validation.mesalabs.comMesa Labs Validation Solutions

Skip to content 12100 West 6th Ave. Lakewood, CO 80228 303.987.8000 customerservice@mesalabs.com Facebook page opens in new window Twitter page opens in new window YouTube page opens in new window Linkedin page opens in new window Website page opens in new window Mesa Labs Validation Validation Solutions Validation Services IQ/OQ/PQ Services & Documentation Warehouse Mapping Temperature Mapping Equipment Qualification & Calibration Process Control Validation Consulting & Assessment SOP Development Equipment Temperature Control Units Autoclaves/Steam Sterilizers Lyophilizer/Freeze Dryer Clean Rooms/Controlled Environments Depyrogenation Ovens & Tunnels Other Mesa Products Capabilities Documents & Resources Blog Contact Us Search: Validation Services IQ/OQ/PQ Services & Documentation Warehouse Mapping Temperature Mapping Equipment Qualification & Calibration Process Control Validation Consulting & Assessment SOP Development Equipment Temperature Control Units Autoclaves/Steam Sterilizers Lyophilizer/Freeze Dryer Clean Rooms/Controlled Environments Depyrogenation Ovens & Tunnels Other Mesa Products Capabilities Documents & Resources Blog Contact Us 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. LEARN MORE Autoclave Depyrogenation Oven Lyophilizer Temperature Control Units Clean Room What impact does the HVAC system have on your warehouse hot spots? Does a change in airflow impact temperature equilibrium across the warehouse? What impact does the changing weather have on certain areas of the warehouse and how does that change throughout the year? Mesa will work with you and your team to look into every variable that may impact the viability of your product. LEARN MORE Mesa Global Services can provide IQ, OQ, IOQ, or PQ protocols to fit your validation needs. Our experience in the validation field allows us to create highly-customizable documents that will meet all of your design, product, company, and regulatory requirements. LEARN MORE Mesa can provide guidance for manufacturers working to meet the requirements of the FDA Code of Federal Regulations Title 21, Sections 820.70 and 820.75. Our staff is well versed in these regulations and we have the experience and expertise to assist in the planning and execution of the controls and procedures that need to be implemented. LEARN MORE From initial design to process qualification, Mesa is the ideal partner for GxP manufacturing consultation and support. Our relationship and participation within regulatory organizations globally offers Mesa the advantage of being able to stay on top of vital changes effecting our customers within the regulatory community. Our processes are highly scrutinized and we bring that same attention to detail to your processes and to your equipment. LEARN MORE At Mesa Labs, our sample Standard Operating Procedure (SOP) templates are written by engineers and product specialists, allowing the end user to customize the SOP to meet their unique needs. LEARN MORE Previous tab Next tab 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. Mesa’s OQ protocols will: Demonstrate and document that the equipment operates within predetermined limits when used under defined operating procedures. Test and record the operation of equipment security systems, sequence of operations, all modes of operation to meet user requirements, equipment alarms and interlocks, and any other specific requirements of the equipment. Document the verification of any applicable equipment parameters, sensors, switches, control devices, logic circuits, gauges, and any preventative maintenance requirements. Mesa’s PQ protocols will: Verify that the equipment, previously verified to be installed and operational per user requirements, is able to consistently perform in accordance with the predetermined acceptance criteria. Verify and document the equipment can operate consistently and repeatedly under normal, less than optimal, and worst case conditions. Verify the alarm and interlock functionality under operational conditions. Previous tab Next tab Equipment we Validate Temperature Control Units Autoclaves/Steam Sterilizers Lyophilizers/ Freeze Dryers Clean Rooms/ Controlled Environments Depyrogenation Ovens & Tunnels Start managing your risk today Contact Us 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. Learn More 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. Temperat...