valMeth Software for assisted Validation of Chemical and Microbiological Methods
Methods validation and Laboratory internal QC

ValMeth is configured as a valid aid for the laboratory for programming, management, reporting of activities related to the validation of internal methods, control of laboratory performance for normed methods and the evaluation of uncertainty measurement.

The “ValMeth” SW is designed for laboratories that act in accordance with EN ISO-IEC 17025: 2005 (Ref. paragr. 4.1.13.1.1, 5.4.2, 5.4.5.2, 5.4.6.2, 5.9.2), and for QC laboratories operating in compliance with GxP.

The software represents a fundamental support for the Laboratory in the activities:

  1. Validation and Verification of Validation of Chemical and Microbiological Standards and Internal Methods:
    • a) Management of Full Methods registry
    • b) Calculation algorithms and creation of graphics of support for:
      • Repeatability
      • Detectability Limit
      • Recovery Rating (if applicable)
      • Accuracy Verify
      • Uncertainty (Metrological Approach) (Confidence Interval for Microbiology)
    • c) Intermediate checks
    • d)  Qualification of Operators checks
  2. Monitoring through Control Charts (Ex. Shewhart, …)
  3. Inter-Lab Circuits (ISO 5725)

The SW also manages :

  • Users Access Profiles
  • Specifications and Performance of Methods
  • Export of the results to other applications (eg. Other LIMS) in formats XLS, TXT, CSV, proposing a “translation table”
  • Also obtained Charts can be saved in bmp, gif, jpeg, wmf, html format
  • This DB methods ensures full traceability of all data and results for users, auditors and inspectors
  • Compliance with 21 CFR Part 11 (Access Control, Audit Trail, Historical Archives, that is unique electronic signature, secure)

”ValMeth”has a Validation Kit which consists of documentation that demonstrates how the product has been designed, developed, reviewed and revised according to a verifiable life cycle.

  • It complies with FDA 21 CFR Part 11 Rules for Electronic Records and Electronic Signature
  • Provides adequate documentation: Functional Specifications, IQ (Installation Qualification), OQ (Operational Qualification).
 
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