Vendor oversight is a regulatory requirement that comes with some tough challenges.
Whether you’re managing CROs, CMOs, or suppliers of GMP-critical components, your vendor management audit program needs to do more than check a box. It needs to hold up to FDA inspections, ISO audits, and internal reviews without adding unnecessary complexity to your team’s day-to-day operations.
In this guide, we’ll walk through how to build (or upgrade) a vendor management audit program that meets regulatory expectations while aligning with how your team actually operates.
What Is a Vendor Management Audit Program?
A vendor management audit program is a structured process for evaluating, qualifying, and monitoring external partners to ensure compliance with applicable quality and regulatory requirements.
Or in other words, it's an organized way to check that the companies you work with are doing things the right way and following the important rules, so that your team stays compliant.
In life sciences, this typically applies to third parties that impact:
- Product quality (e.g. raw materials, manufacturing services)
- Clinical data integrity (e.g. CROs or EDC vendors)
- Regulatory compliance (e.g. labs, software providers, packaging)
- GxP activities (e.g. storage, distribution, validation)
Regulators expect a clear, documented process for selecting vendors, defining responsibilities, performing risk assessments, and conducting audits, especially for vendors performing critical tasks under 21 CFR Part 11, Part 820, or EU Annex 11.
Why It Matters: Audit Risk and Regulatory Pressure
Vendor issues remain a top contributor to 483 observations and ISO audit findings. In fact, FDA warning letters increasingly cite lack of supplier oversight, especially in combination product manufacturing and outsourced quality functions.
Even if your internal quality systems are airtight, an overlooked vendor can become a liability. That’s why vendor qualification and auditing should be treated as part of your broader quality management approach rather than a standalone spreadsheet that can get lost in the shuffle.
What Should Be Included in a Vendor Management Audit Program?
A robust program usually includes:
1. Vendor Classification & Risk Assessment
Before you can manage vendors effectively, you need to understand which ones pose the highest risk to product quality or regulatory compliance.
Not every vendor requires the same level of oversight. A supplier of your core API, for example, carries far more regulatory weight than the vendor who prints marketing brochures. That’s why a risk-based classification system is essential.
By assigning risk levels based on factors like product impact, regulatory exposure, and historical performance, you create a scalable system for audit planning and monitoring.
It also helps you justify your approach during inspections. Regulators want to see that you’re focusing efforts where they matter most and that your decisions are backed by a consistent rationale.
Your vendor audit management program should:
- Categorize vendors based on the criticality of their services or product
- Assign risk levels (high/medium/low) to determine audit frequency and depth
- Document your rationale: inspectors want to see a consistent, risk-based approach
Once you’ve assigned risk levels, build a risk register or matrix that’s easy to update over time. Vendor risk can evolve, especially after mergers, facility changes, or nonconformances, so treat this as a living part of your quality system.
Ideally, you'll want to integrate this into your quality management system (QMS), allowing for automatic reminders, linked CAPAs, and version-controlled records, which are critical when facing an inspection or audit.
2. Vendor Qualification Criteria
After classifying vendors by risk, the next step is making sure each one meets your standards before they start providing services.
This is your qualification phase, where you confirm that the vendor has the right controls, certifications, and procedures in place to support your quality and regulatory commitments. It’s especially important for vendors handling GMP-related tasks or contributing to GxP data.
Qualification isn’t just about checking boxes . It’s about ensuring alignment. You want to work with vendors who understand your quality expectations and are willing to meet them. That may involve requesting ISO certificates, reviewing validation documentation, or executing a formal quality agreement that spells out responsibilities on both sides.
Your vendor audit management program should:
- Define what documentation or certifications are required (ISO 13485, Part 11, etc.)
- Collect and review SOPs, validation packages, and quality agreements
- Ensure vendors understand and agree to your compliance expectations
Make sure to document all of this clearly in your QMS, not only to support compliance, but also to provide your team with visibility into vendor status.
If you're using spreadsheets or shared drives, this step often becomes fragmented or out-of-date. A QMS built for pharma and life sciences will centralize vendor profiles, SOPs, qualification docs, and expiration reminders, making it easy to prepare for requalification or audits.
3. Audit Planning & Execution
Once vendors are qualified, regular audits are your main tool for ongoing oversight. Audits help you verify that vendors are following their stated procedures and maintaining the level of control required for your regulated environment. A risk-based audit schedule ensures that high-risk vendors are assessed more frequently, while still keeping oversight proportional and manageable.
Planning is key.
Audits should follow a consistent format, with pre-defined criteria based on the services the vendor provides. This allows you to assess everything from equipment maintenance and data integrity to training records and change control. It also makes it easier to compare audits across vendors and identify trends.
Your vendor audit management program should:
- Establish a vendor audit schedule based on risk level and past performance
- Use standardized audit templates to evaluate procedures, records, and training
- Capture findings in a consistent format, with CAPA follow-up where needed
After the audit, it’s crucial to follow up on findings. If issues are identified, corrective and preventive actions (CAPAs) should be opened, tracked, and resolved within defined timelines.
A good QMS links findings directly to CAPAs, so you can easily show regulators what was identified and how it was addressed. This is one of the areas where many companies fall short, not because they miss issues, but because they fail to close the loop.
4. Ongoing Monitoring
Auditing isn’t a one-and-done activity.
Ongoing vendor monitoring ensures you’re capturing performance signals between formal audits. Metrics like on-time delivery, product quality, and responsiveness to CAPAs can reveal which vendors are improving and which may need requalification or more frequent audits.
Effective monitoring also helps you detect risk before it becomes a problem.
