Business & Decision Life Sciences’ consultants are experts in the field of validating custom developed applications in the increasingly important field of validating service-oriented architecture (SOA) and middleware based applications.
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.
Leveraging accelerators from their unique validation library, Business & Decision Life Sciences’ 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. This makes 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.
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 Life Sciences 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.
Published in ISPE Pharmaceutical Engineering (Vol 31 No 4 - July/August 2011), our article "Controlling SOA in Support of Operational Improvement" discusses an approach to the cost effective and compliant qualification and validation of Middleware and SOA. This has formed the basis of a number of strategic approaches developed with our clients.
To download a copy of the article see "Download Related Publications" to the right
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