In an FDA-regulated environment such as the life sciences market, software validation is paramount to compliance. While documentation – and sometimes lots of it – is a standard by-product of a validation effort, the sheer volume of paperwork does not guarantee a fully-validated system. EIS has years of experience on numerous projects in varying roles. This has provided our staff with the ability to navigate any software development & implementation project through the sometimes difficult validation terrain.
EIS is fully versed in industry best practices for software validation, such as GAMP5 (Good Automated Manufacturing Practices) and FDA Guidance documents. Using all GAMP phases helps guide any project through the necessary steps toward a validated system. Developing a Validation Plan, User Requirements and a Risk Assessment results in a detailed, more comprehensive set of system specifications. Functional Design, Acceptance Criteria, Test Specifications and Protocols help make sure the product that will ultimately be delivered is functional, as bug-free as possible and meets the needs of the end-user.
Steps for a successful validation system: