12100 West 6th Ave. Lakewood, CO 80228 303.987.8000 customerservice@mesalabs.com Mesa Labs Validation Validation Solutions Validation Services Equipment Capabilities Documents & Resources Blog Contact Us Search: Validation Services Take the pain out of compliance In 2017, the FDA issued 5,155 warning letters & 420 product recalls Don’t become part of the statistics Optimizing Your Temperature Monitoring System Learn the best practices for making your temperature mapping system as efficient and accurate as possible with our handy Temperature Mapping Do’s and Don’ts Guide We help you … Address pain points Resolve deficiencies & citations Ensure regulatory compliance Maintain defensible audit trails With qualification & validation Assure quality & reliability Reduce recurring costs Mitigate risk Why Mesa? We’ve been designing and manufacturing a wide range of quality control instruments for over 30 years and by building them ourselves, we’ve gained a deep understanding of validation, calibration, and compliance. Few companies today have such comprehensive experience and knowledge of critical monitoring processes and how to make them meet operating regulatory guidelines. With Mesa, you’ve got a trusted partner with three decades of experience supporting you! Trusted by the world’s leading brands … Our Services IQ/OQ/PQ Services & Documentation Warehouse Mapping Equipment Qualification & Calibration Process Control Validation Consulting & Assessment SOP Development With Mesa’s Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols and services, you can be assured that your equipment has been validated and is ready for use. Autoclave Depyrogenation Oven Lyophilizer Temperature Control Units Clean Room Types of Validation Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Mesa’s IQ protocols will: Record critical information applicable to the equipment, including equipment attributes such as the manufacturer, serial number, model number, equipment tag or asset number, materials of construction, and the location where the equipment will be installed. Record the system instrument and valve information, including the manufacturer, model number, materials of construction, and calibration information (if applicable). Verify the required utilities for the equipment, such as electrical, process gases, and/or steam. Verify documentation specific to the equipment, such as P&IDs, operation and maintenance manuals, purchase orders, component specifications, lubricants, equipment safety features, and the required spare parts. Equipment we Validate Temperature Control Units Autoclaves/Steam Sterilizers Lyophilizers/ Freeze Dryers Clean Rooms/ Controlled Environments Start managing your risk today Case Study: Crab Processing See how Mesa Labs was able to assure compliance for a client in their crab cooking process with our highly accurate DataTrace MPRF data loggers. Recent Articles Temperature Mapping for Summer Months As the summer months approach, you may need to begin thinking about having your product storage areas temperature mapped. Warehouses should be temperature mapped during both the hottest and coldest times of the year to ensure that the items being stored are being kept at optimal conditions year-round. Mapping storage areas in the summer months… Details How Mesa Labs Validates DTPro Software DTPro Software revisions may occasionally be needed to add functionality, fix issues, or remove obsolete aspects. To ensure that our updates meet FDA 21 CFR Part 11 and our own requirements, the software validation effort is a tightly controlled process. Major updates to the DTPro Software require that the software specifications be revised. These specifications… Details Validating with DataTrace DataTrace data loggers and DTPro software can be used to record and analyze temperature, humidity, and pressure data for numerous applications. The most common uses for DataTrace data loggers and DTPro software are mapping storage and laboratory equipment, sterilizers, and cooking processes for qualification/validation efforts or routine process monitoring. Temperature Data Loggers are used to… Details 3 Stages of Validation – Stage 3 There are three stages of the validation process that will help to make sure that your product, process, service, or system meets industry requirements, user specifications, and is able to fulfill its intended purpose. The final step in the validation process is Performance Qualification (PQ). Mesa’s PQ protocols will: Verify that the equipment, previously verified… Details Featured Articles FDA 503B Compliance February 22, 2017 Applying Specialty Pharmacy Regulations When Working with Partners or Contracted Organizations December 15, 2016 Why are Specialty Drugs and Specialty Pharmacies “Special”? December 8, 2016 About Us Corporate Site Terms & Conditions Contact Mesa Laboratories, Inc. 12100 West 6th Ave. Lakewood, CO 80228 303.987.8000 customerservice@mesalabs.com Find us on: © 2016 Mesa Labs, Inc. All rights reserved. Notice We and selected third parties use cookies or similar technologies for technical purposes and, with your consent, for other purposes as specified in the cookie policy. With respect to advertising, we and selected third parties, may use precise geolocation data and actively scan device characteristics for identification in order to store and/or access information on a device and process personal data like your usage data for the following purposes: personalized ads and content, ad and content measurement, audience insights and product development. You can freely give, deny, or withdraw your consent at any time by accessing the advertising preferences panel. You can consent to the use of such technologies by closing this notice, by scrolling this page, by interacting with any link or button outside of this notice or by continuing to browse otherwise. Learn more and customize Accept ×