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, 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.

Sample Downloads

Checklist: 27-Point records & document retention self-assessment
Article reprint: How to meet compliance and records requirements of the US FDA
Flowchart: 11-step records management program implementation overview

More Resources

Article reprint: Pharmaceutical Executive Lessons from the Courtroom
List of Regulations Impacting Record and Document Retention
More FDA recordkeeping articles