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FDA Records Management and Compliance Services

Designed exclusively for pharmaceutical, biotechnology, and medical device firms - from startups to multinational companies - and drawing upon career experiences building records and document management and retention programs ... and defending them to inspectors and litigators alike.

We know how to define your product lifespan so you can determine what records to keep and for how long ... do you?

 

Cost-Effective, Low Maintenance Solutions

• Comprehensive, easy-to-follow SOPs, forms and policies

• Information and records audits and gap analyses

• Records management program development, implementation, training and assistance

• Electronic data and records integrity controls, strategies, assessments and advice

• Development of document retention schedules in line with FDA regulatory requirements, best practices guidance, and business needs

• Discovery surveys, litigation support and expert witness

• Specialized corporate workshops on records management, document retention, data integrity, and more

 

Receive

• Compliance with GLP, GCP, GMP regulations plus ICH, GHTF, GAMP standards

• Adherence to the record-keeping requirements of the updated ISO, EMEA Annex 11 and GMPs

• Personalized, individual attention and expert advice from someone who's walked in your shoes

• One full year of support and advice if you're ever audited or inspected

 

Sample Downloads

• Flowchart:  Implementing an FDA-Compliant Records Management Program  (PDF)

• Article Reprint:  How to Protect Your Records by Really Trying  (PDF)

• Template:  Sample Small-Midsize Business Retention Schedule  (PDF)

• GLP Supporting Statement:  FDA OMB GLP Record-Keeping Requirements Expected  (PDF)

 

More Resources

• Recorded Seminar & Resource Kit:  FDA Records Requirements for GLPs, GCPs and cGMPs

 

What to Do Next

Contact us today.  We offer a FREE ½ hour consultation to new clients.