Companies and organizations that operate in highly regulated industries have particularly high demands on document management in relation to other industries that can cope with a more standardized document management (FormPipe Document Management). With this difference taken into consideration, FormPipe Software has developed functionalities that meet the high quality standards within the Life Science industry.
FormPipe Life Science and Document Management for Life Science meet all conditions for a strict quality information management.
It requires 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.
As for FormPipe SOP Management & Training, the person who initiates a "Review and Approval" process is the one to set the conditions for the process such as date, features, etc. Approval is managed via electronic signature.
Within FormPipe Document Management for Life Science, there is also functionality for deleting records. For such activity to be done, a process is automatically initiated that involves approval from document owners and administrators. The document will continue to exist in a searchable system for preservation. To create new documents, document templates, processes, etc. such processes governed by predefined parameters are generated for approval and are signed with electronic signatures in accordance with FDA CFR 21 Part 11 and EU Annex 11.
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