ICH Q10 is a revolutionary quality management framework specifically tailored for the pharmaceutical industry, ensuring product quality throughout its lifecycle. This modern approach focuses on continuous improvement, risk-based methodologies, and streamlined processes to maintain product safety, efficacy, and reliability. As a comprehensive and harmonized standard, ICH Q10 is crucial in fostering a culture of pharmaceutical quality, benefiting both manufacturers and consumers alike.

As part of different regulatory requirements for pharmaceutical industry standards, the eQMS software needs to comply with several quality specifications and regulatory requirements for US FDA Title 21 CFR Part 11 Electronic Records and Electronic Signatures guidelines, US FDA Title 21 CFR Part 820 Document Controls guidelines, EU Annex 11 Computerized Systems guidelines, ISO 13485:2016 Control of Documents and Control of Records guidelines, and other GMP guidelines. As a result, the Computerized System Validation (CSV) is the prime requirement for any Pharmaceutical eQMS Software. To help pharmaceutical industry with this validation process, IntellaQuest incorporates the complete validation service along with its eQMS software package and quality consultancy.

In the rapidly evolving world of medical device manufacturing, ensuring the safety and efficacy of products is of paramount importance. Manufacturers face a multitude of regulatory requirements designed to minimize risks to patients and healthcare providers while promoting innovation. Among these standards, ISO 14971 and ISO/TR 24971 play a crucial role in guiding medical device manufacturers through the process of risk management, and they play an important role in the implementation of a QMS that meets the requirements of ISO 13485. In this article, we will delve into the importance of ISO 14971, explore the complementary role of ISO/TR 24971, and discuss their applications in the medical device industry.