Electronic Document Management Solutions

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.