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Audit Compliance

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Document management System

Our DMS solution allows classifying, managing and archiving of documents. Audited approvals provide traceability to document management and archiving.

audit compliance

Key Features

  • The framework allows the classifying, managing and archiving of documents based on a classification and directory structure.
  • This classification is specific to the scenario such as clinical trials in pharmaceuticals research, insurance claims etc.
  • The scanned documents with attachments are uploaded by the end user and moved into the correct classification.
  • The framework is based on SAP Portals, Java WebDynpro and Adobe Forms.
  • Product Safety, medical enquiries, complaint management, incidence reporting, CAPA, drug tracking and tracing, ePedigree, lot tracking.
  • Compliance and Validation across all processes (21 CFR Part 11, xGMP).

SAP Release Requirements

  • SAP NetWeaver 04s / 7.0 / 7.1.
  • SAP Java WebDynpro.
  • SAP Adobe Interactive Forms.
  • SAP CAF / SAP BPM.

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