Data Policy & Regulatory Compliance

1. What is Data Integrity ? Data integrity is the assurance that the data is accurate and consistence, and that this assurance has been maintained throughout the data lifecycle. Also data validation is a prerequisite for data integrity. In particular, in the pharmaceutical industry, this is subdivided and explained, so it is good to refer … Read more

After building(constructing) a system (e.g. MES, WMS, LIMS, etc.), the operation plan is very important. If so, I will try to explain how to operate it by imitating the regulations of the pharmaceutical industry. (In particular, the pharmaceutical industry has the most stringent regulations, so it is best to imitate that industry.) 1. Data A. … Read more

Quality Metrics in Regulatory Compliance Quality metrics play a fundamental role in many industries, not just the pharmaceutical industry, and play a pivotal role in evaluating and improving processes, products and services. In the realm of regulatory compliance, these metrics gain even more significance, ensuring safety, efficacy, and consistent quality across products. In this article, … Read more