Equipment validation

Paperless Equipment Validation

If you are using a manual paper-based or hybrid paper/document management approach for equipment qualification, then you are missing the opportunity to centrally control and manage your facilities and achieve substantial global cost and cycle time reductions.  It is impossible to create and maintain a lean streamlined global validation process without the help of technology.  Kneat is a built for purpose e-validation system that enables a best practice process with embedded lean methodologies that can be leveraged across all equipment qualification projects globally.

 

Manage every step of the Equipment Validation life-cycle:

  • Equipment register management
  • Validation master planning
  • Impact assessment
  • Validation project manager
  • Collaborative requirements capture and management
  • Risk assessment
  • Design qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ)
  • Paperless test execution with integrated deviation management
  • Test leveraging based on risk and good documentation practice
  • Periodic review management
  • Change management and re-qualification
  • Decommissioning
  • Part 11/Annex 11 environment

The benefits are many: from cycle time and cost reductions to quality and compliance

  • Productivity Improvement and cycle time savings
  • Standardization across sites becomes the norm, while retaining local site flexibility, where needed
  • Paper records are eliminated – never lose a record and launch any in seconds
  • Potential for data integrity issues minimized, ‘ALCOA’ principles embedded in the process
  • Protocol GDP errors minimized
  • Instant macro and micro visibility into all aspects of the process in real time
  • Query all validation details about every system, its validation review status in real time based on actual work done
  • Audit ready in real time
Client Story:
Tier One Biotech

Digitizing the entire validation life cycle: A productivity leap

The client, a US headquartered tier one biotech with multiple facilities in the US and the EU, achieved productivity improvements of 100% after digitizing validation on the Kneat platform.
Article

Paperless Validation System Versus A Hybrid Paper System

In an effort to enhance consistent quality, address data integrity challenges, reduce costs, and minimize risk, Life Science companies are seeking to optimize their Validation processes. In doing so they naturally consider going paperless and typically look at an existing IT system, before considering a built for purpose paperless validation solution.
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