PerkinElmer Syngistix Automated Method Validation
Validation of analytical methods is a requirement for many types of labs and is a critical step as these labs seek to obtain national or
international accreditation. The challenge is in satisfying regulatory compliance while significantly improving data traceability. An example of
such regulatory need for method validation is in USP Chapter <233>, which specifies the various tests that a lab should conduct to validate
an ICP-MS method for the analysis of elemental impurities in pharmaceutical products.
Manual method validation is time-consuming and prone to errors, negatively impacting productivity. PerkinElmer’s Syngistix™ Automated
Method Validation module, an extension of Syngistix for ICP-MS software and NexION® ICP-MS instruments, is designed to eliminate
inefficiencies by streamlining the workflow and avoiding potential human error of traditional method validation.
The Syngistix Automated Method Validation module replaces traditional paper-based method validation where technical data resides in
protocols, notebooks, forms, unprotected spreadsheets, and technical reports. By centralizing all instrument validation data, this improves
data traceability and integrity. If installed along with Syngistix for ICP-MS Enhanced Security™ software, the user access control, audit trail,
and electronic signatures functions are provided, helping the lab comply with 21 CFR Part 11.
The Syngistix Automated Method Validation module streamlines your method validation and improves compliance by eliminating transcription
errors, delivering data traceability and reducing process inefficiencies.
www.geicp.com Glass Expansion Newsletter | Issue 46 7