This checklist reverses that sequence. Use it before you schedule a single vendor demo. Work through each question internally first, so you know exactly what your compliance program requires. Then use the same questions as your vendor scorecard.

Download the full one-page PDF checklist below, or work through the questions directly on this page.

How to Use This Checklist

Score each vendor response as follows:

• 2 points: Vendor passes clearly, with documentation or a live demonstration to support the answer
• 1 point: Vendor passes with reservations, or the answer requires follow-up to confirm
• 0 points: Red flag triggered, or the question goes unanswered

A total score of 17-20 indicates a well-qualified platform. A score of 12-16 indicates gaps that require documented risk acceptance before selection. A score below 12 indicates the platform is likely to create more compliance overhead than it eliminates.

Section 1: Validation and Compliance

1. Does the vendor provide a complete validation package with every platform update?

Ask specifically for: Validation Plan, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), User Requirements Specification (URS), Traceability Matrix, and Summary Report. Confirm that the package covers the specific update version being deployed, not just the initial release.

Red flag: The vendor provides only a “validation guide” or a template, and expects your organization to execute all testing from scratch on every update.

2. Is the platform validated to FDA 21 CFR Part 11 and 21 CFR Part 820 (QMSR)?

Confirm which specific regulations are covered and ask for documentation of how each regulatory requirement is addressed within the platform architecture. A 21 CFR Part 11 compliance matrix should be available on request.

Red flag: The vendor claims “Part 11 compliant” but cannot provide a compliance matrix, references no specific clauses, or conflates Part 11 with ISO 13485 without distinguishing the requirements.

Section 2: System Architecture and Integration

3. Are CAPA, deviations, change control, document control, and risk management connected natively?

A CAPA should link automatically to the originating deviation, the associated risk record, and any triggered change control , without manual cross-referencing or custom development. Ask the vendor to demonstrate a live end-to-end scenario during the evaluation.

Red flag: Modules exist within the platform but records must be manually cross-referenced, or module linking requires configuration services.

4. Can the system integrate with your existing ERP, LIMS, or document storage infrastructure?

Ask for a current integration list, whether integrations are native or require a third-party connector, who owns the integration after go-live, and what happens to the integration when the vendor releases a platform update.

Red flag: Integration requires a separate paid connector, ongoing vendor involvement for every data exchange, or the integration breaks during platform updates.

Section 3: Configurability and Ownership

5. Can your quality team configure workflows without IT involvement or vendor tickets?

True no-code configurability means your QA team can modify approval sequences, add fields, create new record types, and adjust workflows in a development environment, then promote those changes to production without a developer or a vendor change request. Ask for a live configuration demonstration using your team’s hands, not the vendor’s.

Red flag: Any workflow change requires a vendor change request, a new statement of work, or an IT project. Configuration is done by the vendor on your behalf.

6. Does the platform support multiple environments (Dev, QA, Production) without additional cost?

Regulated organizations need at least three environments to follow proper configuration management practice: a development environment for building and modifying, a validation or QA environment for testing and executing validation protocols, and a production environment for end users.

Red flag: Additional environments are licensed separately, the vendor does not support environment separation, or promoting changes from QA to production requires vendor involvement.

Section 4: Audit Readiness and Data

7. Does the system generate a complete, exportable audit trail for every record and action?

The audit trail should capture who performed the action, when, from which device or IP address, and the before-and-after state of any changed field. It must be tamper-evident, meaning it cannot be modified by any user including system administrators.

Red flag: The audit trail cannot be exported in a human-readable format, requires elevated admin access to view, is stored separately from the records it references, or can be altered by any user role.

8. Can you produce a live quality dashboard with CAPA aging, deviation trends, and supplier metrics in real time?

Built-in analytics should pull live data from all modules without manual exports. During the evaluation, ask to see the analytics dashboard populated with real data, not a screenshot or a demo environment with placeholder numbers.

Red flag: Reporting requires data exports to Excel or a third-party business intelligence tool before any meaningful analysis can be performed. Dashboards are static rather than live.

Section 5: Implementation and Long-Term Ownership

9. What does the implementation timeline look like, and who owns the project after go-live?

Ask for a reference customer in your industry with a similar organizational size and scope. Confirm whether a dedicated customer success manager is included in the contract or an additional cost. Understand the vendor’s standard implementation methodology and what your internal team will be responsible for.

Red flag: The vendor cannot provide an industry-matched reference customer, post-go-live support is a separate paid tier, or the implementation methodology is undefined.

10. How does the vendor handle platform updates, and what is your re-validation obligation for each?

Platform updates should be pre-validated by the vendor, seamless, and included in your subscription at no additional cost. Your obligation per update should be limited to reviewing the vendor’s validation package, executing your organization-specific PQ scenarios, and documenting your approval.

Red flag: Every platform update requires a customer-initiated re-validation project spanning weeks of internal resources. Updates are infrequent, require scheduled downtime, or the vendor provides no validation documentation for updates.

Download the PDF Version

The one-page PDF version of this checklist is formatted for printing and use in vendor evaluation sessions. Bring it to every demo. Use it to score each vendor in real time.

Download the eQMS Evaluation Checklist (PDF)

About This Checklist

This checklist was developed by Emma Johnson, Quality Assurance Consultant at Cloudtheapp, based on evaluation conversations with Quality Directors and QA teams across pharmaceutical, medical device, biotechnology, and manufacturing organizations.

If you would like to work through this checklist with a structured Cloudtheapp walkthrough, schedule a consultation here. The session is diagnostic first — we ask the same questions about your compliance program before we show you anything about the platform.

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