case study

Updating 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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Updating 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.

RCA understood our needs and helped design a CAPA process that aligns with industry best practices and takes us to the next level.

 

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.

 

About RCA

capaRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

 

To begin the RCA® 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.

RCA understood our needs and helped design a CAPA process that aligns with industry best practices and takes us to the next level.

 

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.

 

About RCA

capaRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

 

To begin the RCA® 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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