The pharmaceutical industry is heavily regulated, and ensuring compliance with regulatory requirements is crucial for maintaining product quality, safety, and efficacy. One critical regulation is 21 CFR Part 11, which governs electronic records, electronic signatures, and electronic systems in pharmaceutical manufacturing. In this blog, we’ll delve into the world of 21 CFR Part 11 compliance….
In recent years, the USFDA focuses on data integrity resulting in a rise in 483 observations and warning letters being issued for data integrity violations. These violations can have serious consequences, including regulatory action, legal consequences, damage to the company’s reputation, and financial losses. Moreover, the FDA has the authority to recall drugs if they…
After defining which business processes are cGxP relevant the next phase is to map them in detail. The following steps are performed: A. Identify the systems (both paper and electronic) involved in the processing of cGxP data B. Define individual cGxP data elements C. Identify cGxP data elements that can be modified, deleted, or…
When assessing data integrity risks within an organisation, companies may focus immediately on those systems or areas that are the most obvious in this context, such as a particular software, a specific lab system or instrument etc. Doing so creates the risk of forgetting less visible but still important areas, processes or systems, or…
GMPs are minimum requirements that companies must meet in the development and execution of acceptable procedures for pharma manufacturingprocesses – from hygienic practices of employees and their work environments, to record keeping to how to handle returns and overages to specifications and testing of in-process and finished products. Data integrity plays a key role…
Data integrity is the accuracy, completeness, and consistency of data across its lifecycle. It is essential for making informed decisions, ensuring compliance, and preventing errors and fraud. However, data integrity can be compromised by humanerrors, malicious attacks, system failures, or poor data management practices. Artificial Intelligence Integrity (AII) is a set of practices that…
ALCOA+ is an acronym that stands for Attributable, Legible, Contemporaneous, Original, Accurate, and the ‘+’ refers to Complete, Consistent, Enduring, and Available. These principles form a critical checklist to ensure that data is trustworthy and reliable. Here’s a brief overview: By embracing the ALCOA+ principles, organisations can significantly enhance their data integrity assurance,…
