Data Integrity

Video
This webinar provides an overview of new and forthcoming ISPE GAMP ® Data Integrity guidance and real-world experiences on applying data integrity in the field. The speakers will address the following topics: Overview of...
iSpeak Blog
Followers of FDA warning letters and Form 483s will have noticed that over the last 12 – 18 months, there have been increasing mention of data integrity issues around manufacturing data, often as a result of outdated equipment and practices, such as: No...
InTouch
ISPE launched its complimentary Pharma Best Practices Webinar Series in April. The debut was outstanding, drawing more than 850 registrants and over 500 real-time participants representing 62 countries and six regulatory agencies from around the world.
Features
The Pharma 4.0 Special Interest Group is focusing on key technologies that will modernize pharmaceutical manufacturing and facilitate digital transformation. These technologies include digital twins, augmented reality, artificial intelligence, big data and analytics, mobiles, cloud, advanced...
Webinar Series
ISPE members have the benefit of unlimited access to the webinar recordings - even if you don't sign up for the webinar. Each webinar will feature leading subject matter experts covering critical, relevant topics in...
News & Press Releases
05 June 2019
ISPE announced the release of their latest guide, ISPE GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records . This guide features the expectations and requirements for data integrity and quality management in GMP facilities. Industry...
Guidance Docs
The ISPE GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records provides practical and pragmatic advice on areas such as regulated records, data flows, and risk management approaches, with particular focus on process control systems, manufacturing execution systems, and the interfaces and relationship between them.
iSpeak Blog
FDA’s recent released Guidance for Industry on Data Integrity and Compliance with Drug CGMP Questions and Answers (CGMPs also known as current Good Manufacturing Practices), clarifies data integrity’s role for drugs and biologics as required in 21 CFR...
Features
Data is an important factor that is reshaping the pharmaceutical industry and triggering significant innovation. Vertical integration of equipment can represent an optimal solution to manage the increasing flow of data efficiently, innovate the manufacturing environment, and fulfill data integrity...