The SmartSolve® quality management platform has been purpose-built for the Life Sciences industries. SmartSolve acts as a framework for your quality management application modules and offers a number of enterprise platform services.
Shared, Structured Data for Continuous Improvement
SmartSolve’s quality and compliance processes are built on a common set of master data that is set up once and used throughout the system. New processes automatically inherit these data sets to ensure that your organization continues to speak a “common language” as your quality system grows.
- Configure the SmartSolve’s Organization Hierarchy to mirror your corporate structure
- Roll up or drill down data at any level for unparalleled reporting
- Restrict record access and visibility based on location, site, or division within hierarchy
Quality Beyond Your Four Walls
A fully mature quality system extends beyond the four walls of your organization. Whether this means communicating with field personnel, suppliers, customers, or even regulatory agencies, the SmartSolve enterprise platform services has your entire ecosystem covered.
- SmartSolve Mobile
SmartSolve is certified for all major browsers, which provides support for most mobile devices. Specific apps have been developed for high-demand, on-the-go activities. For example, SmartSolve Mobile Audit enables auditors to capture audit data while on-the-go and later sync it back to the corporate quality system for follow up.
- SmartSolve Quality Portal
This portal allows field personnel and extended demand chain partners (including known healthcare professionals, clinical investigators, and customers) to quickly submit incident information in a consistent format. It is a secure way for authorized, whitelisted reporters to submit data without directly accessing your protected quality management system and data.
- Electronic Medical Device Reporting (eMDR)
SmartSolve provides a direct bi-directional integration between SmartSolve Complaint Management and the FDA’s Electronic Submission Gateway for automated submissions and acknowledgements of post-market eMDR submissions.
Reporting and Visibility that Improves Quality
SmartSolve supports the data structure needed to drive reporting at all levels of the organization. Learn more about SmartSolve’s Quality Intelligence and Reporting capabilities.
Many Life Sciences organizations need the ability for their quality systems to support multiple languages and locales across the globe. SmartSolve is designed from the ground up to support these international needs without changing the core software solution.
When using SmartSolve’s internationalization/ localization capabilities:
- User interface displays using the language and/or locale selected by the user at login time.
- Users can easily navigate to and work within forms in their own selected language.
- Transactional data (data entered by end users) will be stored in the language in which it was entered.
- Dates are stored in Coordinated Universal Time (UTC) and are converted to the user’s local time zone for display and edit.
As new security threats emerge, Pilgrim continues to evolve our products to minimize the likelihood of unauthorized access, data manipulation, or deletion of sensitive data. SmartSolve security includes:
- Strict authentication and authorization rules for granting system access.
- Integration with Identity Access Management systems, such as Microsoft’s Active Directory.
- Federated Single Sign-On support with any SAML 2.0 or WS-Federation compliant Identity Provider.
- Security that can be set at the organization unit level.
- Validated and encoded data to provide protection against top security threats.
- Data that is encrypted both when in motion and when at rest.
Pilgrim continuously monitors the need to release software patches with security fixes as new vulnerabilities are identified.
SmartSolve optimizes quality system efficiencies with automated communications and processing.
- Automatic email notifications and dashboard alerts work alongside your quality processes and reduce the risk of a missed task or approval
- Heavy transactions are processed in the background so users can move on to other tasks
- Framework for plug-ins with third-party systems so non-SmartSolve users receive updates from other enterprise systems
Every SmartSolve solution shares a core set of capabilities that help you comply with regulatory requirements such as FDA 21 CFR Part 11 and EU Annex 11. Pilgrim continually monitors FDA and other regulatory requirements and incorporates updates to ensure continued compliance.
21 CFR Part 11 compliance capabilities include:
- Two-part electronic signatures at key process checkpoints including all tasks, approvals, and certification signoffs.
- Audit trails to keep detailed records of each change in the system, including all user interactions across every quality process.
- Flexible computer system validation (CSV) options including automated validation script execution.
- Electronic Medical Device Reporting (eMDR) capabilities.
SmartSolve’s performance-driven design improves productivity with rapid access to quality records and data.
- “Smart-loading” of forms minimizes loading time
- Commonly used data is cached to improve network bandwidth usage
- Data stored in a manner that makes extraction efficient
- Distributed architecture optimized for scaling up and scaling out