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I.Q. Auditing has spent years developing innovative and unique CGMP tools and services to enhance your quality management and compliance objectives. We appreciate the degree of difficulty it takes to successfully employ an effective Quality System in the pharmaceutical, biotech, biologics, cell / tissue, blood, and medical device manufacturing processes.

We offer the following tools and services to assist you with this endeavor:

 

GMP - ACE

(Auditing Software)

GMP-ACE is a powerful CGMP compliance evaluation database that facilitates consistency across auditors and audits. It was developed by a former FDA Senior Reviewer and Lead Pre-Approval Inspector to provide an effective CGMP auditing standard. It can be used to schedule, execute, report, track, and trend internal/external audits of suppliers, distributors, manufacturers, and test labs. Audit coverage includes drug, biologic, cell / tissue, blood, and device products. Quality principles found across US, EU, Canada, and Japanese regulations were harmonized to create auditing prompts within the database.

GMP-ACE is the most comprehensive CGMP evaluation tool on the Market today!

For more information, please visit our gmp-ace.com website or contact I.Q. Auditing for a free demonstration.

 

CGMP Consulting Email / Phone Support

When you encounter an atypical regulatory or compliance issue, do you wish you could get a professional, objective evaluation of the situation without paying high consulting hourly fees? I.Q. Auditing offers this service to provide prompt email and/or phone CGMP feedback without charging for every minute of time required to respond to the inquiry. For a very reasonable annual subscription, you can get real-time CGMP or CMC input without being invoiced for each event. This flat fee service is available as a stand alone service or as an add-on service to GMP-ACE. Please contact I.Q. Auditing for specific pricing.

 

On-Site Compliance Evaluations / Mock Inspections

Sometimes you need a third party to evaluate the health of your Quality System or prepare your site for a regulatory inspection. I.Q. Auditing will conduct a compliance evaluation or mock regulatory inspection at your site for a set daily rate. The set daily rate includes all preparation work, up to ten hours per day on-site, a findings report at the close-out meeting, and a final summary report within two weeks of the last on-site day. A minimum of three on-site days are required. Recommended corrective actions can be provided for an additional fee. I.Q. Auditing works with a network of consultants when a mock inspection or large project requires additional personnel. Please contact I.Q. Auditing for specific pricing and availability.

 

Off-site CGMP / CMC Reviews

Would you like to have a former FDA Senior Reviewer and Lead PAI Inspector review specific documents associated with regulatory submissions, quality procedures, investigations, and/or building plans? I.Q. Auditing will gladly complete these off-site reviews and provide a written analysis for a set hourly fee. Please contact I.Q. Auditing for a free estimate and availability.

 

Contact Info

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All software, web page, and document content, format, functionality, utility, and architecture are proprietary and copyright protected under all applicable laws. IQA maintains all rights, title, and interest in the proprietary software, webpages, and documents including without limitation all patents, copyrights, trade secret rights, trademarks, and other proprietary rights.