QMS Software for Pharmaceuticals

A pharmaceutical quality management system is a comprehensive framework that encompasses all of the processes, procedures and tasks necessary for achieving and maintaining product quality and regulatory compliance. QMS tasks necessary in pharmaceuticals production run the quality control and assurance gamut, from risk management to equipment calibration to continuous improvement.

Pharma manufacturers are faced with numerous regulatory standards, from the most basic, such as General Manufacturing Practice (GMP) to the more specific, such as ISO 15378, which focuses on pharmaceutical packaging materials. The most-used pharmaceutical quality standards and regulatory guidelines include:

• FDA 21 CFR Part 211
• FDA 21 CFR Part 210
• ISO 9001:2015
• ISO 17025
• GMP
• ICH Q10
• EU Annex 11

Maintaining a comprehensive quality management system is a requirement for bringing pharmaceuticals to market in most countries, including the United States, Canada and abroad. Documentation of these compliance efforts is necessary at all stages of pharmaceutical development, testing, manufacturing and distribution. Meeting these standards is a complex undertaking, but the major elements involve:

• Ensuring appropriate qualifications of personnel
• Properly maintaining equipment and facilities
• Controlling components, product containers and closures
• Production and process controls
• Packaging and labeling controls
• Proper storage and distribution
• Laboratory controls
• Maintaining appropriate records and reports

QMS software (eQMS) helps simplify all aspects of the quality management process by automating workflows to ensure all procedures are followed, managing documentation and approvals, ensuring suppliers adopt quality and risk management processes, utilizing real time data and providing built-in transparency and traceability.

With an eQMS, pharmaceutical companies achieve easier, more accurate regulatory compliance, enhanced product quality, as well as more easily mitigate risk, ensure patient safety and foster continuous improvement.

QT9 QMS offers an end-to-end solution for addressing the challenges of compliance and quality management in the pharmaceutical industry. QT9 QMS offers more than 25 modules that come standard, including:

• Document Control
• Risk Management
• Audit Management
• Employee Training
• Supplier Management
• Management Review
• Calibration Management

QT9 also offers the ability for pharmaceutical companies to create electronic Batch Records (EBR) and electronic Master Batch Records (MBR) with one click using a simple QT9 QMS and QT9 ERP integration. Take advantage of QT9’s free validation and a dedicated compliance portal for securely sharing records with auditors.

QT9 QMS is a fully validated, highly rated eQMS that is cost effective, easy to use and offers full customer support, an available ERP integration and Business Intelligence tool. QT9’s user-friendly interface and no-nonsense licensing lets pharmaceutical companies focus on getting quality, life-changing products to market faster.