The Top 7 Benefits of the Audits according to the FDA.

In this article, you will learn what are the main benefits of the audits according to the FDA requirements and cGMP Good Manufacturing Practices.

All quality audit brings important benefits including, but not limited to:

1. compare your documented quality management procedures versus real-world practices at the company.
2. locate deficiencies in quality management processes.
3. flag potentially serious issues that can lead to non-compliance penalties.
4. identify potential opportunities to eliminate waste (a key facet of lean manufacturing).
5. initiate corrective and preventive actions (CAPA) and remediation of nonconformances.
6. verify that your CAPA has been completed effectively and on time.
7. recommend ways to further optimize your company’s quality management and compliance practices to lower the cost of quality.

In theory, the audit will prevent quality system failure before it occurs.

It will save time, reduce costs, and keep an operation running efficiently and productively.

Since audit management can be very challenging, especially for industries with many inspections.

Therefore, exists different audit software to help organize and carry out all audit needs.

CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

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Three (3) Options to Create Document Control Management DCM Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the Document Control Management DCM procedure templates in .pdf format. 

To see the complete list of the most popular quality procedures templates, click here.

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill, and adapt to your specific needs.

Silver Option. We Can Bring You Formal Training about the benefits of the audits.

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality Procedures.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.

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REFERENCES: The main benefits of the audits.

STATUTORY AND REGULATORY REQUIREMENTS

TITLE 21–FOOD AND DRUGS

PART 820 Medical Devices

820.22 Quality audit. Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.22

2 CFR § 200.501 – Audit requirements

httpss://www.law.cornell.edu/cfr/text/2/200.501

For more information about the benefits of the audits, refer to:

httpss://www.intertek.com/auditing/gmp/

httpss://haccpmentor.com/gmp/gmp-audit/

httpss://ispe.org/initiatives/regulatory-resources/gmp/audit-considerations

httpss://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap

httpss://www.fda.gov/media/90179/download

httpss://www.orielstat.com/blog/what-is-mdsap-certification/

httpss://www.bsigroup.com/en-US/medical-devices/Our-services/Medical-Device-Single-Audit-Program/

httpss://www.tuvsud.com/en-us/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-single-audit-program-mdsap