Automate

Automation is at the heart of efficiency.

Kneat Gx is designed to automate where possible and enable intelligently where automation is not possible or desirable. Key automation features include:

1. Document generation
Kneat has developed a novel approach which automates life cycle document generation, management and change. Kneat Gx generates documents from the underlying data elements and automates the creation of complex documentation such as:

2. Document review and approval
Kneat Gx allows you to configure flexible workflow which models your current approach to review and approval. User’s comments are captured online and all stakeholders can view each other’s comments in real time, eliminating the need for printing paper copies.

3. Change requests to approved documents and the associated workflow and change execution
Approved information is protected. Kneat’s configurable tools allow the automation of your specific change execution requirements. If a user tries to modify any aspect of an approved document, (be it data, text or complete sections), he is routed through an automated change control process with robust version management and audit trail. The audit trail includes full details of each change made to all affected document sections and is designed in accordance with FDA 21CFR Part 11 regulations.

4. Change request impact and risk assessment
As part of change request pre-approval Kneat Gx performs an impact assessment on all life cycle documents. This assessment identifies all sections of all documents which will be affected if the proposed change request is implemented. It presents the before and the after view of every affected section of all life cycle documents. It facilitates the preparation of retest protocols to verify the proposed changes. When the stakeholders are directed to the change request for approval they clearly see what will change, its impact and how it will be re-tested.

5. Updating of affected documentation based on closed out deviation /change request
When the change request is post approved all the views of every affected section of all the life cycle documents are updated automatically with the latest information. This powerful functionality ensures your documentation is always accurate and up-to-date.