Monitoring System Validation


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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.

Validation service for fast deployment

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.

Key Benefits

  • No personnel allocation required
  • Regulatory expertise and proven validation protocols
  • Presentation-quality report documents
  • Cost-efficient and fast service
  • Information and advice provided during visits

Documentation Products

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.

  • The Installation Qualification (IQ) details the steps in the CMS installation, and documents all parameters and variables providing a detailed record of the hardware baseline. The IQ also verifies the presence of the necessary documentation to support ongoing operation of the system, including: relevant SOPs, calibration certificates, and user manuals.

  • The Operation Qualification (OQ) provides evidence that your CMS functions as designed to, and meets the needs of your User Requirements Specification (URS). The OQ tests all GxP-related capabilities of the system, including: audit trails, tamperproof data, and other requirements of 21 CFR Part 11, Annex 11 and PFSB 040122.

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:

  • User Requirements Specification (URS)
    The User Requirements Specification defines the capabilities you have deemed necessary for the Vaisala Continuous Monitoring System to fulfill. This list covers the requirements of a typical continuous monitoring application and allows you to add new requirements according to your needs.
    URS Sample

  • Functional Specification (FS)
    The Functional Specification outlines all functions of the system and can be used by stakeholders to evaluate the CMS as a candidate system by comparison to a User Requirements Specification. Every requirement in the URS is fulfilled by a function in the FS.
    FS Sample

  • Traceability Matrix (TM)
    The Traceability Matrix captures the system requirements through the assessment and testing processes verifying that each requirement from the URS is fulfilled by a corresponding function in the CMS.
    TM Sample

  • Risk Assessment (RA)
    The Risk Assessment outlines all system functions critical to preserving the safety and efficacy of GxP products. This Risk Assessment can be used as justification for the items in the Vaisala CMS that will be tested or not. The RA aligns with a central tenet of GAMP philosophy, which is to leverage supplier involvement.
    RA Sample

Contact Vaisala to discuss more