Validation of analytical methods is a requirement for many types of labs and method validation is a critical step as these labs seek to obtain accreditation. The challenge is in satisfying regulatory compliance while significantly improving data traceability.
Manual processes of validating methods are time-consuming and prone to errors, which negatively impacts productivity. The Syngistix™ Automated Method Validation application module, an extension of our Syngistix for ICP-MS software and NexION® ICP-MS instruments, is designed to eliminate process inefficiencies by streamlining the workflow and avoiding potential human error faced in traditional ICP-MS method validation.
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The Syngistix Automated Method Validation software module replaces the traditional paper-based analytical method validation process where technical data resides in protocols, notebooks, forms, unprotected spreadsheets, and technical reports. By centralizing all of the instrument validation data, this improves data traceability and integrity. And 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. Electronic signatures allow reviewers and approvers to digitally sign the validation reports.
The Automated Method Validation module successfully streamlines your method validation practices and improves compliance by eliminating transcription errors, providing data traceability and reducing process inefficiencies.
Advantages of the Syngistix Automated Method Validation solution include:
| 产品组 | Software and Informatics |
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