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http://www.fda.gov/ora/compliance_ref/part11/
compac press release.pdf
21 cfr 11.pdf
ComPac GxP is an out of the box set of tools than can be integrated into your Domino environment to achieve 21 CFR part 11 compliance.
It's all about the audit trails!
Lotus Notes and Domino offers an ideal platform for RAD application development in a regulated environment. By leveraging the security and digital signature features native to the platform, an application can be designed to meet many of the conditions of part 11.
Winchester Business Systems' ComPac GxP software can be easily integrated into any Notes application, both existing and future development, to achieve complete compliance with FDA guidelines.
ComPac GxP module features:
· Part 11 compliant field level auditing
· Digital Signature
· Subsequent authentication
· Access/security logging
· Rules and configuration setup
· Web Authentication
· Captures reason for change
ComPac GxP software from Winchester Business Systems is the only complete 21 CFR part 11 solution for Lotus Notes and Domino. Winchester also offers full consulting services for system validation and compliance readiness.
To request a demo,
Click here.
To download the brochure,
Click here.
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Features and Benefits
ComPac GxP provides a fully human readable audit trail at the field level for each document in the system. Utilizing Winchester's Snapshot technology,
The ComPac GxP authentication module meets the guidelines set forth by the FDA for subsequent saving or signing of records in both a new session and in a continuous session.
Access to an application can be logged using the ComPac GxP tool set. When a user enters the database, the event is captured, the termination of that session is also captured and a log is written with the length of time of each session.
The ComPac GxP access control module creates a full audit trail regarding the document, showing the access changes, the previous levels and/or roles and subsequent changed levels and/or roles.
The system allows the database manager to define fields that require a reason for change.
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