Continuous monitoring system validation Ensure a high quality validation of your monitoring system and reduce system implementation time by using our expertise and understanding of GxP quality systems. Vaisala offers on-site Installation Qualification (IQ) and Operational Qualification (OQ) services. The IQ captures the baseline configuration of your system and provides evidence of control that aligns with GxP guidelines. The OQ provides evidence that your monitoring system is operating as designed, encompassing all GxP functions of the system, including audit trails, tamper-proof data, and the relevant requirements of 21 CFR Part 11, EU GMP Annex 11 and PSFB 040122. Contact sales Contact helpdesk Key Benefits Economical and efficient Monitoring system validation by a skilled Vaisala technician is an economical choice, providing a significant savings in time and resources. Let us take care of the IQ/OQ system validation so that you can concentrate on your core business. The quickest way to audit-ready monitoring Our understanding of GxP regulations and quality system standards in life science industries allows us to validate the viewLinc continuous monitoring system expertly. The service ensures that your system is validated, documented, and ready for regulatory scrutiny. Comprehensive validation documents Validation service includes full documentation to demonstrate that the system operates correctly and meets quality standards and regulatory guidance. Customer quote: “We set an aggressive timeline to get the system operational. Our original plan was to switch our facilities over completely to Vaisala’s system and devices by July 2013. We met that objective because Vaisala was able to support the effort with installation, validation and technical support.” Joe Cwiertniewicz, McKesson Facilities Manager Read full story Product documentation Docs.vaisala.com More downloads Brochure: Continuous Monitoring System Validation Solutions Documentation and Services for GAMP/GxP Compliance Simplicity (900.49 KB) Regulatory Compliance Information: Using GAMP5 methods to validate your continuous monitoring system software (1020.92 KB) Brochure: viewLinc Continuous Monitoring System Services Brochure (2.14 MB) Related Products & Applications Webinar How to validate system software according to GAMP principles Watch now Infographic GAMP validation of continuous monitoring systems View infographic Application note A GAMP-based approach to validation Learn more
Brochure: Continuous Monitoring System Validation Solutions Documentation and Services for GAMP/GxP Compliance Simplicity (900.49 KB) Regulatory Compliance Information: Using GAMP5 methods to validate your continuous monitoring system software (1020.92 KB) Brochure: viewLinc Continuous Monitoring System Services Brochure (2.14 MB)
