Audit Compliance
Case Studies / Solutions / Audit Compliance
Audit Compliance
Document management System
Our DMS solution allows classifying, managing and archiving of documents. Audited approvals provide traceability to document management and archiving.
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.
