Get expertise from a former CIO who trained as a Part 11 inspector
Cerulean’s managing director spent a career building IT departments, record & document control systems, ensuring data integrity, inspecting for 21 CFR Part 11 and EU Annex 11 compliance … and has successfully defended decisions against lawyers, auditors and inspectors alike.
- 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
- Specialized corporate workshops on applying current FDA expectations for Part 11, the role of IT in effective regulatory compliance, and more
- Information integrity and data quality
- Compliance with FDA and EMA requirements for electronic data integrity
- 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’re 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
- Template: Determining 21 CFR part 11 applicability SOP
- Sample agenda for Cerulean’s onsite corporate workshop FDA Part 11 Compliance Today
- Recorded seminar & resource kit: Data Quality & Record Integrity in Regulatory Submissions – NDA, ANDA, BLA, 510(k)