Pharmaceutical Quality Management System (Pharma QMS)
A quality management system helps pharmaceutical organizations ensure the quality of products and process improvements. It enforces compliance with US FDA, current Good Manufacturing Practice (cGMP), ISO 9001:2015, and other regulatory requirements and standards concerned. The manufacturing of products must be maintained at high standards to ensure the strength of the active components, quality, and purity of the products. It facilitates compliance with ICH Q10 and ISO guidance for common quality principles such as total employee involvement, customer focus, and a process-oriented approach. By achieving excellence in these core quality principles, pharma companies can maintain quality control and embark on a journey of continuous improvement
An effective pharmaceutical QMS will help to develop a culture of quality, support data integrity, reduce the time and cost to manage documents, identify and resolve problems in product development and introduction, manage supplier quality, and ensure a trained workforce. ComplianceQuest’s QMS software can help pharmaceutical businesses quickly and easily become compliant by providing complete end-to-end quality visibility right from design to delivery.
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.
The Benefits of Pharma QMS
Both the pharmaceutical industry and regulatory authorities give importance to manufacturing pharmaceutical products using processes and practices ensuring high levels of quality and safety.
Pharmaceutical regulation, the combination of administrative, legal, and technical measures, is aimed at the safety, potency, and quality of the drugs available to customers. This is done through a set of regulatory activities over the course of a drug’s life cycle including pre-market screening and assessment of new pharmaceuticals, review of manufacturing facilities, regulation of drug labeling and promotional activities, and post-marketing surveillance of drugs following approval.
ComplianceQuest’s quality and compliance software is an end-to-end solution facilitating enterprise-wide transparency and collaboration in managing quality initiatives and compliance processes for the pharma industry. It improves information management and provides unprecedented data visibility into every aspect of compliance through your product value chain. An intuitive pharmaceutical QMS can drive many organizational benefits, including:
- Cost-effective implementation, upgrades, and scaling
- Simpler software administration and better user adoption
- Lower ongoing training costs and monthly subscription or licensing fees
- Reasonable implementation and consulting costs
- Ability to adopt functionality
- More flexible vendor policies and more personalized vendor relationships
CQ Pharmaceutical QMS Solutions
CQ’s pharma solution is an integrated and harmonized quality management software solution that enables organizations to manage quality processes, risk management, and regulatory compliance to become a centralized hub for continuous improvement throughout the business. The solution can scale, build, optimize the quality and other systems including ERP, CRM, PLM systems to control all business processes.
This comprehensive solution, built under the ISO 9001 standard, is designed for managing compliance, quality, risk, and the supplier chain in the pharmaceutical vertical. The CQ solution is automated with workflows for managing documents and processes and support for audit trails, electronic reporting, compliant eSignatures, and dashboards. The CQ quality management software (QMS) solution is available on-premise or as a cloud QMS solution.
Quality Intelligence Brings Actionable Insight
CQ Quality Intelligence helps you proactively manage quality, comply with regulations, and mitigate risk easily with built-in QMS tools in pharma to gain strategic insight. You can access a fully-integrated quality management database across your value chain, control the format, appearance, and context of all your quality reports, or get more experienced with data analysis with our quality intelligence tools. Multiple standard reports can be produced in multiple formats, including PDF, Microsoft Excel, and ASCII, and dashboards are included with each CQ solution. You can get immediate access to accurate reporting and analytics for the identification of trends and patterns from all levels of the organization enabling faster and more predictable results. This is a strategic enterprise advantage insight that affords a proactive approach to counter any quality or compliance risk.
Tools to Tailor, Extend, and Integrate Quality Processes
CQ’s pharmaceutical quality management system software is developed on Salesforce.com platform and simplifies the integration process, minimizes cyber threats and unauthorized data access, extends modified workflows and forms, and improves productivity to meet your organization’s needs according to the demands on your pharmaceutical quality management system. Similarly, our deployment options and validation tools deliver incremental value and increase operational excellence while driving continuous improvement and growth.
Frequently Asked Questions
What is ICH Q10?
Difference between quality management and quality assurance
The focus of quality management is on fulfilling quality requirements by setting standards that define quality metrics and benchmarks whereas quality assurance identifies defects in products and issues with product development processes.
How to achieve pharmaceutical QMS objectives?
- a comprehensively designed and correctly implemented pharmaceutical quality management software incorporating GMP (good manufacturing practice) and QRM (quality risk management).
- Comprehensive documentation
- Adequately resourcing with competent personnel
- Providing suitable and sufficient equipment, facilities, and premises.