Compass' Document Control System
21 CFR 820.40 instructs companies to establish and maintain procedures to control all documents required by Part 820 of the Quality System Regulation established by FDA.
- Document Approval and Distribution
- Designate person(s) to review documents for adequacy and approve prior to issuance.
- Document approval includes date and signature of approving person(s).
- Document Changes
- Designate person(s) to review documents for adequacy and approve prior to issuance.
- Communicate changes to the appropriate personnel in a timely manner.
How Compass complies
Compass provides supports formal and informal reviews as well as change mangement. Both of these mechanisms allow product teams to comply with 21 CFR 820.40 and 21 CFR Part 11 with ease.
Documentation is a significant piece of a device submission. A few primary goals of good documentation are:
- Demonstrating a compliant quality management system is in place throughout the entire design process.
- Demonstrating your device has been developed and designed through the design controls process, ensuring the product is designed and validated based on the specified user needs.
- Demonstrating a solid risk management process throughout all stages of development and manufacturing.
Compass helps teams maintain all documentation relating to the product design. These documents are automatically generated by Compass based on information entered through the various exercises performed during device development.
Document Control Features
The template supports both formal and informal reviews of all documents within a given project. All reviews are controlled by Compass’ comprehensive workflow feature. Unique electronic signatures for every approval in a review cycle are 21 CFR Part 11 compliant.
The template supports a change management process, controlled by workflow. Approved changes can be implemented and approved for release.
The template exports to PDF and Word and documents can be taken from Compass and stored in the official system of record for the organization.
The template comes with full auditing capabilities so that you know what was changed when, and by whom. Everything in the system is audited, from permission changes to configuration additions. Auditing is controlled based on the workflow phase, only tracking changes when necessary. Audit logs can be exported in case of audit.
SUBMISSION-READY ARTIFACTS
PDF submission-ready artifacts
at the click of a button.
OPEN API
Connect other programs to Compass to transfer data between the two.
REQUIREMENTS MANAGEMENT
Manage all aspects of requirements for your project in Compass.
AUDIT TRAIL
See what changed, by whom, and when with Compass’ full auditing options.
RISK MANAGEMENT
Manage all risk-related activities in Compass. Custom scoring and color settings are available.
ALLOCATION MATRICES
Easily allocate design inputs, user needs, etc. to sub-systems of the design.
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