HLIMS / TRUST CENTER
Validation, security and implementation.
Plan the evidence and responsibilities needed to evaluate HLIMS for your intended use.
01Validation documentation
Define the required IQ/OQ/PQ deliverables, requirements traceability, audit-trail descriptions, signature controls and change-control documentation for the selected product version and implementation scope.
02Security and deployment
Review hosting locations, access controls, encryption, backup, recovery and service-provider responsibilities for your proposed deployment.
03Evaluate against your intended use
Assess product capability, configuration and laboratory procedures together. Agree the technical specification and validation responsibilities before acceptance.