case study

Designing a CAPA System

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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Designing a CAPA System

Background

Qualitest, a leading developer and manufacturer of affordable, high-quality generic pharmaceuticals, wanted to improve their CAPA system 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

CAPA systemMaintaining data integrity is an important part in ensuring the manufacturing quality of pharmaceuticals. It is crucial in current good manufacturing practices (cGMP), and employees should have the experience and knowledge to properly record and handle data—in order to eliminate any data integrity issues.

Regulatory Compliance Associates® Inc. offers offers both training and consulting solutions to meet any organizations needs. Our services include:

Training:

  • Good Documentation Practices (GDP) Centered on How the Data is Recorded, How to Correct an Error, and How to Document the Reason(s) for the Error
  • Current Good Manufacturing Practice (GMP) Regulations
  • Investigations
  • Corrective Action and Preventive Action (CAPA)

Consulting:

  • Comprehensive Audits
  • Development of a Remediation Plan
  • Risks and Weaknesses Identified During the Audit
  • Assistance with Execution of the Remediation Plan

 

Background

Qualitest, a leading developer and manufacturer of affordable, high-quality generic pharmaceuticals, wanted to improve their CAPA system 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

CAPA systemMaintaining data integrity is an important part in ensuring the manufacturing quality of pharmaceuticals. It is crucial in current good manufacturing practices (cGMP), and employees should have the experience and knowledge to properly record and handle data—in order to eliminate any data integrity issues.

Regulatory Compliance Associates® Inc. offers offers both training and consulting solutions to meet any organizations needs. Our services include:

Training:

  • Good Documentation Practices (GDP) Centered on How the Data is Recorded, How to Correct an Error, and How to Document the Reason(s) for the Error
  • Current Good Manufacturing Practice (GMP) Regulations
  • Investigations
  • Corrective Action and Preventive Action (CAPA)

Consulting:

  • Comprehensive Audits
  • Development of a Remediation Plan
  • Risks and Weaknesses Identified During the Audit
  • Assistance with Execution of the Remediation Plan

 

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