Document Management System

All documents are categorized by assigning them to three high-level groups

Documents are categorized by assigning them to one of three levels: strategic, master, and specific.

Strategic documents deal with the company’s own strategy or policies.

Examples:

  • Site master files
  • Master validation plans
  • Master hygiene plans
  • Organization charts

Master documents deal with general organizational, administrative, or technical tasks. They describe and guide the quality assurance system and standardized procedures within the company. Master documents can also contain information on general methods that are not specific to a particular product or device.

Examples:

  • SOPs (e.g. deviations, change control management, CAPA, training, OOS/OOT)

Specific documents are instructions for specific products or devices. They include detailed descriptions of specific procedures.

Examples:

  • Work instructions, test procedures
  • Manufacturing instructions and records
  • Control instructions and records
  • Validation protocols and reports
The document structure can be depicted as a pyramid

The document management system helps us efficiently monitor our business processes

The main objectives of our document management system are to establish, check, monitor, and record all activities that directly or indirectly affect any aspect of the quality of medicinal products in compliance with GMP requirements.

The document management system ensures correct drafting, workflow, approval procedures, withdrawal of documents, and archiving.

The document management system was developed by a specialist in GMP-regulated U.S. and European applications.

What does the document management system support?

  • Document management and training

Which control procedures does the document management system support?

  • CAPA management
  • Change control management
  • Deviation management
  • Complaint management
  • OOS procedures