TraceLink announced Automated Validation Manager (AVM), a web-based offering that automates the validation lifecycle of the TraceLink Life Sciences Cloud on an ongoing basis.
When customers subscribe to TraceLink AVM, they no longer have to deploy manual paper-based validation procedures and their current instance of the Life Sciences Cloud is automatically validated to meet GxP compliance requirements in accordance with industry standards, such as GAMP 5. TraceLink AVM customers login to a web portal and review any aspect of the validation lifecycle, including the validation plan, traceability matrix, test results and final validation certificates. Once validation is complete, TraceLink AVM customers will know that all required IQ, OQ, and PQ test scripts have been successfully executed in a dedicated validation environment.
“We introduced our network-tenant Life Sciences Cloud platform in 2009 as a revolutionary architecture that would enable life sciences companies in any geographic market to eliminate the risks associated with frequent technology updates resulting from continuously changing laws, data exchange requirements and trade partner demands,” Shabbir Dahod, president and CEO of TraceLink said. “Automated Validation Manager is the next step in managing the complexity of computer systems validation for our customers, ensuring that they have an easy-to-use solution that removes the business and operational burdens of manual validation and keeps them continuously compliant.”
TraceLink AVM removes the in-house and outsourcing burdens of validation by automating validation testing and confirming that current TraceLink software capabilities perform as intended. The end result is a fully executed, 100% paperless package compliant with GxP compliance standards, such as GAMP 5.