Software ValidationEIS is fully versed in industry best practices for software validation
Ensuring Compliance through Software Validation
In an FDA-regulated environment such as the life sciences industry, 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:
Develop and follow a validation plan
Perform an in-depth risk assessment
Properly document user requirements and functional design
Test with comprehensive protocols and test plans
One major key to success is involving the validation effort in all aspects of software development, not just documentation and testing. In addition to doing as much as possible to ensure that a software product is bug-free, the software must also do what it is intended to do. Using a broader approach, EIS software validation addresses five key aspects: (1) Functionality, (2) Usability, (3) Reliability, (4) Performance and (5) Supportability. This fits in with our overall business model because it helps deliver a quality software product, makes sure the customer/end-user is satisfied and ensures a long-term business relationship.
Our validation approach meets all the requirements for: