Digital Supply Chain

Quality and Validation

Automate the entire validation life cycle of the TraceLink Life Sciences Cloud with automatic testing and confirmation to ensure all current TraceLink software capabilities meet GxP compliance in accordance with industry standards such as GAMP 5. More than 1327 companies utilize TraceLink’s purpose-built, network-tenant platform to meet their compliance requirements with the highest quality and most efficient validation procedures at the lowest cost.


  • Significant efficiency and cost savings for hundreds of companies. Eliminate the need for costly validation resources (internal staff or external consultants) to write and execute validation tests manually. For every new release of the TraceLink Life Sciences Cloud, test scripts are executed, results are collated, and a traceability matrix is assembled — all automatically.

  • Operate in a continuously validated state. Never run the risk of having a solution that is not compliant with regulations or trade partner requirements, or waiting to be validated — all of which could delay production or your ability to ship and receive product. Rest assured that the TraceLink Life Sciences Cloud performs as expected across all of your use cases.

  • Functional user interface testing. Receive results from automated tests that provide the objective evidence that the functions within the user interface for different software applications is working as designed and in accordance with the requirements.

  • File transfer testing. Receive results from automated tests that invoke various transactions across each software application. Results ensure that transactions can be received, processed through the mapping layer, and processed by the TraceLink Life Sciences Cloud.

  • Partner integration testing. Leverage TraceLink’s Network Management Services to ensure that partner integrations are sufficiently tested and receive a Partner Integration certificate once all integrations are fully tested and the integration goes live.

  • End-to-end governance with TraceLink’s software development lifecycle (SDLC). TraceLink’s SDLC governs the requirements definition, software specification, and internal testing performed on all TraceLink functionality including the integration of functionality within the system.

  • 24/7 availability of all SDLC documentation. Review materials for every product release remotely or during onsite audits, with Installation Qualification (IQ) and Operational Qualifications (OQ) documents provided for current and historical product releases.


Automated Validation Manager
The only network-tenant validation solution that enables you to quickly adapt to rapid change in a continuously evolving environment. TraceLink Automated Validation Manager eliminates manual, labor intensive, paper-based validation procedures. The only action you need to take is to log in and access your validation certificates.

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