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“The right tool in the hands of a skilled craftsman is the most effective method to accomplish a job well done.”

Features

GMP-ACE is not simply a database for tracking and scheduling audits and their findings. There are several databases on the market that provide this mechanism. Although GMP-ACE does have these features, it is so much more.

GMP-ACE is a highly effective and efficient tool for conducting, completing, reporting, following-up, tracking, and trending CGMP compliance evaluations.

GMP-ACE is a Microsoft Access Database that has been split into a front and back end. The back end holds the database tables where real-time compliance evaluation inputs are stored. The front end maintains the data entry forms and compliance evaluation prompts.

GMP-ACE was developed by a former FDA Senior Reviewer and Lead Pre-Approval Inspector for conducting comprehensive, consistent, and methodical compliance evaluations.

GMP-ACE Features include:

    1. Detailed Comprehensive Compliance Evaluation Prompts with Applicable Regulatory References
    2. Affirmative Response Prompts
    3. Supervisor Set-up Control
    4. Manufacturer, Contractor, Vendor, and Distribution Coverage
    5. Audit Coverage Memory
    6. Abbreviated Follow-up Compliance Evaluation Prompts
    7. Regulation Search Capabilities
    8. Automated Finding and Summary Report Generation
    9. Audit Finding, Response, and Corrective Action Tracking
    10. Audit Finding Trending
    11. Company, Facility, and Workload Management Functions
    12. Controls to Minimize Data Entry Errors
    13. Minimize Data Entry
    14. Effective Training Tool for Unseasoned Auditors
    15. Flexibility for Seasoned Auditors

GMP-ACE contains 82 compliance evaluation worksheets that prompt auditors to evaluate the applicable six quality system and their corresponding sub-systems for adequate compliance to US, Canada, Japanese, and EU regulations. GMP-ACE has been designed to be used for all drug forms, devices, APIs, excipient, contractors, and suppliers. It is the only full stand alone compliance evaluation solution on the market. It can do it all and it can do it more comprehensively, efficiently, and effectively than any other compliance evaluation tool being used today.

GMP-ACE will revolutionize the way compliance evaluations are being conducted throughout the Industry. It is far superior to any compliance evaluation program in use today; including those employed by the Regulatory Authorities, and has the potential to transform all manufacturing operations into full regulatory compliance.

 

Request a free internet demonstration of this powerful CGMP compliance evaluation tool today!

 

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