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A Pharmaceutical Quality Management System (QMS) ensures the consistent delivery of safe and effective products by integrating compliance, risk management, and continuous improvement practices.
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A Quality Management System in Pharmaceutical Industry 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 pharmaceutical QMS software can help businesses quickly and easily become compliant by providing complete end-to-end quality visibility right from design to delivery.
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 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.
Implementing the best QMS for pharmaceutical industry is crucial. The best QMS software for the pharmaceutical industry includes a set of processes, policies, and procedures to ensure that products meet the required quality standards and regulatory compliance. Here are some key reasons why implementing the top QMS Software for pharmaceutical industry is important:
Customer Success
CQ’s Pharmaceutical QMS solution is an integrated and harmonized regulatory compliance management system for the pharmaceutical industry that enables organizations to manage quality processes, risk management, and regulatory compliance. This system serves as a centralized hub for continuous improvement throughout the business. The solution can scale, build, and optimize quality and other systems, including ERP, CRM, and 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 regulatory compliance management system for pharmaceutical industry is automated with workflows for managing documents and processes, supporting audit trails, electronic reporting, compliant eSignatures, and dashboards. Available both on-premise and as a cloud-based QMS solution, it ensures seamless integration across platforms.
In an industry where lives depend on product quality, CQ Quality Intelligence helps meet public health, regulatory compliance, and operational excellence. It enhances transparency and data accuracy through electronic batch records and digital signatures, aligning with 21 CFR Part 11.
Access a comprehensive quality management database, customize reports, and harness data analysis tools for enhanced insights while reducing the risk of costly fines and product recalls. Generate standard reports in various formats, including PDF, Excel, and ASCII, and leverage dashboards included in every CQ solution.
CQ’s pharma quality management 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.
We have implemented CQ in a new medical device start up. The set up and implementation went very smooth and the support from the provider has been outstanding. The system fully supports compliance with ISO 13485. Some of the reasons why I would recommend the software are: – 100% cloud-based – Allow almost paperless Quality Management System – Excellent customer support – Simple set up and implementation – User friendly – Efficiency and security – Accessible cost for small companies.
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