GAMP 5 – URS/FRS

Manufacturing and process automation significantly improves quality, productivity, costs, and flexibility in the life sciences industry.  The continued implementation of automation is being driven by the need for greater consistency, reliability, and efficiency in an increasingly dynamic environment.

If quality and efficiency issues are impacting your facility or you would just like to improve quality and efficiency, one approach to ease the burdens of balancing external and internal demands – for example lowering costs without negatively impacting quality – is to focus on validating automated systems.

Whether the focus is on implementing automation into already functioning systems, or purchasing new equipment or systems utilizing automation, Kymanox leverages the Good Automated Manufacturing Practices (GAMP) guidance approach which defines a set of industry best practices to enable compliance to all current regulatory expectations, leveraging your company’s current quality procedures. For this reason, it can be tailored to a number of computer system types without significant impact to current equipment and systems.

We work in concert with users and suppliers so that responsibilities regarding the validation process are understood. For users, GAMP provides a documented assurance, known as User Requirement Specifications (URS) and Functional Requirement Specifications (FRS), that a system is appropriate for the intended use before it goes “live.” We can also ensure that suppliers use GAMP methodologies to test for avoidable defects in the supplied system to ensure quality product leaves the facility.

Kymanox has expertise in all phases of the validation lifecycle, including URS and FRS development, and we take your specific business needs into account while developing the URS and FRS alongside system owners, end-users, and Quality Assurance.

Kymanox ensures efficient and successful qualification by providing engineering and regulatory resources and using an integrated team approach.  System owners and quality units from the client are involved early in qualification planning to ensure that an appropriate level of testing is decided and executed, and that all documentation meets regulatory expectations.  Using a combination of traditional validation methods and risk-based strategies, Kymanox works with each client to ensure robust qualification packages.


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