Product Hub: Metrohm – NIR spectroscopy and compliance
To ensure drug quality, powerful analytical instruments such as spectrometers are used for production monitoring.
Software that helps you adhere to pharma regulation
The use of these instruments underlies regulations, which extend to the associated software. The FDA lays down guidelines for software use in regulated industries in CFR Part 11, which concern electronic signatures and user management, as well as records and audit trails. If these are followed, electronic records have many advantages over paper-based ones, including cost savings, increased data security, and improved accuracy. Metrohm’s Vision Air is developed specifically to enable users from the pharmaceutical industry to keep electronic records in line with CFR Part 11…