Every validation team knows the drill: the same requirement, copy-pasted across a dozen documents. The same test case, retyped and re-formatted for every new system. The same trace matrix, rebuilt by hand every time an auditor asks for it.
Document-based validation — on paper, Excel, SharePoint, or "paper-on-glass" software — is far too inefficient for teams to tackle more systems without more help.
VLMcare breaks validation into its functional parts. Requirements, risks, and tests are re-usable objects. Build a requirement once, and reuse it across every system, protocol, and project it applies to. Update it once, and every linked object updates with it.
In this live product demonstration, we'll show exactly how that works. And we'll do it all in about 20 minutes.
What you'll see
- How requirements, risk assessments, and test cases are built as standalone, linked objects
- Reusing and recombining validation objects across systems and protocols
- Real-time, auto-generated traceability
- Audit-ready reporting
- Execution of test protocols
Meet your presenters
Speakers
Jeff Ramos
Software Implementation & Service Delivery Lead, VLMcare
8 years in digital validation, with prior experience at ValGenesis before joining the VLMcare team. Jeff runs hands-on demos daily for validation teams evaluating a move off paper-based and document-centric systems.
Randy J. George
Area Director, North America, VLMcare
Randy brings extensive experience helping pharmaceutical and biotechnology organizations navigate complex regulatory and technology challenges. He is also active in professional life sciences organizations and industry networking.