrity provides you with principles and practical guidance on meeting current expectations for the management of GxP regulated records and data—ensuring that they are complete, consistent, secure, accurate, and available throughout their life cycle. This guide addresses the integrity of GxP records and data used within the regulated life science industries including pharmaceutical, biological, and medical devices. The guidance is intended for regulated companies and suppliers of systems, products, or services in this area, as well as a providing a useful reference for regulators. Key concepts that you can take away from this guide include:
Structure of the ISPE GAMP® Guide: Records and Data Integrity:
Purchase your electronic copy today and receive it to your inbox in minutes!
Thank You to All Guide Contributors:
Chris Clark, TenTenTen Consulting, United Kingdom * Colin Jones, Conformity Limited, United Kingdom * Tony Margetts, Factorytalk Co., Ltd., Thailand * Mark Newton, Eli Lilly and Company, USA * Arthur "Randy" Perez, Novartis (retired), USA * Nigel Price, QCDI Ltd., United Kingdom * Chris Reid, Integrity Solutions Ltd., United Kingdom * Mike Rutherford, Eli Lilly and Company, USA * Lorrie Vuolo-Schuessler, GlaxoSmithKline, USA * Charlie Wakeham Waters Australia Pty. Ltd., Australia * Christopher White, Alexion Pharmaceuticals, USA * Guy Wingate, GlaxoSmithKline, United Kingdom * Sion Wyn, Conformity Limited, United Kingdom
In the pharmaceutical industry, which is highly regulated, aseptic processing is a critical component that ensures the sterility of products. Regulators have a set of comprehensive requirements that minimize the risk of contamination. Regulators set the requirements; however, the industry has an obligation to the patients who rely on and expect a drug that is safe and free of contamination....
Like any investment in digital manufacturing systems, demonstrating business payback before and after investment is critical to getting MES projects approved and verifying profitability after investment. Whether it is introducing MES, expanding it to additional sites, switching software, upgrading existing software, or developing electronic production records (EPR) for new drug products,...
Sustainability is emerging as a pivotal force influencing the pharmaceutical industry’s dynamics and steering companies towards transformative change. The focus of this analysis is to delve into the sustainability key performance indicators (KPIs) of prominent pharmaceutical players, namely Pfizer, Sanofi, Glaxo Smith Kline (GSK), Becton Dickinson, Johnson & Johnson, Abbott, Eli Lilly, and...