Stop Managing Your CMO Relationships in Email
TRIEVR gives pharma quality and operations teams a 21 CFR Part 11-compliant portal to route requests, forms, and approvals to contract manufacturers — with structured workflows, automatic reminders, and real-time due date compliance tracking.
The Way Pharma Teams Manage CMOs Creates Compliance Risk
Pharmaceutical companies managing contract manufacturers typically rely on email threads, Word documents, and spreadsheets to route change requests, specification updates, QA queries, and document approvals.
This creates:
When FDA reviews your CMO oversight program, email threads are not a sufficient audit trail. TRIEVR IS.
ONE PLATFORM. TWO SIDES. FULL ACCOUNTABILITY.
PHARMA / SPONSOR SIDE
CMO / CONTRACT MANUFACTURER SIDE
- 1Submit − Pharma team creates a structured request or populates a form within TRIEVR, or requests are generated automatically via API from internal systems such as ERP, QMS, or LIMS. Due date is set; workflow is configured (without or without approval routing).
- 2Route − The request is automatically delivered to the CMO’s portal. Confirmation of receipt is logged with timestamp.
- 3Respond − The CMO responds, uploads documents, or requests clarification directly in the portal. All exchanges are version-controlled and timestampede.
- 4Track −Both parties see real-time status. Automatic reminders fire before due dates. Escalation rules trigger on overdue items.
- 5Report − Due date compliance dashboards and audit-ready export available at any time. Every action logged for regulatory review.
Built for Pharma Quality Teams. Designed for CMO Accountability.
Due Date Compliance Monitoring
Track response compliance across all open requests in real time. Dashboard shows on-time rates by CMO, request type, and date range. Export audit-ready compliance reports for management and regulatory review.Due Date Compliance Monitoring
Track response compliance across all open requests in real time. Dashboard shows on-time rates by CMO, request type, and date range. Export audit-ready compliance reports for management and regulatory review.
Version Control
Every form, document, and request revision is tracked, timestamped, and retrievable. Meets 21 CFR Part 11 data integrity requirements. No overwriting − every version is preserved with full chain of custody.Version Control
Every form, document, and request revision is tracked, timestamped, and retrievable. Meets 21 CFR Part 11 data integrity requirements. No overwriting − every version is preserved with full chain of custody.
API Integration - Inbound & Outbound
Internal systems (ERP, QMS, LIMS) can post requests directly into TRIEVR via API − no manual entry. When the CMO responds, TRIEVR posts the response back to your internal systems automatically. TRIEVR works standalone or fully integrated − your choice, no IT project required to get started.API Integration - Inbound & Outbound
Internal systems (ERP, QMS, LIMS) can post requests directly into TRIEVR via API − no manual entry. When the CMO responds, TRIEVR posts the response back to your internal systems automatically. TRIEVR works standalone or fully integrated − your choice, no IT project required to get started.
Configurable Workflows
Route requests with or without approval steps. Simple requests types go direct; complex change requests route through multi-step approval chains. Configurable per request category − no IT required to set up.Configurable Workflows
Route requests with or without approval steps. Simple requests types go direct; complex change requests route through multi-step approval chains. Configurable per request category − no IT required to set up.
Structured Request Intake
Replace email and Word docs with structured forms. Submissions are automatically organized, categorized, and routed − no manual sorting. Custom form templates per request type.Structured Request Intake
Replace email and Word docs with structured forms. Submissions are automatically organized, categorized, and routed − no manual sorting. Custom form templates per request type.
Reporting Audit Trail
Complete, exportable audit trail of every request, response, approval, and escalation. Audit-ready at any moment. Available to inspectors without manual reconstruction from email archives.Reporting Audit Trail
Complete, exportable audit trail of every request, response, approval, and escalation. Audit-ready at any moment. Available to inspectors without manual reconstruction from email archives.
21 CFR 11 / GxP Compliance
Compliance-Grade Infrastructure. Electronic records, audit trails, access controls, and data integrety built in from the group up. TRIEVR treats your data as regulated data − because it is.21 CFR 11 / GxP Compliance
Compliance-Grade Infrastructure. Electronic records, audit trails, access controls, and data integrety built in from the group up. TRIEVR treats your data as regulated data − because it is.
Automatic Reminders & Escalation
Set due dates and configure reminder schedules. Automatic escalation when responses are overdue − to the CMO, and internally. Remove manual follow-up from your team's workload entirely.Automatic Reminders & Escalation
Set due dates and configure reminder schedules. Automatic escalation when responses are overdue − to the CMO, and internally. Remove manual follow-up from your team’s workload entirely.
Real-Time Status & Communication
Both pharma and CMO see live request status, version history, and all communications − centrally logged. No status meetings. No...can you check on that...email.Real-Time Status & Communication
Both pharma and CMO see live request status, version history, and all communications − centrally logged. No status meetings. No “can you check on that?” email.
