Compliance & Governance

       

Compliance & Governance

The Challenge

Your business is subjected to more compliance and regulation than ever before. New data breach laws apply to virtually all Asutralian businesses. You must comply or face significant fines

The Solution

We provide a practical solution that helps organisations and related businesses fulfill the documentation requirements associated with quality regulations, compliance and standards. Standards and regulations such as ISO 9001, FDA 21 CFR Part 11, EU GMP Annex 11, HIPAA and SarbanesOxley, set certain requirements for document management that can be easily met.

Download Information


Key Features
eSigning

With the eSigning & Compliance extension, you can maintain compliance with regulations such as FDA 21 CFR Part 11 and EU GMP Annex 11 more easily than ever.

Assignments

Assignt and track tasks to individuals or groups, including managed deadlines to ensure completion

Electronic Approval & Process Workflows

Build efficiencies by using Workflows for approval or other business processes to electronically route and keep track of documents through every step of the process.

Audit Trail for Audits

Make compliance audits a breeze by simply giving your auditors access to the system. They will be able to quickly access all compliance check information digitally, saving you countless hours in traditional audit preparation.

Key Benefits
Traceability

Every step of the process is tracked and auditable

Latest Information

Always work off the latest version

Training

Competency management for strict process control

Security

Metadata driven permissions make compliant security easy to implement and maintain