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Laboratory Audits: Overview, Guide, and Tips

Laboratory Audits: Overview, Guide, and Tips

Regulatory bodies such as the ISO and the FDA frequently evaluate laboratory operations to check...

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Medical Device Audits: Overview, and Tips

Medical Device Audits: Overview, and Tips

Being a medical devices company, you are well aware of the fact that your products must be made to...

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Corrective and Preventive Action (CAPA) Report

Corrective and Preventive Action (CAPA) Report

CAPA reports are critical in every regulatory inspection for medical devices, pharmaceuticals, and...

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ISO 13485:2016 Audit: Overview, Audit Types and Execution

ISO 13485:2016 Audit: Overview, Audit Types and Execution

ISO 13485 audit provides an objective measure of the organizations’ processes and regulatory...

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Corrective and Preventive Action (CAPA) Procedure

Corrective and Preventive Action (CAPA) Procedure

Corrective and preventive action (CAPA) procedures are critical to the success of the quality...

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What Is CAPA in the Medical Device Industry?

What Is CAPA in the Medical Device Industry?

CAPA consists of a specific set of actions that an organization must complete to resolve and...

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What is CAPA in the Pharmaceutical Industry?

What is CAPA in the Pharmaceutical Industry?

Product quality is a key factor for any pharmaceutical organization and the CAPA process helps...

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Corrective Action and Preventive Action (CAPA) Form

Corrective Action and Preventive Action (CAPA) Form

A CAPA form is a tool used to initiate the CAPA process from different non-conformance events....

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What Is Device Master Record (DMR) and Why Is It Important?

What Is Device Master Record (DMR) and Why Is It Important?

A Device Master Record (DMR) is a collection of all the records that must be used to produce a...

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Design Controls for Medical Devices

Design Controls for Medical Devices

Design Controls indicate that the medical devices your company makes are both safe and efficacious...

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