21 CFR Part 820 QSRs - Device
Biologics - Clinical - CMOs, CAOs...
CAPA Manager ensures that open issues are tracked completely to resolution. Built-in workflows allow tasks to be assigned to individuals, including reminders to ensure that the CAPA progresses and follow-ups are completed and documented.
CAPA Manager's Workflow implements a closed-loop process for:
• Identifying (Document the Issue)
• Investigating (Evaluate the Cause)
• Action Planning (Define Actions to Correct and Prevent Re-occurrence)
• Implementing (Assign and Track Assigned Actions)
• Monitoring (Periodic Challenge option)
• Closing out the CAPA's with a full document trail
Records who, when and why a changes are made without obscuring original data.
12 styles of fixed reports and charts to assist with managing your CAPA observations and findings. Exports for MS Excel - Export your records and table data to MS Excel for your customized reporting.
Sort, categorize and organize your observations and findings to ensure that you never lose, miss or drop any critical issues. All records are secure and kept open, until formally closed and resolved through remediation and/or deviation.
• CAPA Management Software is built upon a robust Microsoft Sequel Server Database with superb designed Functional Specification Requirements and tested User Specification Requirements to ensure not only a compliant functional software product but an easy to use software product.
• The software meets the requirements of the US FDA Title 21 CFR Part 11.10 (a) through (k), and has extensive validation to prove compliance requirements.
• The most important facets to meeting the 21 CFR Compliance requirements was to ensure that there existed a fully documented, validated system (21 CFR Part 11 (a)) and a simple, easy to use audit trail (21 CFR Part 11 (e)).
• Very simplistic in nature, the CAPA Manager only provides CAPA Management operations. The CAPA Manager is not set up for Electronic Signatures which provides a less regulated requirement under 21 CFR Part 11.100 (c), the need to ‘register’ the software with the FDA. A software structure which takes very little time to set and start using.
• CAPA Manager Services also offers import capabilities for Companies who currently use other Software such as Microsoft Excel, Microsoft Access and other non-robust databases and spreadsheets.
• CAPA Manager also has qualified data entry technicians to assist with supporting paper logs as well.