Stop Managing Your CMO Relationships in Email

One Compliant Portal

FOR EVERY CMO REQUEST, FORM & APPROVAL

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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:

  • No Structured audit trail for regulatory inspection

  • No version control on forms, specifications, or documents

  • No visibility into due date compliance across outstanding requests

  • No escalation path when CMO responses are overdue

  • No 21 CFR Part 11-compliant record of the exchange

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

  • Create and route structured requests or forms to the CMO manually or trigger them automatically via API from internal systems (ERP, QMS, LIMS)

  • Configure workflows with or without approval steps depending on request type

  • Monitor due date compliance in real time across all open requests

  • Run compliance reports by CMO, request type, and time period

  • Receive CMO responses posted back to internal systems via API − no manual re-entry

  • Maintain version-controlled records of every form, document, and revision

  • Full audit trail for regulatory inspection − Part 11 compliant

CMO / CONTRACT MANUFACTURER SIDE

  • Review requests through a dedicated secure portal − no software to install

  • Respond upload documents, requests clarifications, or flag issues directly in the platform

  • Automatic reminders keep responses on schedule without manual follow-up

  • Full history of all exchanges available within the portal at any time

  • Status updates visible to the pharma team in real tine − no status emails needed

  • From Request to Resolution − Without Leaving the Platform

Submit
Route
Respond
Track
Report

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.

Status Tracking & Communication

Status Tracking & Communication

Both requesters and service agents see real-time updates, version control, status changes, timelines, and communications—all centrally logged.

SLA Management & Escalation Rules

SLA Management & Escalation Rules

Platform lets you configure service level targets and escalate items based on thresholds or overdue stages.

Reporting & Analytics

Reporting & Analytics

Dashboard reveals request volume trends, response times, backlog bottlenecks, and team workloads—enabling data-driven decisions.

Audits & Compliance

Audits & Compliance

Complete logs of request histories and processing steps help with tracking and regulatory compliance requirements.

Request Intake & Capture

Request Intake & Capture

Submissions come through various channels—web portals, email, word docs, excel, chat tools, or embedded forms. The platform captures and creates structured tickets out of incoming requests.

Secure & Compliant

GxP & 21 CFR Part 11

TRIEVR is FDA GxP and 21 CFR compliant. We go to extreme measures to monitor and prevent unintended access to the system, and to secure all data entrusted to us.  We treat your data as it should be — critical, private, and secure.

Categorization & Prioritization

Categorization & Prioritization

Each request is automatically tagged, prioritized by urgency or SLA rules,and routed to the appropriate team or individual.

Automated Workflows

Automated Workflows

Configurable built-in business rules guide the process through a structured flow.

Status Tracking & Communication

Status Tracking & Communication

Both requesters and service agents see real-time updates, version control, status changes, timelines, and communications—all centrally logged.

SLA Management & Escalation Rules

SLA Management & Escalation Rules

Platform lets you configure service level targets and escalate items based on thresholds or overdue stages.

Reporting & Analytics

Reporting & Analytics

Dashboard reveals request volume trends, response times, backlog bottlenecks, and team workloads—enabling data-driven decisions.

Audits & Compliance

Audits & Compliance

Complete logs of request histories and processing steps help with tracking and regulatory compliance requirements.

Dedicated-Request-Management-Platform-External-Manufacturers

External Manufacturing Management Benefits You Unlock

Benefits

Description

Efficiency Replace spreadsheets and email with tracked, standardized workflows.  Automate request routing, approvals, notifications, and escalation.
Visibility & Control See job‑work status, inventory at subcontractors, pending approvals.
Accountability & Compliance Audit trails, quality actions, approvals, and vendor SLAs captured centrally.
Scalability Flexible connections as your partners come and go.
Vendor Collaboration EM/CMOs update status directly; no tracking via email or phone.

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.

TRIEVR is very simple to implement.

  • Independent of all closed systems
  • No integration required
  • No IT required
  • Up and running in 30 min

Adopt TRIEVR and start saving time and aggravation.

Cancel anytime.