EDC Case Studies

Read about how Explore Consulting has helped Seattle biotechnology companies implement Electronic Data Capture systems for clinical trials and comply with regulations by auditing vendors.

21CFR11 White Paper

Download the white paper on Risk Based Approaches to 21 CFR Part 11 by Steve Griggs

FDA Guidance on Clinical Systems

Understand changes to the FDA Guidance on Clinical systems by reading our side-by-side comparison of the new and old versions.

View the Comparison

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21 CFR Part 11 Compliance

Title 21 of the Code of Federal Regulations Part 11 (21CFR11) defines the rules for electronic records and electronic signatures for life science companies. These rules and their interpretation are currently under scrutiny and revision. Meanwhile, companies are expected to comply with documentation of good practices that minimize risk to patient health.

21 CFR Part 11 ComplianceExplore Consulting is engaged in the debate over regulations and compliance with authors, reviewers, inspectors, and manufacturers. We utilize Good Automated Manufacturing Practices (GAMP4) as defined by the International Society for Pharmaceutical Engineering (ISPE) in our auditing services. We help our clients implement electronic records and signatures while complying with the latest rules, guidelines, and interpretations.

To find out more about how Explore Consulting can help, contact us.