ECM EDMS

Electronic Document Management - K2Pharma

 

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.

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