Compliance Group

 Key aspects of FDA Computer System Validation include: 1. 21 CFR Part 11 Compliance :    - Part 11 of Title 21 of the Code of Federal Regulations (21 CFR Part 11) sets forth the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. Compliance with Part 11 is crucial for computer systems used in regulated industries. 2. Data Integrity:    - Ensuring the integrity of data generated and maintained by computerized systems is a key focus. This involves implementing controls to prevent and detect errors, omissions, and alterations of data. 3. Risk-Based Approach:    - The FDA encourages a risk-based approach to computer system validation. Companies are expected to assess and prioritize validation activities based on the impact on product quality, data integrity, and patient safety. 4. Validation Lifecycle:    - The validation process typically follow...

  21 CFR Part 11 Checklists. We've come a long way....or have we? The year is 1997. Bill Clinton is in his second term, Windows 95 is revolutionary, a laptop only weighs 6-8 pounds and  21 CFR Part 11 , the US Food and Drug Administration's (FDA) regulation on electronic records and electronic signatures went into effect (enforcement to begin in 2001).  Two decades ago, most software used in the life-sciences industry was not compliant and many to most quality processes were managed via paper record. Read more .