End-to-end Equipment Validation, Computer System Validation etc. Make the Validation process structured, easier to perform and easier to manage.  Configure a streamlined, paperless and transparent process for all Validation types – Equipment, Instrument, Computer, Cleaning, Process, Method, etc.

The Kneat e-Val Solution

The Kneat e-Val solution enables business process innovation, delivering compelling productivity, cycle time and compliance improvements.  All your validation process can be set up on the system making it structured, controlled, compliant, centrally managed and paper free.

The result of using Kneat Gx is best practice processes that can be leveraged over and over globally across your company:

  • Enabling users to be more productive and compliant as they do their work.
  • Providing management unprecedented visibility and control of all areas of the process.
  • Providing a real tool to drive down capital and operational costs, minimize compliance risk and ensure audit readiness.
Increase productivity and reduce cycle times using Kneat e-Validation.
Using the Kneat e-platform you can optimize all your asset lifecycle stages from design through verification through ongoing change and final decommissioning. The Kneat software has been developed from the ground-up with robust electronic record electronic signature capabilities. Using Kneat you can create an electronic streamlined process for all your asset Validation Lifecycle Management such as:

• Validation Register Management

• Manufacturing Equipment, Systems, Utilities Validation

• Computer System Validation

• Laboratory Equipment Validation

• Process Validation

• Cleaning Validation

• Cleaning Monitoring

• Method Validation

• Periodic Review management – alerts and instant visibility

• System Status Monitoring – Validated, Periodic Review Due/Complete, etc.

Kneat is passionate about maintaining your processes, facilities and systems in a state of control
Good Manufacturing Practice requires that you build and operate manufacturing processes that are suitable for purpose, that will consistently deliver therapeutic products that meet their pre-defined Quality Attributes. Amongst many other activities this requires that you design, build and validate your Facilities, Utilities, and Equipment (FUE) to ensure that they meet their design intent with an overriding focus on product quality and patient safety. A structured repeatable Validation process helps to deliver many benefits such as

• Shorter less challenging start ups

• Shorter time to peak facility performance

• Faster time to market

• Higher quality

• Make Compliance effort easier

• Audit readiness

Kneat Gx Overcomes Validation Process Challenges:
The Kneat e-platform enables a robust structured templated process that can be leveraged over and over. Finally, standardisation can be the norm where best practice can be centrally created and leveraged globally. Some of the Challenges that Kneat Gx can help to overcome are:

• Removing paper records

• Designing and embedding a Lean process is difficult when using a paper/hybrid process

• Very difficult to standardize and leverage best practice across projects/ sites and also allow for controlled flexibility where it may be needed

• Record handling, management and storage is time consuming and requires significant coordination. Records get misplaced.

• Review and Approval is cumbersome even in good document management systems

• Inefficient and GDP error prone test execution and summary reporting

• Metrics not readily available leading to more difficulty for management

• Difficult to access the right data quickly

• Difficult to search for and retrieve Information

• Poor Management visibility into the process at site/ multi-site level

• Data integrity concerns i.e. adhering to ‘ALCOA’ principles

• Meeting critical path system lifecycle activities

 

An e-Validation process can be easily and quickly configured on the platform and no coding is needed.  Our customers are reporting compelling ROIs based on real productivity, cycle time improvements leading to greater product throughput and to a higher compliance standard.

Our software is allowing them to optimize their Validation and GxP testing globally and to become totally paperless.

Kneat Gx is proven to deliver business value and to scale efficiently across global sites.

Key feedback from our customers is Kneat Gx’s ease of use, its ease of deployment and its ease of scalability to new processes and to new global sites.