Paperless Validation

Over the past two decades, there has been much discussion about "paperless" validation. However, the realisation of paperless validation has largely been an elusive goal that has plagued enterprise technology. During the early days of document management system deployment, a key driver of these systems was the promise of the "paperless" office environment.

Finally we are able to carry out our validation testing online. With multi-user collaboration and the ability to autogenerate documents we have seen a 42% reduction in our validation project timelines!

Finally, a comprehensive solution has arrived

Whether you are using the traditional approach to Validation, Commissioning and Qualification or adopting an evolved risk based approach in accordance with ASTM E2500 or someplace in between, Kneat provides a streamlined secure database driven solution.

The Kneat Platform

Our Paperless Validation offering models, automates and manages documentation processes such as:

• Requirements Management
• Dynamic Traceability Matrices
• Risk Management
• Validation Planning
• Document Generation
• Document Review and Approval
• Test Execution and Deviation Management
• Reporting
• Document Change Execution
• Plant Life Cycle Management
• Capability to Replicate Document Sets

Constant Change

Change is constant and each project sees change. With Kneat let your change happen without recreating document sets and reinventing validation. Replicate an existing project and hit the ground running.

Electronic Signatures

Kneat enforces electronic signatures in accordance with regulatory rules for all review, approval and testing workflows. All approved documents and their underlining data elements are subject to change control, audit trail and version management.

Generating and maintaining Requirement Traceability Matrices (RTMs) is a real problem using traditional Word Processing software such as Microsoft Word. Kneat's intelligent table feature allows the prospective creation and maintenance of dynamic traceability matrices, a massive and valuable time saver!

Audit Trails

Kneat's intrinsic, automated audit trail functionality transforms tasks such as reviewing and comparing changes to documentation and modelling structures into simple click-operation. Review operator actions that create, modify, review, approve, and retire documentation; such audit trail data can be accessed at any time in human-readable format and is retained as long as the documents themselves - peace of mind throughout any retention periods making data available to regulators and corporate auditors alike.

Access

Access and permissive control is important to quality safety and efficiency. Kneat provides secure controlled access to users with pre-defined and configurable permission levels. The ability to leverage simultaneous multi-user access to view and edit single documents enables powerful team collaboration, which contributes hugely to efficiencies, something that the traditional check in/check-out systems fail to deliver.

Online Testing

Online testing cuts down dramatically on the paper overhead involved with traditional paper based testing, concentrate on what matters and not the usual administrative red-tape or physical constraints that traditionally surround testing efforts. The power of this tool is really exposed when auto-generating test reports whilst testing is being executed, without Kneat – the report writer would need the paper protocol in order to begin; with Kneat, the data is simply available for use, in real time!

Kneat is a Full Project Solution For

• Requirements Development and Management
• Risk Assessments and Management (FMEA/other)
• Control Strategy Evaluation and Management
• Design Review/Verification
• Stakeholder Communication including Third Parties
• Validation Strategy and Acceptance Criteria
• Validation Testing and Reporting
• Deviation Management
• Project Change Management and On-Going
• Operational Change Control
• System Acceptance and Release
• Powerful Multi-User Environment that Facilitates Easy Collaboration and Concurrent Updates
• Reduction in Diskspace for Mail and Fileservers as a Consequence of Use

Reduce Risk And Overhead

Current systems for creating and maintaining document content are labour intensive, time consuming and susceptible to human error. They have limited capability for automation, collaboration, structured reuse of information or automated change execution.

The quality of change execution being dependent on subjective assessments, and maintaining accurate and consistent documentation is a significant source of risk and overhead, so much so that a high degree of accuracy could rarely be assured.

Kneat Gx has caused the imagination that people can't review the wrong documents, that version control is automatically enforced, nothing gets lost on network shares or local machines and rendition problems no longer exist to be realised. Now the paper work takes the least time, it's fast, accurate and easy!

Compelling Business Benefits

Kneat's Paperless Validation solutions brings a number of key benefits to your business including:

• Reduced business risk
• Lower risk of citations and warning letters
• Lower cost of compliance
• Improved plant performance
• Improved project delivery
• Cloud based architecture – No downtime.
• Cloud based architecture – accessible by all your staff. No more sick days when it snows.
• Cloud based architecture – Backup, Restore, archival and maintenance of backup solutions and associated qualification of this infrastructure is no longer required.
• Perfect solution for distributed and virtual teams.
• Scalable solution. Pay for what you need, when you need it.
• Accessible from any web browser meaning that even in a disaster situation, the documentation for your systems can be accessed and contingency planning is enabled. Currently most companies have their DR plans in the DMS, meaning that in a disaster they can't get their plan.
• Structures can be shared within organisations meaning that global rollouts of enterprise systems can all follow a replicable structure at each site rather than each site running separate projects and reinventing wheels.
• Eliminate wasted time and resources spent on reporting by being able to auto-generate reports and other documents based on the input to previous documentation being executed electronically.

Maintain Data Integrity

Import design data and quickly auto-generate validation test strategies and test protocols. Cloning of work from previous projects leverages the re-use of intelligent lifecycle documents maintaining their embedded relationships. In Kneat, requirements are just text-in-a-table, they are objects with identity, state and behaviour and it is this capability that allows auto-generation of reports and RTMs as well as easy traceability through lifecycle components and test elements.

Leveraging Of Work

Import design data and quickly auto-generate validation test strategies and test protocols. Cloning of work from previous projects leverages the re-use of intelligent lifecycle documents maintaining their embedded relationships.

Paperless Validation - Brochure

If you would like to learn more about our product please click here to the download our Paperless Validation brochure.

If you would like to contact us directly about our Paperless Validation Solutions please use the contact details below.

Email: inquiry@kneat.com
Phone: +353 61 203826