Pharmaceutical Quality Management System | Biotech
A PHARMACEUTICAL QMS system designed to address the complex
requirements of regulations and standards
Pharmaceutical Quality Management System Accelerates Time to Market
Life expectancy and quality of life throughout the world is increasing, thanks in large part to innovative drugs. Companies in the pharmaceutical and biotechnology industries must develop new medicines quickly to continue their life-enhancing missions. The stopwatch is ticking every day your product isn’t on the market.
In addition, compliance with current good manufacturing practice (cGMP) regulations is a part of standard pharmaceutical quality operations. However, the use of legacy systems and paper-based processes make it difficult to control processes and systematic oversight.
AssurX’s pharmaceutical quality management system automates all processes required to ensure final products are manufactured according to customer and regulatory requirements. Moreover, our QMS system for pharma and biotech is a unified platform of interconnected workflows, which resolves and prevents quality deviations.
Over the course of a year, EyePoint Pharmaceuticals went from having separate solutions for document management and training to a fully integrated quality management system. Solutions deployed in AssurX include document management, training management, supplier quality, CAPA, internal and external audits.
AssurX Pharmaceutical Quality Management System Facilitates Compliance
The pharmaceutical and biotechnology industry face some of the strictest regulations today. Although the requirements vary, all encourage the use of automated, risk-based quality management techniques in all aspects of production and quality assurance.
AssurX is designed to address the complex requirements of regulations and standards, including:
AssurX Pharmaceutical EQMS: Features and Benefits
Managing the drug development is a lengthy, costly, and complex process. Using the right pharmaceutical EQMS gives your organization the tools needed to: manage all deviations. It can also help you to measure customer satisfaction, create standardized documents. Our QMS in pharma can also facilitate training, assure consistency between QMS requirements and guidelines, and incorporate additional quality management processes into your system.
AssurX features and benefits for drug manufacturers using our pharmaceutical compliance management software include:
A fully automated platform increases in efficiency.
In the race to be the best in the market, a labor-intensive manual system only creates delays. Moreover, outdated manual processes create a reactive stance for managing quality issues. Therefore, companies require a configurable and flexible system for quality management in life sciences.
By fully automating your pharmaceutical quality management system, errors are removed and tasks move along a predictable path. Additionally, it provides proactive insights and increases efficiency and productivity. Consequently, a fully automated QMS in the pharmaceutical industry speeds up turnaround time and reduces errors stemming from manual input.
A closed-loop, centralized platform provides a single source of truth.
AssurX seamlessly connects document control, training management, deviations and CAPA, audit, and other quality processes in an integrated platform. Users and stakeholders have one system for all quality documents and task management. Likewise, auditors and regulators will be able to view all quality information in one place.
Complete transparency increases accountability.
Automated rules create transparency across the quality management system. It gives insight into all tasks and the person(s) assigned to each task. Dashboards and analytics make it easier to pinpoint bottlenecks and gaps in your processes. Such transparency increases accountability to help improve performance.
Robust analytics help mitigate quality issues.
Analytics and reporting tools in our pharma compliance software facilitate monitoring of quality issues. These tools give you a 360 picture of your current state of compliance. Pharmaceutical compliance software generates timely reports and metrics. This helps enables users to drill-down into trends to analyze issues and prioritize mitigation and preventive strategies.
FDA 21 CFR Part 11 compliant audit trail and e-signatures ensure data integrity.
The FDA requires data integrity to ensure product quality and patient safety in the pharmaceutical and biotech industries. AssurX’s audit trail and electronic signature capabilities exceed the expectations of 21 CFR Part 11 requirements. The secure audit trail automatically captures any changes made to records, who made them, and when. The QMS system also controls user rights and access to reinforce security to maintain data integrity.
Quality Management System Validation Services
Computer system validation (CSV) traditionally meant validating all QMS software features and documenting all details. AssurX offers CSA validation services based on the FDA’s risk-based approach, dramatically reducing validation time and cost.
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AssurX: Quality & Compliance Systems for Every Enterprise
AssurX is designed for every type of enterprise with strict quality requirements, including companies in the pharmaceutical and biotechnology industry. AssurX specializes in quality management systems for the life sciences, with more than two decades of experience built into the AssurX QMS software solution. Companies throughout the world rely on our solutions and services to manage and improve drug and combination product manufacturing quality.
One Platform. Every Solution.
Easily integrate all your quality management and regulatory compliance processes into a single quality software system with AssurX. AssurX provides all core quality and compliance processes within the software system. This removes the need to budget for and install individual quality “modules.” Pre-configured workflows are available to you from day one with our quality management software.
Benefit from pre-configured workflows right from the start, ensuring a smooth transition to digital quality management. AssurX is an exceptional platform that facilitates transitioning from a labor-intensive, paper-based process to a streamlined electronic system. By adopting AssurX, you can embrace the enhanced organization that comes with digitizing documents and files.
With AssurX, enjoy the convenience of easily searchable data, allowing for quick retrieval and efficient information management, and saving valuable time. AssurX stands out as a user-friendly platform that allows for easy deployment, configuration, and integration with other software solutions.
First, implement the solutions you need now, then seamlessly connect more as you are ready. No other quality management system is easier to deploy, configure, and modify. Integrations with other software solutions make AssurX invaluable. Bid farewell to data silos and welcome a unified system for maximum efficiency.