Due Date Compliance Monitoring
Track response compliance across all open requests in real time. Dashboard shows on-time rates by CMO, request type, and date range. Export audit-ready compliance reports for management and regulatory review.Due Date Compliance Monitoring
Track response compliance across all open requests in real time. Dashboard shows on-time rates by CMO, request type, and date range. Export audit-ready compliance reports for management and regulatory review.
Version Control
Every form, document, and request revision is tracked, timestamped, and retrievable. Meets 21 CFR Part 11 data integrity requirements. No overwriting − every version is preserved with full chain of custody.Version Control
Every form, document, and request revision is tracked, timestamped, and retrievable. Meets 21 CFR Part 11 data integrity requirements. No overwriting − every version is preserved with full chain of custody.
API Integration - Inbound & Outbound
Internal systems (ERP, QMS, LIMS) can post requests directly into TRIEVR via API − no manual entry. When the CMO responds, TRIEVR posts the response back to your internal systems automatically. TRIEVR works standalone or fully integrated − your choice, no IT project required to get started.API Integration - Inbound & Outbound
Internal systems (ERP, QMS, LIMS) can post requests directly into TRIEVR via API − no manual entry. When the CMO responds, TRIEVR posts the response back to your internal systems automatically. TRIEVR works standalone or fully integrated − your choice, no IT project required to get started.
Configurable Workflows
Route requests with or without approval steps. Simple requests types go direct; complex change requests route through multi-step approval chains. Configurable per request category − no IT required to set up.Configurable Workflows
Route requests with or without approval steps. Simple requests types go direct; complex change requests route through multi-step approval chains. Configurable per request category − no IT required to set up.
Structured Request Intake
Replace email and Word docs with structured forms. Submissions are automatically organized, categorized, and routed − no manual sorting. Custom form templates per request type.Structured Request Intake
Replace email and Word docs with structured forms. Submissions are automatically organized, categorized, and routed − no manual sorting. Custom form templates per request type.
Reporting Audit Trail
Complete, exportable audit trail of every request, response, approval, and escalation. Audit-ready at any moment. Available to inspectors without manual reconstruction from email archives.Reporting Audit Trail
Complete, exportable audit trail of every request, response, approval, and escalation. Audit-ready at any moment. Available to inspectors without manual reconstruction from email archives.
21 CFR 11 / GxP Compliance
Compliance-Grade Infrastructure. Electronic records, audit trails, access controls, and data integrety built in from the group up. TRIEVR treats your data as regulated data − because it is.21 CFR 11 / GxP Compliance
Compliance-Grade Infrastructure. Electronic records, audit trails, access controls, and data integrety built in from the group up. TRIEVR treats your data as regulated data − because it is.
Automatic Reminders & Escalation
Set due dates and configure reminder schedules. Automatic escalation when responses are overdue − to the CMO, and internally. Remove manual follow-up from your team's workload entirely.Automatic Reminders & Escalation
Set due dates and configure reminder schedules. Automatic escalation when responses are overdue − to the CMO, and internally. Remove manual follow-up from your team’s workload entirely.
Real-Time Status & Communication
Both pharma and CMO see live request status, version history, and all communications − centrally logged. No status meetings. No...can you check on that...email.Real-Time Status & Communication
Both pharma and CMO see live request status, version history, and all communications − centrally logged. No status meetings. No “can you check on that?” email.
External Manufacturing Management Benefits You Unlock
Benefits |
Description |
|---|---|
| Efficiency | Eliminate manual request routing, email follow-up-, and spreadsheet tracking. Structured workflows replace ad hoc coordination with repeatable, auditable processes. |
| Visibility & Control | Real-time dashboard shows every open request, current status, due date, and responsible party − across all CMOs at once. No digging through inboxes. |
| Accountability & Compliance | Complete audit trail, version-controlled documents, electronic records, and due date compliance reporting − designed for FDA inspection readiness. |
| Scalability | Add CMOs, request types, and form templates as your external manufacturing network grows. No IT involvement, no system reconfiguration. |
| CMO Collaboration | CMOs respond through a dedicated secure portal. No software installation on their end. No training overhead. Adoption is immediate. |
| System Integration | TRIEVR fits into your existing technology stack via API. Internal systems trigger requests automatically; CMO responses post back without manual re-entry. No data lives in two places, and no reconciliation is needed between TRIEVR and your QMS or ERP. |
Simple to Implement
External manufacturing management requires structured coordination with vendors, material flows, and quality control. When paired with TRIEVR’s request management platform, you gain a scalable, auditable, and efficient way to manage EM/CMO processes—from job-work requests to delivery tracking and issue handling—all centralized in one system.