vLog VL software for validation/mapping of GxP environments The vLog system is the most accurate and effective solution for understanding your environments and complying with regulations. With easy set-up and placement of self- contained data loggers, you can be mapping a chamber in minutes. vLog has multiple file security features that aid in regulatory compliance, including: Security status of the data is identified on every report Each time data is downloaded, vLog generates a unique checksum value, which is the Logger File ID number. File ID numbers are referenced in: logger file creation reports, data logger files, trend graphs, tabular data, all printed reports ASSESSMENT OF VAISALA VLOG VALIDATION SYSTEM COMPLIANCE TO 21 CFR PART 11 REQUIREMENTS Contact us VLOG BROCHURE MAPPING SERVICE Vaisala vLog is a powerful validation/mapping software for downloading, analyzing and reporting information from Vaisala data loggers. The software is easy to use and designed for performing temperature and humidity mapping studies in GxP-compliant applications. The software includes calibration tracking for the sensors to ensure study results are reliable. The optional IQ/OQ protocol document ensures that vLog software operates with integrity, security and reliability.For non-regulated, standalone data logging, we offer vLog SP software for basic trending and analysis.Vaisala mapping service is currently available in Great Britain, Europe, and Japan. Features Security Control:Three levels of security to control access:Windows, domain level, and local account authentication. File Security for Regulatory Compliance:Security status of the data is identified on every report to aid in compliance with for 21 CFR Part 11 and Annex 11. System-wide Traceability:Built-in audit trail gives secure reports for time periods specified by users. No interaction with the system goes unrecorded. Easy Data Transfer:Copy and paste or export graphs, .TXT and .CSV files into other Windows and/or database applications. Key benefits High quality reporting Display temperature, humidity and other parameters on single or separate graphs. Create standard and customized documents fast, including statistics such as min, max and average values, mean kinetic temperature and other calculations, or export to spreadsheets for further analysis. Easy to use and reliable Simply place the data loggers where you need them — no wires to handle. All DL-series loggers are equipped with a 10-year battery, large internal memory, and stable sensors. vLog lets you focus on study results and analysis, rather than time-consuming setup and re-calibrations. Data integrity With vLog’s validated audit trail, no interaction with the system goes unrecorded. Data is secure and tamper-proof, and always gap-free to ensure studies are compliant with 21 CFR Part 11. Product documentation Docs.vaisala.com More downloads Application Note: 21 CFR Part 11 compliance for environmental monitoring: Software functions Vs. operating procedures (808.45 KB) Application Note: 8 Steps to Better Chamber Validation Project (232.08 KB) Infographic: 9 Steps Mapping Infographic (307.97 KB) Brochure: vLog Validation System Brochure (310.27 KB) Manual: vLog 4.5 User's Guide EN (3.02 MB) Pagination Next page ›› Product Resources Customer case Commissioning, Qualification & Validation: Fundamental for pharmaceutical products & life-saving therapies Operating a GxP facility that must comply with regulatory requirements is no simple matter but doing so ensures that products are manufactured and delivered safely under meticulous regulation and standards. Learn more Customer case Easy and accurate validation system ensures competitive advantages to mapping service provider Since 1988, Performance Validation (PV) has provided validation, commissioning, and quality services to pharmaceutical, biotechnology and medical device manufacturing and distribution. Learn more Webinar Mapping made easy: where to place sensors & why This webinar will provide 5 simple rules for mapping studies to effectively determine sensor placement. Senior Regulatory Expert, Paul Daniel, will review the regulations and industry guidance on mapping along with discussing a validation method to reduce the total number of sensors required while maintaining your study’s defensibility under audit. Learn more
Application Note: 21 CFR Part 11 compliance for environmental monitoring: Software functions Vs. operating procedures (808.45 KB) Application Note: 8 Steps to Better Chamber Validation Project (232.08 KB) Infographic: 9 Steps Mapping Infographic (307.97 KB) Brochure: vLog Validation System Brochure (310.27 KB) Manual: vLog 4.5 User's Guide EN (3.02 MB) Pagination Next page ››