Microsoft SharePoint is a very powerful platform that has significantly reduced the market access point, in terms of time and cost, to implement a paperless document management system. However, the standard SharePoint platform is not immediately or fully ready to be compliant with some regulations that are applicable to Pharmaceuticals, with a special reference to 21 CFR part 11 (Electronic Record and Signature).
K2C has developed all required add-on to be fully compliant with these regulations, here including a pre-defined set of powerfull features to electronically sign and easily manage the critical documents and records.
K2Pharma EDMS Module includes the following features:
• Management of Company document templates, predefined but fully configurable by users
Management of Metadata associated with a document category (you may define some metadata as “mandatory” to
facilitate the identification and any future retrieval )
• Possibility to create and manage composite documents, made of many "child" documents
• Management of Content Organizer rules for uploading, downloading and destination folders
• Access rights fully configurable at any level, for area, department, process, document type and/or single document
• Retention and security Policy fully customizable by users for any document category or content type.
• Automatic management of document coding, according to desired standard.
• Versioning, version history and audit trail
• Many tools including search, document conversion, custom definition of views and reports etc.
Contact us for more information or to request for a demo.