While the use of custom developed applications is declining due to the use of configurable off-the-shelf (COTS) software applications the use of Service Oriented Architecture (SOA) and middleware in the Life Sciences industry demands a cost effective and specific approach to validation.

Custom Applications Validation

Leveraging accelerators from their unique Validation Library, Business & Decision's computer system validation consultants support Life Sciences organizations to validate their custom software (sometimes still known as bespoke software) applications and help software vendors to develop and 'pre-validate' their products., making it easier for regulated users to leverage supplier quality activities and streamline their own validation efforts.

Risk-based validation is used throughout, assessing the impact on product quality and patient safety to assure appropriate return on investment.

Service Oriented Architecture Validation and Middleware Validation

Life Sciences companies are increasingly looking to use SOA and Middleware to interface regulatory significant COTS applications or to develop unique business processes, often managing regulatory significant data.

Extending well established principles of risk-based software validation and IT Infrastructure qualification, Business & Decision has developed a unique, cost-effective approach to the validation of Service Oriented Architectures and middleware, allowing Life Sciences organizations to use the latest technology, ensure business process excellence and assure regulatory compliance.

Read our Pharmaceutical Engineering Article on SOA Verification

Click on the "Controlling SOA in Support of Operational Improvement" link to the right (under "See our publications") to read our recently published article on the cost effective, risk-based verification of middleware and Service Oriented Architecture.

Written by Business & Decision Life Sciences' David Stokes, the article was published in the July/August 2011 (Vol. 31, No. 4) edition of ISPE's Pharmaceutical Engineering and provides the outline of a structured approach to the qualification and validation of middleware and SOA, based on work conducted with a number of pharmaceutical clients.

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