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Software Validation

EIS 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 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:
Develop and follow a validation path
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Perform an in-depth risk assessment
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Properly documented user requirements and functional design
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Testing 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:

Functionality

Usability

Reliability

Performance

Supportability

 
 
EIS-Logo

North America

Enhanced Information Solutions Inc.

1725 Tower Drive, Suite 100 Stillwater, MN 55082

Europe

E.I.S. GmbH.

Besselstrase 25

68219 Mannheim, Germany

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