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