Quality Document Management
QualityExpert™ includes Quality Document Management System (QDMS) for life sciences companies, supporting full set of capabilities including authoring, review, approval, distribution, tracking, storage, access, controlled printing and reporting.
Benefits
Standardization
Establish common standards through pre-configured documents
Unified Processes
Harmonize the document management processes in the quality domain
Content Management
Manage, reuse and control quality related content throughout their life cycle
Version Control
Document edition, control and implementation
Where Used
Impact assessment analysis
Collaboration
Cross-functional collaborative features
Single source of Truth
Quality documentation asset repository, single source of truth
Quality documentation management includes:
- SOP management (includes Quality Manual, Policies and Guidelines, as well as training documentation)
- Quality Control documentation management
- Technical agreement management
- Validation documentation management
- Product Quality Review management
- Site Master File management
QualityExpert™ QDMS enables:
- Using controlled templates for all quality-related documents – from high-level policies and guidelines, through process specific instructions and procedures to lower level records
- Predefined workflows, metadata, versioning policies, roles and permissions
- Document management for quality assurance, quality control, manufacturing and R&D including SOPs, analytical procedures, flow charts, working instructions, specifications etc.
- Content reuse for internal and external purposes (e.g. same product information being used in laboratories and in a technical agreement or contract)
- Controlled printing with the use of additional overlays for offline track record
- Periodic review and document validation processes, including automatic notifications
- Automatic document expiration notifications to responsible users
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