When it comes to maintaining compliance, Mesa works hard to offer each of our clients a one stop shop for all of their validation services needs. We make sure that our process is solid in every aspect, including functionality with our DTPro software, and perform validation on our own software to monitor how it performs within our environment. We can use our loggers for the validation process because they meet requirements for validating equipment. This includes protocol generation, IQ/OQ/PQ generation, and performing work onsite using BIs, PCDs and Data Loggers to validate and qualify equipment and processes. Here are a couple of the key features we employ to help customers achieve compliance:
ISO 17025 Compliance Calibration Certification
We have gone through the efforts of making sure that our calibration labs meet or exceed certain standards. These include the stringent calibration standard, ISO 17025, which is required by many clients. Our ISO Compliance Calibration Certificates are fully NIST-traceable, and can reflect up to 17 points of calibration. We offer more points as it helps show that our loggers are well calibrated and meet regulatory requirements.
21 CFR Part 11 Compliance
We provide software that meets regulation requirements, including all regulations for 21 CFR Part 11, the most stringent record keeping requirement. Our loggers meet this requirement straight out of the box, and our manufacturer validation documentation can immediately leverage all of the work that we have put into your loggers to ensure they are regulatory compliant when it comes to 21 CFR Part 11.
Mesa is proud to offer a validation package for DataTrace Pro that allows our customers to leverage all the work we have already done in validating the software. We are also now offering complete validation services to complement many of our products, and have launched a new website detailing this complete offering at validation.mesalabs.com. Check us out today to see how we can help you and your facility get an edge on maintaining compliance.