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Continuous Monitoring System »
Ensure a high-quality validation of your Continuous Monitoring System and reduce execution time by utilizing Vaisala’s professional services or documentation products.On-site Installation Qualification service captures the baseline configuration of your viewLinc software and assists you in providing evidence of control under GxP guidelines.Operational Qualification provides evidence that your system operates as designed, including all GxP functions: audit trails, tamper-proof data, and the relevant requirements of 21 CFR Part 11, Annex 11 and PFSB 040122.
With proven processes for validating new system installations, upgrades and expansions, we can get you up and running quickly without sacrificing quality.Vaisala will perform a comprehensive Installation and Operation Qualification of your Continuous Monitoring System to help you demonstrate to your auditors that the system has been installed correctly and operates according to the manufacturer's specifications.
IQOQ Documentation Package
If you have the resources to validate your own Continuous Monitoring system, we offer our comprehensive IQOQ protocols as a package to be implemented by your own personnel.
viewLinc 4.3 IQOQ Sample
GxP Documentation Package
The goal of the Good Automated Manufacturing Practice (GAMP) approach is to ensure your monitoring system is fit for use and implemented in a controlled manner through a specification and testing process. The required functions of the system are described in specifications, and then verified. The GxP Documentation Package provides the required specifications, including the typical needs of system owners in regulated markets. The documents can be extended to cover your special requirements.
The GxP Documentation package includes: