© CERULEAN ASSOCIATES LLC

FDA Records Retention & Compliance

Designed exclusively for FDA-regulated firms

Cerulean’s advice draws upon career experiences building & running records management departments, defending decisions to inspectors and litigators … and being hired by outside counsel to scrutinize and tear down the programs of others.

Cost-Effective, Flexible Solutions

  • Comprehensive, easy-to-follow SOPs, forms & policies
  • Records retention audits and gap analyses
  • Records management program development, implementation, training and assistance
  • Electronic data and records integrity controls, strategies and assessments
  • Development of document and email retention schedules in line with regulatory requirements, industry best practices, and business practicalities
  • Discovery surveys and litigation support
  • Specialized corporate workshops on records management principles, applying defensible documents to your organization, and more

We can show you how to define and document your product lifespan to minimize your liability under FDA record-keeping requirements.

Receive

  • Defensible documents policies and retention schedules right for you
  • Compliance with GLP, GCP, GMP & QSR record-keeping requirements
  • Adherence to the records retention rules of FDA, Health Canada, and EMA
  • Fidelity to ICH, GHTF, IMDRF & ISO standards
  • Cost-effective conformity with FDA Part 11 & Annex 11 rules for electronic records
  • Personalized, individual attention and expert advice from someone who’s walked in your shoes
  • One full year of expert support and advice if you’re ever audited or inspected

Need an independent snapshot of your records retention and compliance status…?  See our Mock FDA Audit and Gap Assessment service.

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