Life Sciences and Regulated Industries
Companies under Life Sciences can vary from the manufacturing of pharmaceuticals to biotechnology-based food and medicines, medical devices, biomedical technologies, food processing, research and development, etc.
IntellaQuest’s integrated QMS and EHS Management System can help companies operating in Life Sciences while maintaining compliance standards with:
- 21 CFR 820: is a part of the Current Good Manufacturing Practice (CGMP) regulations. It ensures all medical devices created and developed within the US market are safe and follow satisfactory quality processes at all stages of development.
- 21 CFR Part 11: 21 CFR Part 11 states that electronic records and electronic signatures are treated the same as paper records and handwritten signatures. Regulated companies with any documents or records in electronic format must comply with the regulation.
- ISO 13485: is a comprehensive management system specifically for the manufacture of medical devices.
- ICH Q10: TICH Q10 describes one comprehensive approach to an effective pharmaceutical quality system that is based on ISO concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”.
- cGMP: Current Good Manufacturing Practice regulations enforced by the FDA. CGMPs provide systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
IntellaQuest provides a Quality Management System which is a completely integrated single system for Life Sciences enterprise-level QMS. It provides a seamless management of all key needs of a QMS: non-conformance, complaints, CAPA, Document Control, Audit, Supplier Quality, Training, and Management of Control, etc.
The core solution set includes DocuQuest, PeopleQuest, PRRQuest & AuditQuest which help Life Science companies to:
- Eliminate Data Silos
- Optimize their Processes
- Elevate their Customer Focus
- Drive Innovation with Continuous Improvement
- Create mutually beneficial Supplier Relationships
- Leverage data for a factual approach to decision making
Latest Life Sciences and Regulated Industries Articles
ICH Q10: A Modern Framework for Ensuring Pharmaceutical Quality
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.
Pharmaceutical eQMS Software Validation Best Practices
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.
How ISO 14971 Helps Medical Device Firms Better Meet QMS Risk Management Requirements
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.
