case study

CAPA Processes & Preventative Action

A leading developer and manufacturer of affordable, high-quality generic pharmaceuticals, wanted to improve their system for corrective and preventive action (CAPA). They implemented RCA’s recommended SOP and improved CAPAs in their software tool.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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CAPA Processes & Preventative Action

Background

Qualitest, a leading developer and manufacturer of affordable, high-quality generic pharmaceuticals, wanted to improve their CAPA processes for corrective and preventive action.

Solution

Qualitest engaged Regulatory Compliance Associates® Inc. (RCA) to improve their CAPA System. RCA brought a wealth of knowledge by providing tools, advice and best practices for incorporation into the new draft standard operating procedure (SOP) and CAPA system.

Result

Qualitest is implementing the new SOP and capturing CAPAs in their software tool which collects and analyzes data. The company plans to pursue CAPA certification after obtaining new equipment for the automated software system.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Background

Qualitest, a leading developer and manufacturer of affordable, high-quality generic pharmaceuticals, wanted to improve their CAPA processes for corrective and preventive action.

Solution

Qualitest engaged Regulatory Compliance Associates® Inc. (RCA) to improve their CAPA System. RCA brought a wealth of knowledge by providing tools, advice and best practices for incorporation into the new draft standard operating procedure (SOP) and CAPA system.

Result

Qualitest is implementing the new SOP and capturing CAPAs in their software tool which collects and analyzes data. The company plans to pursue CAPA certification after obtaining new equipment for the automated software system.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

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