SmartSolve® — The Most Complete QMS Software for Life Sciences
Gain better control and visibility of the important quality processes you manage every day with our electronic quality management system. Pilgrim Quality Solutions helps you manage product quality with confidence, enhance patient safety, and be more prepared for audits than ever before.
SmartSolve®, Pilgrim’s quality management software (QMS) provides you a complete suite of solutions specially engineered for the Life Sciences.
Based upon ISO 9001 quality management software standards, including GMP, GCP, and GLP, SmartSolve ISO quality management software facilitates compliance by providing:
- Support for electronic signature, audit trail, electronic reporting, and software validation requirements of regulatory bodies in Australia, Canada, Europe, Japan and the U.S.
- Closed-loop integration between processes that allows updates or issues from one workflow to initiate and populate complementary process workflows.
- A shared, common platform and central repository for simplified reporting, easier audit preparation, and increased visibility for better decision making.
- Unmatched support that helps you prepare for an audit and respond quickly to regulatory information requests.
Aligned with Industry and Regulatory Standards for Quality Management Systems
The ISO (International Organization for Standardization) standards for quality management systems serve as the basis for the Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) required by most government regulatory bodies. SmartSolve quality management software gives you the tools to automate those processes and makes it easier to deploy them across your value chain. Our QMS includes:
- Audit Management: Plan, manage, and conduct internal and external audits.
- CAPA Management: Implement processes to resolve corrective and preventive actions.
- Change Management: Ensure consistent and compliant change.
- Complaint Management: Capture customer complaints and adverse events.
- Document Management: Control and manage policies, standard operating procedures (SOPs), work instructions, and other important documents.
- Nonconformance Management: Capture, resolve, and track defects and deviations.
- Out Of Specification Management: Ensure consistent out-of-specification (OOS) lab result investigations.
- Supplier Quality Management: Ensure quality throughout your supply chain.
- Training Management: Demonstrate personnel competence and training.
- QMS Extensions: Automate business-specific quality processes, including calibration, recall management, or your preferred process.
Closed-loop Integration Initiates Actions
Industry standards and regulatory guidelines recommend quality management processes which are integrated across the entire value chain. Because the SmartSolve quality management software modules share a common platform, notifications, workflows, and data from separate processes are tightly linked. Activities and results in one module automatically inform and initiate actions in another, so you don’t have to. A few of SmartSolve’s integration points include:
- Changes to regulations, policies, SOPs, and work instructions trigger new employee training.
- Inspection issues can escalate to a nonconformance.
- An audit finding, nonconformance, or complaint may initiate a CAPA.
- A complaint can trigger output of the XML MedWatch Form 3500A for reportable adverse events.
Quality Metrics Tools Bring QMS 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 value-added intelligence tools. Our quality metrics options include:
- Reporting and Searches: Use built-in reports to calculate and report on quality data. .
- Business Intelligence: Extract actionable intelligence with prebuilt quality KPIs, metrics, and dashboards.
The SmartSolve Platform – Built for Quality and Compliance
Pilgrim delivers quality management software on a shared platform that has been built for Life Sciences compliance. The SmartSolve platform acts as a framework and offers a number of reusable functions. Platform benefits include:
- Electronic signatures, electronic records and reporting, and audit trails.
- Functional synergies between quality processes.
- Centralized repositories for true enterprise quality management.
- Application configuration tools to enable ongoing management.
- Drag-and-drop interface to spot trends and prepare reports.
- External integration through Web services.
- Extensible to automate business-specific quality management processes.