How does validation work? DQ, IQ, OQ, PQ - this is not what you want to read here again and again. Just about every school of thought relative to validation includes the standard approach of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Validation is very often seen as additional extra-work without any added value. In our opinion and understanding Validation is the normal operational result of Good Engineering and Project Management Practices. Validation needs to be totally integrated into the Quality Management System and the project planning & execution manual - policies and procedures for good practice. For the methodology of Project Management, System Development, Engineering, and IT Management refer to recognized standards like PMBOK, Prince2, ISO 12207, ISPE GAMP and Good Practice Guides, CMMI, Scrum or ITIL, and we choose the right strategy and extent for your business needs. We are recognized subject matter experts for ISPE GAMP®5 and ASTM E2500. 

The so called risk-based approach will be based on a Quality Risk Management concept, refer to ICH Q9. A scalable approach to validation can be achieved by analysing and ranking risks, which will guide through the validation and project process.

On the other hand validation planning and execution required smart documentation templates and processes. The usage of electronic tools for document management, requirements engineering, development work-flow tools, source code handling, and test management should be clearly defined and implemented.

We work with different tools and applications from our project partners to make such a risk-based and integrated approach happen - a systematic process for identifying, assessing, mitigating, controlling, and communicating risks. Open CCS validation model.

Quality and Compliance Management can provide the necessary framework for implementing quality by design. Clients with a robust quality system and appropriate process knowledge can implement many types of improvements. In addition, an effective quality system, by lowering the risk of manufacturing problems, may result in shorter and fewer inspections. Several key concepts are critical for any discussion of modern quality systems. Quality by design means designing and developing a product and associated manufacturing processes that will be used during product development to ensure that the product consistently attains a predefined quality at the end of the manufacturing process. Quality by design, in conjunction with a quality system, provides a sound framework for the transfer of product knowledge and process understanding from drug development to the commercial manufacturing processes and for post-development changes and optimization.

How to implement an effective quality system and making quality happen? Contact us today to find out more about our 21 CFR Part 11 and validated eQMS solution based on MS SharePoint, including electronic signatures, audit trail and security functions: This e-mail address is being protected from spambots. You need JavaScript enabled to view it  

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GAMP is a registered trademark of the ISPE - International Society for Pharmaceutical Engineering Inc.