21 CFR Part 11 – FDA Compliance & Validation

| 28th Jan 2015 | Satish Pala | 32 min

FDA is increasing emphasis on scrutiny of computer systems validation and adherence of 21 CFR part 11 compliance to companies under FDA regulatory jurisdiction. A third of FDA”s recent warning letters have been with respect to improper or ineffective validation practices. Increasing use of automated manufacturing and quality system is forcing exposure of computer systems. Validated computerized systems are integral for producing accurate, reliable and consistent data. For many small to mid-sized organizations, meeting the regulatory requirements is a daunting task and Part 11 compliance is a major focus for audits.

1. Defining the scope of 21 CFR Part 11

2. Compliance Assessment

3. Validation of Computer (validation plans, Check lists and Test Reports)

4. Implementation and Documentation Recommendations