FDA Data Integrity & Part 11 Compliance
Get help from the expert who trains FDA on advanced data integrity
Cerulean’s managing director originally trained with the authors of FDA’s 21 CFR § 11 to inspect for Part 11 compliance then followed with a career building compliant departments, record & document control systems, and ensuring electronic data integrity.
For more than 20 years, he has successfully defended decisions against lawyers, auditors and inspectors alike, and rescued multiple clients from FDA inspections. Today, he trains FDA investigators and district directors on advanced data integrity topics and data fraud.
Get help from the 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
- Data Integrity controls across the record lifecycle
- Specific FDA data integrity inspection techniques to master and prepare for
- Practical data archive controls
- Simple, risk-based computer validation strategies
- Streamlined FDA regulatory compliance controls and strategies
- Defensible documentation to prove compliance and ensure cost-effective best practices
- Specialized corporate workshops on current FDA data integrity expectations, Part 11 compliance, the role of vendors, and 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
- Adherence to current ISO and GAMP expectations
- Risk-based decision-making models aligned with the latest ICH, EMA and FDA guidance
- 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.
Email Cerulean today. We offer a free half hour consultation to new clients