Regulated Documents

Benefits

  • Compliance with legislation applicable to regulated industries and organizations
  • Standardization of documents and processes  
  • Intended for all types of regulated information content and for their entire lifecycle
  • Extended security control and content auditing

Document Management in Compliance with Regulations

Pharmaceutical companies, scientific centers, financial service, power industry and government agencies are the entities governed by strict regulatory rules. These regulations exactly specify when and under what circumstances electronic documents can be authored, modified, approved, published and archived. Entities operating in the industries requiring compliance with the regulatory rules must fully integrate the compliance into their processes as efficiently as possible.  The aim is to reduce the risk for both the company and users of its products and services, as well as achieving the competitive advantage - for example for assurance of product availability on the market in the shortest possible time.

The Regulated Documents solution, primary idea of which first occurred in strictly regulated pharmaceutical environment, represents logical extension of the Document Management services. Modern technologies guarantee maximal content demonstrability, strict standardization, and control of process procedures while maintaining the efficiency of the operations.

Regulated Documents – Product Characteristics:

  • Management of all documents for their entire lifecycle  
  • Compliance with all Good Practice regulations (SxP – GxP)
  • Integrated electronic signature functionality for forms and workflow
  • Document content stored in a high-performance, scalable repository
  • Access rights security assurance through 9-level security model
  • Automated and controlled document numbering
  • Support of content categorization through metadata and taxanomic classification
  • The solution offers a great number of collaboration tools
  • Intuitive integration with desktop applications as for example Microsoft Office or Adobe Acrobat

The solution is suitable for all business areas.

References:

  • Walmark