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paraFILE
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paraFILE meets all the requirements of 21 CFR Part 11.
Winchester's systems engineering experience provides the perfect foundation on which to build dependable, consistent, secure, accurate and attributable Internet-based applications conforming to all GCP requirements for Data Integrity, System Reliability, Management Control, and Auditable Quality. paraFILE is designed to be in full compliance with International Conference on Harmonization and Good Clinical Practices (ICH-GCP), 21 CFR Part 11 Electronic Record and electronic signatures and FDA's "Guidance: Computerized Systems Used in Clinical Trial."
To request a demo,
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To download the brochure,
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Features and Benefits
Detailed Audit Trails
Mobile, desktop, and web-based access
Robust security
The Check-in/check-out capability
Version control over content.
Full-Text Search
Collaborative authoring, review, and approval
Mobile Usage of Documents
User-defined content formats
21 CFR Part 11 Compliant
Validated system
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