Ensure quality and compliance throughout the Pharmaceutical demand chain
Pharmaceutical quality professionals are facing more challenges, and have more opportunities to improve quality and compliance than ever before. Mergers and acquisitions, complex supply chains, data integrity issues, and tightening regulations are all forces that affect pharmaceutical quality strategies and processes on a day-to-day basis. Plus, the FDA and other regulatory bodies are increasingly focused not only on compliance, but on the importance of building a culture of quality.
An effective quality management system (QMS) will help you develop a culture of quality, support data integrity, keep suppliers under control, and maintain overall compliance. QMS data must also be structured to drive consistent metrics, risk calculations, and other trend analysis. It is also critical to have a QMS that can scale as new divisions, people, and processes are added to your organization.
Pilgrim Quality Solutions can help. Whether you need to develop a risk-based CAPA process, ensure that your team is adequately trained and following procedures, keep suppliers under control, investigate out-of-specification lab results, or structure your quality system data to support quality metrics and reporting, SmartSolve® gives you integrated quality management capabilities to achieve your goals.
SmartSolve Pharmaceutical QMS Solutions
Plan, manage, and conduct internal, supplier, and regulatory audits.
Implement a risk-based corrective and preventive action process for regulatory compliance.
Ensure consistent and compliant change throughout the organization.
Streamline complaint handling and regulatory reporting.
Capture, resolve, and track both supplier and internal deviations.
Build a foundation for quality and compliance.
Ensure consistent out-of-specification lab result investigations
Evaluate and manage product recalls and corrections.
Identify and focus on the suppliers that matter most.
Ensure a competent, compliant workforce.
Quality Intelligence Brings Actionable Insight
SmartSolve lets you gain insight over your quality management operations with built-in tools for monitoring key processes. You can keep tabs on trends, share reports throughout your organization, or get more hands-on with data analysis with our quality intelligence tools.
Tools to Tailor, Extend, and Integrate Quality Processes
Pilgrim’s Pharmaceutical QMS solutions are developed on SmartSolve's Platform for Compliance. SmartSolve's Platform Services, Enterprise Integration, and Configuration Tools make it easy to extend workflows and forms, integrate processes, and tailor capabilities as the demands on your quality management system grow. Plus, Pilgrim's secure, cloud-based deployment options and automated validation tools help your team get up and running on new processes quickly.