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Phone: 651-351-9227
info@eisincorporated.com
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Software Validation
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 the use of software industry best practices, 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
that the product which will ultimately be delivered is functional, as
bug-free as possible and meets the needs of the end-user.
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.
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