Process validation

Kneat Gx | Paperless Process Validation

Process Validation

Process Validation is the collection and evaluation of data from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering a product.

Process Validation is regulated by FDA  21 CFR 820.75 and 21 CFR Part 211.100, 211.110 and EudraLex Annex 15, and occurs in three main stages, Process Design, Process Qualification and Continued Process Verification. 

 

Stage 1 | Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.

Stage 2 | Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

Stage 3 | Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.

 

There are four key types of process validation, Prospective Validation (before production), Concurrent Validation (during production), Retrospective Validation (after production) and Revalidation (validation following any process change) – all of which can be conducted in Kneat Gx.

Documenting the Process Validation process on paper, can result in significant inefficiencies including an inability to adequately enforce process requirements, non-value-added activities, lack of data visibility, physical record retrieval and storage challenges and lengthy cycle times.

 

 

Kneat Gx | Paperless Process Validation

Kneat Solutions’ next generation paperless validation software “Kneat Gx”, digitizes the entire Process Validation life-cycle, delivering compelling productivity, cycle-time and compliance improvements. 

 

Functions
  • Process Design and DOE (Design of Experiment Studies)
  • Process Qualification
  • Continued Process Verification (maintaining a state of validation)
  • Prospective Validation
  • Retrospective Validation
  • Concurrent Validation
  • Revalidation

Why use Kneat Gx for Process Validation?

  • Risk-based, lean, life-cycle approach to process validation
  • Productivity improvement of up to 100%* and cycle time savings of up to 50%*
  • Eliminates 100% of paper-records, physical storage and retrieval and associated costs
  • Digitized test-execution with integrated deviation management
  • 21 CFR Part 11/EudraLex Annex 11 compliant
  • ‘ALCOA’ Data Integrity best-practice
  • Comprehensive audit trail with detailed, un-editable change log
  • Instant macro and micro visibility into all aspects of the process in real time
  • Protocol based GDP errors minimized
  • System status monitoring – validated, review due/complete, etc.

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