What is quality and manufacturing document management for Life Sciences
Life sciences companies must conform to strict health authority regulations in all product manufacturing processes. This includes strict management and governance of related content, which is generally created by Research and Development, routed to various teams for review and approval and submitted to health authorities for initial approval. The content is then handed over to Manufacturing, who may create additional content and ensure adequate maintenance of these documents. The processes for creating, maintaining, revising and training on these documents must be carefully controlled based on current Good Manufacturing Practices (GMP).
OpenText Documentum for Quality and Manufacturing features
Fast, efficient authoring
Streamline the creation, review, approval and change management of documents governing manufacturing, quality, compliance and other processes across the extended enterprise.
Document change management
Simplify the periodic review and change request processes to strike a balance between flexibility and control that reduces training requirements and increases adoption.
Automate document distribution
Release and automatically send "Read and Understood" actions with enhanced training records retention.
Support the technical transfer process
Seamlessly transfer documents between the regulatory and quality domains in a single step while providing document traceability.
Maintain data across entire lifecycle
Maintain connection at the product level and harmonize data with OpenText™ Documentum™ for Research and Development to cover the full product lifecycle from development to manufacturing.
Multiple deployment options
Choose the deployment model, cloud, managed services or on-premises, that makes sense for the organization, while ensuring security, privacy and control requirements are met.
Benefits of OpenText Documentum for Quality and Manufacturing
Increase flexibility and control
Predefined, yet flexible, business rules streamline creation, approval, change control and retrieval of quality and manufacturing documents.
Improve realtime visibility
Easily demonstrate compliance with access control, detailed audit trails, e-approvals and e-signatures. Gain insight on day-to-day performance around the globe.
Provide seamless content sharing
Eliminate unnecessarily importing and exporting content from one system to another with a single authoritative source that manages clinical, regulatory and quality content and processes.
Contact us to speak with a member of the Life Sciences team
- Documentum for Quality and Manufacturing data sheet
- The way forward: Innovation in life sciences quality management white paper