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

Related content

Discover our Life Sciences solutions

Connect with us today!