Data Integrity Work Shop

I attended a work shop on Data Integrity; this is a very challenging area for majority of pharma companies, these challenges vary from company to company. This is also a major area of focus for the regulatory bodies. Embedding data integrity in pharmaceutical QMS not only instils complete confidence in pharmaceutical products by the end […]

Data Integrity: Asset or Liability

Data Integrity: Asset or Liability   Introduction Data integrity (DI) is fundamental in any pharmaceutical quality system; this ensures that medicines are of the required quality, safety and efficacy. Data integrity refers to the overall completeness, accuracy and consistency of data during its entire life cycle.  The data lifecycle considers the entire phases in the […]

The Importance of Data Integrity in Pharmaceutical Quality Management System

  The Importance of Data Integrity in Pharmaceutical Quality Management System The MHRA (2015) states  “Data integrity (DI) is fundamental in a pharmaceutical  quality  management system which ensures that medicines are of the required quality and the data governance system should be integral to the pharmaceutical quality system described in EU GMP chapter 1.” Furthermore […]