The software validation process required to meet global standards and regulations can be complex, time-consuming, and costly. We can make the process easier, faster, and more cost-effective.
If your laboratory operates in a regulated environment, you may be required to validate your software. Global standards (e.g., GLP, GCP, GMP) and country-specific regulations (e.g., US FDA 21 CFR Part 11, Annex 11) require validation of electronic, record-keeping systems to ensure their accuracy, reliability, and consistent performance, as well as to ensure each system's ability to identify altered or invalid records. Our on-site validation services can help you meet these requirements and reduce your compliance risk.