Computer System Validation (GAMP®5)

GAMP® was founded in 1991 in the United Kingdom to deal with the evolving U.S. Food and Drug Administration expectations for Good Manufacturing Practice(GMP) compliance of manufacturing and related systems. GAMP® published its first guidance in 1994. Soon afterwards the organization entered into a partnership with ISPE, formally becoming part of ISPE in 2000. GAMP® has enjoyed the support of numerous regulatory authorities over the years spanning the United States, Europe, and Japan and is now a recognised good practice worldwide.

GAMP®5 is a registered Trademark of the International Society of Pharmaceutical Engineering.

GAMP®5, published in 2008, provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. It points to the future of computer systems compliance by focussing on principles behind major industry developments such as PQLI; ICH Q8, Q9, Q10; and ASTM E2500.

The Guide addresses the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. It contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.

 

During the operational life of a GxP system, regulators usually focus on the integrity, consistency, and completeness of controls required to maintain compliance (Compliance Controls). This Guide also highlights the importance of the operational phase of the system lifecycle, when the return on investment for the significant time and resource expended in implementing new computerized systems can be achieved. The Guide helps regulated organizations achieve regulated computerized systems that are fit for intended use and compliant with applicable regulations and provides comprehensive guidance for maintaining control of regulated systems throughout their operational life.

 

The General Principles of Software Validation (FDA 2002) defines Validation as "Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled".

The software validation guideline states: “The software development process should be sufficiently well planned, controlled, and documented to detect and correct unexpected results from software changes." Annex 11 states "The validation documentation and reports should cover the relevant steps of the life cycle."

 
 

 



     
     

Customer References

  • I can certainly recommend Compliance Control as experts in this field and they will add value and deliver on your project. CFO, Major Pharma Company
  • Compliance Controls Consultants brought immediate expertise to our team as part of our drive into the European market. Vice President, Research & Development, Pharma Company
  • We wanted an organization with proven experience ensuring our organization can meet EU regulatory requirements. Business Development Manager, Phama Company
  • I would like to personally express my great appreciation for all your excellent work and great support with the validation of our IT infrastructure and software. Managing Director, Compounding Centre, UK
  • ComplianceControl Centre was selected because it is easy to use, quick to set up, and was a validated, cost effective solution for an organization of our size. We wanted a system that we could rapidly implement. Vice President, Research & Development, Pharma Company
  • Working with Compliance Control Consultants and their software products ComplianceControl Centre and cGARD helped us to understand the regulatory requirements of IT and business systems more clearly. IT Director, Pharma company
  • Using ComplianceControl Centre will help us to ensure that we are always inspection ready, by tracking our critical Quality and Compliance activities. Vice President, Research & Development, Pharma Company
  • It has been a pleasure working with you and your team and I am looking forward to co-operating with your company on similar projects in the future. Managing Director Compounding Centre UK
  • Based on your achievements and delivered results, we have started the process of building up our internal team for continuation of the work started by you. Managing Director, Pharma Company
  • cGARD has become the new rage here ! Sr. Manager, Documentation and Training, Major Pharma Company

 

 

    

 




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