Document Management

SOPs and other documents need to be managed over their entire lifecycle, from initial creation and review, through to formal usage and final withdrawal.

Life science document management

Effective, fast-access and controlled document management is essential from a regulatory standpoint, as well as organisation efficiency.

Formpipe has developed a well-established platform for case and document management which meets the needs and high-quality standards of the life science industry. Document management is a key part of EQMS solution Platina QMS which covers document, case and training management, as well as compliance and efficient quality management. This ready-to-use document management module offers automatisation capabilities, covering the entire document lifecycle in accordance with regulations and standards adopted by the life science industry, including FDA CFR 21 Part 11 and EU Annex 11.

Regulated life science documents

Regulated document management requires rigid ‘review and approval’ processes (SOP, methods, specifications, etc.). This level of functionality is standard for all documents, document templates, process templates etc. within our product. Approval is easily managed via electronic signatures in a manner compliant with Part 11 and Annex 11.

Version and revision control provides the possibility to track a document’s history and trace all changes made to the document.

Document withdrawal is also available within the document management module in the Platina QMS solution. Removal of documents prevents usage of obsolete or non-applicable documents within the company. The document will continue to exist however in the searchable system for preservation and accessibility for audit purposes.

Production of new documents, document templates, processes, etc. are governed by predefined parameters generated for approval and which are signed with electronic signatures in accordance with FDA CFR 21 Part 11 and EU Annex 11.

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