Whitepaper: Regulatory compliance in pharma – software requirements and solutions

In this whitepaper, Metrohm discuss the standardisation organisations put forward for analytical instruments requirements with a focus on software…

The prosperity of a society can be evaluated based on many criteria, and the focus is certainly different for each individual. However, the factor everybody will unhesitatingly agree with is health.

When sick, we can nowadays fall back on high performing, high quality drugs. To ensure this good quality, powerful analytical instruments such as spectrometers are typically used to monitor their production. Standardisation organisations put forward requirements for the use of these instruments. These requirements, with a focus on those concerning software, are presented in this white paper.

General overview CFR Part 11

Records and signatures in regulated environments can be either created on paper or electronically. In the past, the use of paper has been favored over electronic records and signatures. Advantages of electronic records compared to paper-based records are cost savings due to a reduced need for personnel to manage and maintain the files, an increase in data security, and as well improved accuracy