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IT Compliance - Revised FDA Part 11 and EMEA Annex 11

Drawn upon career experiences building IT departments, record and document management programs, and inspecting for Part 11 compliance.

 

Cost-Effective, Low Maintenance Solutions

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

• Revised FDA Part 11 and EMEA Annex 11 audits and gap analyses

• IT compliance program development, implementation, training and assistance

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

• Development of cost-conscious validation programs in line with regulatory requirements, best practices guidance, and business needs

• Specialized corporate workshops on IT compliance, data integrity, Part 11 revisions

 

Receive

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

• Adherence to the updated requirements of EMEA Annex 11 and the revised 21 CFR Part 11

• 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

• SOP:  Determining Part 11 Applicability  (PDF)

• Article Reprint:  Improving Your IT Compliance Return on Investment  (PDF)

• Article Reprint:  Part 11 Compliance and Quality by Design  (PDF)

• Checklist:  Overall IT Compliance 27-Point Self Assessment  (PDF)

 

More Resources

• Recorded Seminar & Resource Kit:  Understanding and Implementing the Revised FDA Part 11 and EMEA Annex 11

• Recorded Seminar & Resource Kit:  How to Improve Data Integrity in Your Submissions

 

What to Do Next

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