Pharma QMS Solution | Pharmaceutical Quality Management Software

Importance of Quality Management System (QMS) in the Pharmaceutical Industry

Over the past few years, the global pharmaceutical market has experienced drastic changes, forcing pharmaceutical companies to focus on customer needs and upon their own internal efficiency to ensure quality and compliance throughout the pharmaceutical demand chain.

Pharmaceutical quality experts are facing challenges, and have opportunities to improve quality and compliance. Complex supply chains, mergers and acquisitions, data integrity problems, and increasing regulations are all forces that impact pharmaceutical quality strategies and processes daily.

Besides, the FDA and other regulatory bodies such as Good Manufacturing Practice (GMP) and EN ISO 9001 Quality Management System (QMS) are focused not only on the importance of building a culture of quality management but on compliance in the pharmaceutical industry.

Pharmaceutical companies are required to determine and keep a quality control unit for their quality management under 21 CFR Part 211. A crucial part of a pharmaceutical quality management system is documentation (SOPs, procedures, policies, etc.) and controlling them to influence product safety and quality.

Additionally, pharmaceutical companies also comply with 21 CFR Part 11, the FDA guideline that applies to all FDA- governed industries for electronic records and electronic signatures, ensuring their authenticity and reliability, while being as comprehensive as paper records. A pharmaceutical quality management system should cover these key aspects of Part 11: audit logs & tracking, the guidelines and rules for storage, copying, access & permissions, version control of the electronic records, and electronic signatures application.