Analytical Method Validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical results. In the past, this has traditionally been managed using paper-based documentation.

Of course, there are many challenges in using traditional paper-based cleaning validation:

  • In the manual process, islands of information are lost in a sea of paper documents, databases and file folders
  • Lack of visibility when it comes to data and the validation status
  • Delays and errors caused by paper-based validation documents and protocol execution
  • Risk assessment is not available as integrated process with validation
  • Inability to manage and maintain periodic reviews and parameter changes
  • Lack of efficient knowledge management due to islands of data
  • Analytical Method Validation activities and documentation are not integrated with lab instruments to fetch data for input directly into protocols
  • All data analysis must be manually written/typed in paper-based protocols
  • Analysis results from lab instruments must be physically printed and attached as part of evidence

Automated Analytical Method Validation

The ValGenesis VLMS automates the Analytical Method Validation lifecycle by integrating lab instruments directly into the validation protocols.

  • Analytical Method Validation Master Plan and validation procedures created and approved in ValGenesis VLMS drive all method validation deliverables and requirements
  • ValGenesis VLMS helps to determine and conduct the design and development of protocols, as well as the execution and approval of protocols, using the electronic protocol execution with objective evidences
  • Both PC- and Non-PC-based lab instruments can be integrated with the ValGenesis VLMS
  • Parser templates are mapped to the Analytical Method Protocol specification to dynamically parse the data from the raw data files generated by instruments
  • Generate sample IDs and labels that can be tracked via lab instruments, with sample results directly captured in the protocol
  • Storage of primary files for future review, received from lab instruments as part of inbuilt Scientific Data Management system
  • A risk-assessment-based approach to identifying the number of samples to be taken for Analytical Method qualification
  • All validation deliverables are electronically created, reviewed and approved, eliminating paper from the validation process
  • Our VLMS provides real-time information on the validation statuses of your products
  • Electronically perform trend analysis as part of validation reports, as well as annual product quality reports and analysis of method parameters
  • Analytical Method Validation is fully integrated with cleaning and process validation processes
  • Store primary data from lab instruments as part of the Scientific Data Management system available in ValGenesis

Analytical Method Validation

Advantages of Digitizing the Analytical Method Validation Process:

ValGenesis VLMS enables total visibility, across multiple sites for Analytical Method Validation lifecycle.

  • 100% electronic approach to the Analytical Method Validation lifecycle, in compliance to 21 CFR Part 11 & data integrity requirements
  • Significantly reduced analytical method validation cycle time and cost
  • Improved consistency and data integrity
  • Elimination of non-value-added activities
  • Increased levels of compliance
  • More accurate tracking of changes and approvals
  • Full control of access to all instrument/equipment data, documentation, protocols and batch records
  • Real-time access to analytical method validation status information

Resources

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Press Releases

Leading Global R&D-Based Pharmaceutical Company Chooses ValGenesis’s VLMS to Manage Validation Process
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