© CERULEAN ASSOCIATES LLC

Lean FDA Part 11 Compliance

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.

Cost-Effective Frameworks

  • 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 and data mapping
  • Business-focused IT compliance procedures
  • Practical data archive 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

Receive

  • Compliance with FDA requirements for data integrity and computerized systems
  • Information integrity and data quality
  • 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.

Call +1 757 645 2864 or email us. We offer a free half hour consultation to new clients