Data integrity is a fundamental requirement for the regulated health sector, since decisions and assumptions about product quality and compliance with applicable regulatory provisions are made precisely on the basis of data" (Institute of Validation Technology) .
In this White Paper we have sought the answers to some fundamental questions for the world of Pharma and Life Science, such as:
- What is meant by Data Integrity (data integrity)?
- Data Integrity: Why Has It Become a Hot Topic?
- How should the data be, according to the requirements for "Data Integrity"?
- What are the key requirements for Data Integrity in Life Science Supply Chain IT?
DOWNLOAD THE COMPLETE WHITE PAPER: Data Integrity and factory systems_GAMP
As of March 2015, the MHRA, the UK's Medicines and Healthcare Regulatory Agency, has published a document (MHRA GMP Data Integrity Definitions and Guidance for Industry – March 2015) on what the regulatory body expects at the level of Good Manufacturing Practice (GMP) regarding data integrity for the pharmaceutical industry, in order to ensure that the medicines produced are safe in terms of Quality.
This guidance is complementary to existing EU GMP guidance and should be read in conjunction with EU member states' national legislation for medicines and GMP rules.
The guide entitled “MHRA GMP Data Integrity Definitions and Guidance” was written to emphasize the importance of governance throughout the data lifecycle. Considerations such as correct organizational procedures and system access controls must be prerequisites.
To learn more, download the free PDF.
DOWNLOAD THE COMPLETE WHITE PAPER: Data Integrity and factory systems_GAMP