Documents
The Documentation functionality provides a simple Document Management process. It enables a simple workflow to create, approve and upload documentation with version control. Documents have associated Due by and Review By dates, to provide visible tracking and reminders for documents where regular Compliance reviews are required, eg. SOP’s.
Any type of document ranging from standard word processing to spreadsheets to Project gantt charts, to images and videos can be loaded into the system, with no limits on size.
Change Control on documents ensures that Changes are made in a controlled manner.
- Example Plans: Validation Master Plan, Project/Quality Plan, Installation Qualification Plan
- Example Specifications: Product, Component, Raw Material, Packaging, Labelling, etc.
- Example Design document: General Facility Design, Process Design, System and Equipment Design
- Example Qualification Protocols: Installation, Operational and Performance Qualification, System Acceptance Test Specifications, Factory Acceptance Test Specifications
- Example Reports: Quality Report, Validation Report, Qualification Report, Supplier Report
- Example Technical/Equipment documents: Technical Manual, Guide, Instructions, User Manual and Guides, Training Materials and Presentation
- Example Certificates: Training Certificates, Calibration Certificates, Certificates of Conformance.
- Example Computer System Validation Documents: User Requirements Specification, Functional Specification, Software Design Specification, System Integration Test Specification.
The Alert system will ensure that the owners of outstanding Documents are alerted, prior to completion date to ensure timely response to outstanding actions.
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