SmartSolve® – Your Validation-Ready Solution for Quality Compliance Management
Regulations are global and complex, and so is your business. For more than 20 years, Life Sciences firms have partnered with Pilgrim Quality Solutions to achieve regulatory compliance. SmartSolve® is a complete suite designed to address all facets of your quality compliance management needs from pre-market to post-market operations including support for clinical trials, supplier management, manufacturing and distribution. Our solution supports your compliance efforts with:
- A complete suite of quality management applications to enable closed-loop integration as suggested by regulatory bodies.
- Electronic signatures and audit trails to support 21 CFR Part 11 compliance.
- Decision trees to help you determine when and where complaint and adverse event reports should be submitted.
- FDA and MedDRA dictionary integration to aid your team in standardized incident coding.
- Medical Device Reports (eMDRs) and Adverse Event Reports (AERs) that can be easily produced and submitted electronically.
- A validation-ready solution with validation packs included with your applications.
Helping You Achieve Compliance
We work closely with regulators around the world to stay abreast of compliance management requirements to keep you and our compliance management software on track for compliance.
- Close working relationships with Australia TGA, Health Canada, Europe EMA, Japan PMDA, and US FDA influence our product enhancement plans and priorities.
- Involvement in regulatory pilot programs give regulators real-world industry and technology perspectives on which to shape future regulations.
- Quarterly regulatory updates keep customers abreast of important changes impacting their compliance management.
Unmatched Audit Support - Ready When You Need It Most
As you prepare for an audit, let us help you. We have helped hundreds of medical device, pharmaceutical and biotech firms stock their prep-rooms with the critical information they need for an audit. Just call our support line, and your Pilgrim Technical Support team will direct you toward the SmartSolve information and reports you need to produce and review prior to your audit. Then, as your audit date approaches, the entire Pilgrim team is on alert and ready to back you up on a moment’s notice. Information requests from customers during active audits receive the highest priority and are given immediate attention.