The DocuShare Compliance Module provides a solution for managing controlled documents generated for businesses subject to governmental regulations. The module extends core Docushare functionality in areas crucial to demonstrating regulatory compliance. In addition, the module adds Electronic Signature functionality to Docushare, and fully complies with the technical provisions of 21 CFR Part 11.
The validation package provided with the Compliance Module—Validation Master Plan, Requirements, Design, and Test, and Template IQ & OQ—reduces the effort associated with systems validation for most organizations.
The Compliance Module enhances Docushare security to provide secure electronic signatures on controlled objects.
PDF’s are digitally signed so that any alteration is detected.
Docushare security, enhanced with the Compliance Module, prevents unauthorized alteration or removal of controlled documents.
The Compliance Module’s enhanced audit trail captures the client machine where the action was initiated.
A signature page is rendered with each controlled document, showing all attached signatures.
The Compliance Module’s electronic signature functionality cryptographically links each signature to its source document.
The Compliance Module’s electronic signature functionality requires the Docushare user to supply username & password in order to electronically sign a document.
Provided via standard Docushare functionality; Docushare ensures uniqueness of each user ID.
The DocuShare Compliance Module provides regulated organizations with the ability to implement electronic document, content, and records management with compliance processes fully in place. Download the datasheet.
Details
Industry:
any Regulated Industry, such as Pharmaceutical/ Life Sciences, Financial, Energy, Healthcare and others
Available:
2006
Category:
All
Contact:
Bryan Reynolds
Address: 700 Alexander Park
Suite 302
Princeton, N.J 08540
Sitrof Technologies is a unique consulting company formed in 1999. Sitrof’s management teams, architects, developers and technicians have helped companies of all sizes implement effective document and records management systems in pharmaceutical, state government, banking and insurance. Sitrof uses its experience to deploy solutions that solve content management issues critical to the success of companies. See DocuShare Compliance Module and www.sitrof.com.
