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Document Management

Document control is foundational in the management of quality, compliance, safety and risk. You must be able access and share the correct information immediately from a central, electronic location – and in a form that is easily understood. This is now an everyday business task and essential during internal, external and customer audits.

Through the Document Control module, we introduced an electronic document distribution procedure, and its acknowledgement feature was great for giving us visibility on who had received and read each document – meeting the auditor’s criteria.

Salmah Mahmood, Head of Quality at Anthony Nolan

Eliminate the paper chase and provide access to important documents anytime, anywhere

Our document management solutions address the complete document management lifecycle, including all actions and notifications associated with:

  • Creation and Approval
  • Review and Change Requests
  • Publishing and Distribution
  • Storage in Document Registers
  • Reporting and Visibility of the Document
  • Management Process
  • Policy-related Training and Competency Management

These important functions are automated by the Action and Workflow engine eliminating the paper chase.

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Virtual folders provide quick access to live or draft documents within the system.

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Integration with Audit, CA/PA, Reporting and Competency functions
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Clear view of actions and notifications associated with overall document lifecycle
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Mobile: View, read and acknowledge documents on the move
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Electronic signature ability, compliant with 21 CFR, Part 11and FDA requirements
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Statement of Applicability solutions links regulations to internal controls

Reinforcement and Demonstrate Regulatory Compliance

Our compliance management solutions provide a Statement of Applicability function that allows you to map the clauses of a regulation or standard directly to documents such as policies, procedures or other system entities such as risks. This strengthens and helps you communicate your compliance to staff, internal and external auditors and regulatory authorities. There is no better way to begin an external audit than to hand over your statement of applicability to the auditor.

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