← All workflows

Quality Agreement

Draft Pharma Quality Agreements in Minutes, Not Hours

14 minutes with CaseMark

Fast lane

We have it from here.

Choose the fast one-off run here, or jump into the workspace when you want saved history, revisions, and a fuller matter workflow.

Run this once here

Best for a quick one-off job. Add your email, upload the files, and we'll run the workflow and send the result to your inbox.

1. Add your email so we know where to send the result.

2. Upload the files you want analyzed.

3. Run the workflow and we'll take it from there.

Use in Workspace

Best for ongoing matters

Save and reopen matters, keep documents together, refine the output, rerun with changes, and export or share polished work product when you're done.

Open in Workspace

Need more context?

Scroll for the workflow details below if you want to review what this run handles, what documents help, and what the output looks like.

If this is part of a live matter, the workspace is the better fit: you can keep your documents together, revisit the result, and keep working without starting from scratch.

Jump to detailsOpen in Workspace

Start here

Run this workflow now

Best for a fast one-off run. Add your email, upload the files, and we'll deliver the result without sending you into the full app.

Workflow

Quality Agreement

Step 1 · Deliver to

Step 3 · Run this workflow

Workflow

Quality Agreement

Overview

CaseMark's Quality Agreement skill uses AI to draft comprehensive, FDA-compliant Quality Agreements for pharmaceutical contract manufacturing relationships. It assigns quality roles and responsibilities between product owners and contract manufacturing organizations (CMOs) under 21 CFR 210/211, ICH Q7, and related regulatory guidance. The result is a detailed, execution-ready agreement covering everything from batch record management to CAPA protocols.

Drafting Quality Agreements for contract pharmaceutical manufacturing is a painstaking process that typically involves weeks of back-and-forth between quality, regulatory, and legal teams. Each agreement must precisely assign dozens of quality functions under complex FDA and ICH frameworks, and any ambiguity can lead to compliance failures, warning letters, or product recalls. The manual process is error-prone, inconsistent across CMO relationships, and consumes significant resources from already stretched quality organizations.

CaseMark automates the drafting of Quality Agreements by analyzing your manufacturing agreements, product specifications, and existing quality documents to produce a comprehensive, regulation-aligned agreement in minutes. The AI generates detailed responsibility matrices, change control workflows, CAPA provisions, and audit rights clauses—all structured to meet FDA cGMP and ICH Q7 expectations—so your quality team can focus on review and negotiation rather than drafting from scratch.

How it works

  1. 1. Upload your manufacturing agreement, product specifications, and any existing quality documents

  2. 2. AI analyzes regulatory requirements and extracts key party details, product scope, and compliance obligations

  3. 3. Review the fully drafted Quality Agreement with responsibility matrices, change control workflows, and CAPA provisions

  4. 4. Export the finalized agreement in your preferred format (DOCX, PDF) for execution

What you get

  • Parties & Scope with Regulatory IDs

  • Definitions and Quality Unit Authority Matrix

  • Manufacturing, Documentation & Change Control Provisions

  • Audit, Inspection & Quality Events (CAPA) Sections

  • Specifications, Release & Personnel Requirements

  • Term, Termination & Appendices (Templates, Metrics, Contacts)

What it handles

  • Automated quality unit responsibility matrix assigning roles between product owner and CMO

  • Change control workflows with categorization and approval timelines

  • Audit and inspection rights clauses including 483 response coordination

  • Quality events, deviation reporting, and CAPA approval frameworks

  • FDA cGMP (21 CFR 210/211) and ICH Q7 regulatory alignment

  • Specifications, method validation, and stability program provisions

Required documents

  • Manufacturing or Supply Agreement

    The commercial manufacturing or supply agreement defining product scope, facility details, and contractual terms between the product owner and CMO

    .pdf, .docx

  • Product Specifications

    Approved product specifications including dosage form, API details, classification, analytical methods, and stability protocols

    .pdf, .docx, .xlsx

Supporting documents

  • Existing Quality Agreement

    Any prior or current quality agreement between the parties to inform updates and ensure continuity

    .pdf, .docx

  • Regulatory Correspondence

    FDA 483 observations, warning letters, establishment inspection reports, or other regulatory correspondence relevant to either party

    .pdf, .docx

  • Standard Operating Procedures

    Relevant SOPs for change control, deviation management, CAPA, or other quality system processes from either party

    .pdf, .docx

Why teams use it

Reduce drafting time from weeks to minutes with AI-generated quality agreements tailored to your specific manufacturing relationship

Ensure regulatory alignment with FDA cGMP requirements, ICH Q7, and current industry guidance built into every clause

Eliminate ambiguity in quality role assignments with an automatically generated responsibility matrix for product owners and CMOs

Maintain consistency across multiple CMO relationships with standardized yet customizable agreement structures

Questions

What regulatory frameworks does this Quality Agreement follow?

CaseMark drafts Quality Agreements aligned with FDA cGMP regulations (21 CFR Parts 210 and 211), ICH Q7 guidelines for active pharmaceutical ingredients, and related FDA guidance on quality agreements for contract manufacturing. The output reflects current regulatory expectations for quality role assignment.

Can I use this for both API and finished dosage form manufacturing?

Yes. CaseMark supports Quality Agreements for APIs, finished pharmaceutical products, biologics, and OTC products. Simply upload the relevant product specifications and the AI will tailor the agreement to the appropriate dosage form and regulatory classification.

Does the agreement include a responsibility matrix?

Absolutely. CaseMark automatically generates a detailed Quality Unit Responsibility Matrix that clearly assigns each quality function—batch release, deviation management, change control, audits, and more—to either the product owner or the CMO, with shared responsibilities clearly noted.

How does CaseMark handle change control and CAPA provisions?

CaseMark drafts comprehensive change control sections with categorization tiers, approval workflows, and defined review timelines. CAPA provisions include deviation reporting triggers, investigation responsibilities, corrective action approval authority, and recall coordination protocols.

Can I incorporate existing SOPs and prior quality agreements?

Yes. You can upload prior quality agreements, SOPs, inspection histories (including FDA 483s), and warning letter responses. CaseMark analyzes these documents to ensure the new agreement addresses known compliance gaps and aligns with your existing quality systems.

Is the output ready for execution or does it need legal review?

CaseMark produces a thorough, professionally structured draft that covers all major regulatory and operational requirements. We recommend a final review by your quality and legal teams to confirm company-specific terms, but the draft significantly reduces the time and effort needed to reach an executable agreement.

Related

Access and Indemnity Agreement (Due Diligence)

Draft Property Access Agreements in Minutes with AI

Access Indemnity Agreement

Draft Access & Indemnity Agreements in Minutes

Ad Fund Agreement

Draft Ad Fund Agreements in Minutes, Not Hours