SOPs and other documents need to be managed over their entire life cycle, from initial creation and review to formal usage and final withdrawal.
Performing effective and safe document management, and having fast and controlled access to them, is essential not only from a regulatory standpoint but also in terms of organization efficiency.
Taking the high demands and regulatory requirements in consideration, Formpipe has developed the already well established platform for case- and document management to meet the needs and high quality standards specific to the Life Science industry.
Document management is a key part of the flexible and modern EQMS solution Platina QMS which meet all conditions for compliance and efficient quality management, covering both document, case- and training management. This ready-to-use document management module provides automatization capabilities covering the entire document life cycle in accordance with regulations and standards adopted by the Life Science industry, such as FDA CFR 21 Part 11 and EU Annex 11.
Regulated document management requires among other things a rigid "Review and Approval" process for business critical documents and templates (SOP, Methods, Specifications, etc.). In our product such functionality is standard for all documents, document templates, process templates etc. 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 yet another example of functionality within the Document Management module in the Platina QMS solution. Removal of documents prevent usage of obsolete or not applicable documents within the organzation. The document will though continue to exist in the searchable system for preservation and accessibility for audit purposes.
Creation 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.