Atlas Systems Named a Representative Vendor in 2025 Gartner® Market Guide for TPRM Technology Solutions → Read More
.png?width=869&height=597&name=image%20(5).png)
.png?width=300&height=175&name=Rectangle%2034624433%20(2).png)
Third-Party Risk Management Built for Life Sciences Industry
GxP vendor qualification, clinical trial partner oversight, and FDA-compliant documentation across CROs, CMOs, and supply chain partners.
.png?width=600&height=63&name=download%20(1).png)
TPRM Challenges Facing Life Sciences Organizations
GxP vendor qualification and ongoing oversight
FDA expects documented vendor qualification, periodic re-qualification, and change control management for vendors supporting GMP manufacturing, GLP studies, and GCP clinical trials.
Clinical trial vendor complexity
Multi-site global trials involve dozens of CROs, central labs, imaging centers, and investigator sites requiring coordinated qualification and monitoring across geographies.
Data integrity and system validation
Vendors providing electronic systems for clinical data management, laboratory information management, or manufacturing execution require computer system validation and data integrity assessments.
Supply chain quality and continuity
API suppliers, excipient manufacturers, and packaging vendors require supplier quality agreements, audit programs, and business continuity assessments preventing drug shortages.
FDA inspection readiness
Regulatory inspections expect complete vendor qualification files, ongoing monitoring records, and evidence of corrective action follow-up when vendor issues arise.
How ComplyScore® Addresses Third-Party Risks in Life Sciences and Pharma Industries
GxP Vendor Qualification and Management
ComplyScore® maintains GxP-compliant vendor qualification workflows including initial assessments, risk-based categorization, approval processes, and periodic re-qualification scheduling. Assessment templates validate vendor quality management systems, personnel qualifications, facility conditions, data integrity controls, and regulatory compliance history. The platform tracks vendor qualification status, certificate expiration dates, and re-qualification due dates with automated alerts ensuring continuous GxP compliance. All qualification activities maintain 21 CFR Part 11 compliant audit trails.
Clinical Trial Partner Oversight
Specialized questionnaires assess CRO capabilities including protocol adherence, adverse event reporting, source document verification, investigator training, and regulatory submission experience. The platform tracks clinical trial vendor performance metrics including enrollment rates, protocol deviations, data query resolution times, and inspection findings. When CROs engage sub-contracted services, ComplyScore® triggers assessments evaluating whether quality agreements and equivalent oversight apply throughout the clinical trial supply chain.
Data Integrity and CSV Documentation
Automated assessments evaluate vendor electronic systems against FDA data integrity guidance and GAMP5 requirements. The platform collects computer system validation documentation including validation plans, test scripts, validation reports, and periodic review records. Evidence repository centralizes vendor system validation files supporting FDA inspection responses and demonstrating appropriate oversight of systems generating GxP-regulated data.
Supplier Quality and Business Continuity
ComplyScore® tracks supplier quality agreements, audit schedules, and corrective action follow-up for API manufacturers, excipient suppliers, and packaging vendors. Continuous monitoring alerts you when suppliers experience FDA warning letters, quality issues, or manufacturing disruptions. Business continuity assessments evaluate supplier redundancy, inventory levels, and alternative source availability. This visibility prevents supply chain disruptions affecting clinical trial timelines and commercial drug availability.