If a vendor starts missing delivery windows or accumulating nonconformances, it may be time to reassess their risk level. That reassessment should be documented and, if needed, tied to a change in audit frequency or a revision to the quality agreement.
Your vendor audit management program should:
- Track vendor performance metrics (on-time delivery, nonconformances, audit findings)
- Reassess risk as conditions change (e.g., changes in ownership, facilities, or services)
- Include periodic requalification checkpoints
Many teams rely on spreadsheets or emails to monitor vendors, which makes trend analysis nearly impossible. By integrating performance tracking into your QMS or vendor management module, you can flag issues automatically and maintain a real-time view of vendor status.
This also helps you prepare for inspections, especially if an auditor asks how you’re keeping tabs on supplier reliability.
5. Documentation & Recordkeeping
Proper documentation is the backbone of any compliant vendor management program. From audit reports and CAPAs to quality agreements and requalification notes, your records must be clear, traceable, and inspection-ready at all times.
Regulators expect to see a full story, not just that you performed an audit, but what you found, how you responded, and how it ties into your broader QMS.
Beyond meeting regulatory expectations, organized documentation saves time and reduces audit panic. When vendor records are scattered across inboxes or local drives, it’s nearly impossible to pull them together quickly during an inspection.
This is why so many teams are shifting to validated systems with built-in document control. At minimum, your system should:
- Maintain signed quality agreements
- Archive audit reports, CAPAs, and correspondence
- Ensure all records are Part 11-compliant, traceable, and inspection-ready
Make sure all records are stored in a Part 11–compliant system, with metadata, audit trails, and digital signatures captured automatically. This makes it easy to prove who did what, when, and why, which is often the difference between a clean inspection and a major finding.
Systems like Kivo ensure your documents are automatically structured for compliance.
Common Pitfalls to Avoid
Even experienced teams run into trouble when vendor management is siloed or manual. Some common issues include:
- Storing audit records in generic file-sharing systems that lack Part 11 audit trails
- Using inconsistent audit templates that vary between auditors or regions
- Missing requalification triggers due to lack of automated reminders
- No link between CAPAs and vendor performance, making it hard to track systemic issues
The easiest fix to all of these pitfalls is to use a QMS that connects vendor records, audits, training, and CAPAs in one system of record, complete with version control, digital signatures, and configurable workflows to match your team’s approach.
Helpful Solutions For Vendor Management
Every step of your vendor management audit program needs to hold up under scrutiny, and that's very difficult to pull off via spreadsheets and email chains.
Below, we’ve outlined some of the most helpful solutions for building a vendor management audit program that’s both compliant for your organization and practical for your team.
1. QMS with Integrated Vendor Management
A purpose-built QMS platform like Kivo lets you manage vendor records, audits, CAPAs, and training in a centralized, validated environment. Unlike SharePoint folders and spreadsheets, Kivo:
- Enables audit trail–compliant recordkeeping (Part 11, ISO 13485)
- Ties audit findings directly to CAPAs
- Triggers automated requalification reminders
- Allows role-based access so only qualified auditors access vendor files
What makes Kivo especially practical for life sciences teams is that we use a single underlying DMS for QMS, RIM, and eTMF, so all your team's documents (including vendor audit documents) are assignable across every department, rather than living in silos and needing to be synced, duplicated, or updated multiple times.
2. Validated eSignature & Audit Trail Tools
Many teams still collect audit responses or vendor approvals via email or unsecured PDFs, which doesn’t fly with regulators.
Look for Part 11–compliant e-signature platforms that integrate with your document system. Good options include:
- Kivo’s built-in document and signature workflows
- DocuSign CFR Part 11 module (for teams already using DocuSign)
- MasterControl eSignature tools (for larger, enterprise deployments
For small-to-midsized life sciences teams, getting this feature directly through your QMS can result in substantial savings.
3. Vendor Audit Template & Checklist Libraries
Standardizing your audit process ensures consistency across geographies, products, and auditors. It also demonstrates to auditors that you have a structured approach.
Helpful tools and resources for this include:
- Kivo’s configurable audit workflows and templates
- FDA’s Quality System Inspection Technique (QSIT) for supplier audits
- Prebuilt checklists aligned to ISO 13485:2016 or 21 CFR Part 820
Using or developing these types of templates will give your team a repeatable, inspection-ready framework that helps avoid gaps and ensures every vendor audit is thorough and well-documented.
4. Supplier Portals or External Collaboration Workspaces
Collaborating with vendors on audit prep, document sharing, and CAPA responses is risky via email. A secure, access-controlled portal helps:
- Share templates or quality agreements with version control
- Track audit response timelines
- Collect and review vendor SOPs and certifications in one place
Kivo’s vendor portal tools are built for this exact purpose.
5. Performance Tracking Dashboards
Once the audits are done, how do you know which vendors are slipping? A vendor scorecard or dashboard helps track:
- On-time delivery
- Non-conformances
- Repeat audit findings
- Requalification status
Platforms like Kivo and MasterControl can auto-generate this based on linked audit, CAPA, and training data.
Build A System You’ll Actually Use
There are a lot of strong, compliant solutions for helping you run your vendor management audit program. The best system for your organization isn't the one with the most bells and whistles. It's the system your team will actually use consistently.
That usually means standardized templates, built-in compliance guardrails, and a system flexible enough to fit how you work.
Kivo helps quality teams stay inspection-ready without drowning in disconnected documents. Whether you’re auditing three vendors or 300, we can help you streamline the process without sacrificing compliance. Click below to demo our system and see why so many small-to-midsized life sciences teams are switching to Kivo's intuitive platform.
