Get help from an expert who trained with the authors of 21 CFR 11
Cerulean’s managing director trained with the authors of FDA’s 21 CFR § 11 to inspect for Part 11 compliance amidst a career building IT departments, record & document control systems, and ensuring electronic data integrity. He has successfully defended decisions against lawyers, auditors and inspectors alike, and rescued multiple clients from FDA inspections. Get help from an expert who knows intimately both sides – the FDA’s and yours.
- Comprehensive, easy-to-follow SOPs and policies for FDA and EMA compliance
- Mock FDA Part 11 inspections and gap analyses
- Integration with your current quality system
- Computer system validation plans, training, and assistance
- Process mapping and value stream analysis
- Business-focused IT compliance procedures
- Practical data integrity controls
- Simple, risk-based computer validation strategies
- Streamlined FDA regulatory compliance controls and strategies
- Development of defensible documentation in line with regulatory requirements, best practices and business capabilities
- Private corporation workshops on applying current FDA expectations for Part 11, the role of IT in effective regulatory compliance, and more
- Compliance with FDA requirements for data integrity and computerized systems
- Information integrity and data quality tools, techniques and help
- Adherence to current ISO and GAMP expectations
- Personalized, individual attention and expert advice from someone who’s walked in your shoes & trained as a Part 11 inspector
Plus one full year of follow-up support and advice if you are ever audited or inspected.
- Checklist: 27-Point part 11 & annex 11 self-assessment
- Article reprint: FDA 21 CFR 11: where is FDA’s special enforcement headed?
- Article reprint: 21 CFR part 11 revisited
- SOP sample: Determining 21 CFR part 11 applicability and validation need SOP
- Recorded seminar & resource kit: Data Quality & Record Integrity in Regulatory Submissions – NDA, ANDA, BLA, 510(k)