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ComPac GxP
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Summary
Ease of Use
JumpStart
Related info
Requirements
Technical Bulletins
ComPac GxP - JumpStart is a structured mentoring program where Winchesters Professional Services team provides instruction to your internal technical teams on developing applications in a regulated industry. Winchester Engineers have developed and deployed hundreds of application in a regulated environment. In the JumpStart Program our engineers will share their experience with your developers and perform mentoring on the Best Practices that we have defined. Additionally our QA and auditing personnel have provided instruction on the applicable regulation and FDA guidelines that need to be followed when developing and deploying applications in a regulated environment. Some of the areas covered include:
21 CFR Part 11
Writing Compliant Agents and Event Driven Code
Form Events and Triggers
System Design
Validation
Audit Trails
ComPac GxP Integration and more.....
ComPac GxP - JumpStart is offered in conjunction with our ComPac GxP program or as an adhoc offering for companies that wish to get and stay compliant with their own applications.
To request a demo,
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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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