Validation Package

The Validation Package dashboard provides tools for generating, managing, and tracking compliance documentation required for computer system validation (CSV). It supports the complete validation lifecycle from planning through execution and release.

Auto-Generated Validation — No Manual IQ/OQ/PQ Needed

Traditional computer system validation requires months of manual document authoring for VMP, URS, IQ, OQ, PQ protocols, and traceability matrices. InnoQualis auto-generates all of these based on your workspace configuration, industry selection, and compliance framework. Select Generate Full Package and receive a complete, regulation-ready validation package in minutes — not months. Zero consultant fees, zero manual protocol writing.

Open the Validation Package dashboard

1. On the left sidebar, select Admin.
2. In the admin sidebar under System, select Validation Package.

The dashboard loads with a status banner, document type cards, validation execution tools, compliance management sections, and a recent packages table.

Understand the validation status banner

At the top of the dashboard, a status banner shows the current validation state and key metrics:

Status	Meaning
Passed	All tests executed and passed with 100% pass rate
In Progress	Some tests have been executed but not all
At Risk	Failed tests or critical deviations exist
Not Started	No tests have been executed yet

The banner also displays total tests, executed count, passed count, failed count, pass rate, and open deviations count. A progress bar visually represents the ratio of passed, failed, and pending tests.

Document types

The dashboard displays cards for each validation document type:

Document Type	Description
Validation Master Plan (VMP)	Master plan defining validation strategy, approach, and activities
User Requirements Specification (URS)	Specification of functional, non-functional, and regulatory requirements
Vendor Qualification (VQ)	Questionnaire for vendor qualification and compliance assessment
Validation Summary Report (VSR)	Summary report of validation activities and test results
IQ/OQ/PQ Protocols	Installation, Operational, and Performance Qualification protocols
Traceability Matrix	Matrix mapping requirements to test cases for coverage verification
System Overview	High-level system description and architecture documentation
Configuration Specification	Detailed configuration specifications and settings

Each card shows the document name, description, generation status badge, last generation date (if applicable), a Generate button, and a Download button (if already generated).

Generate a single validation document

1. On the dashboard, find the document type card you want to generate.
2. Select Generate.
3. On the document-specific generator page, configure any generation options.
4. Select Generate to create the document.
5. Generation runs in the background so the app stays responsive while the documents render. Watch the generation status badge on each card; once complete, the document appears in the Recent Packages table at the bottom of the dashboard and its Download button becomes available. Generate Full Package works the same way — it starts the full set generating and you can leave the page while it completes.

Signing a generated document

For every document type — VMP, URS, VSR, IQ/OQ/PQ, VQ, System Overview, Configuration Specification, and Traceability Matrix — a successful generation opens a Generated Document & Signatures panel on the same page (in addition to the dashboard card’s Download button). From there you can download the document and select Apply Signature to add an electronic signature (Author, Reviewer, Approver, or QA Approver) verified with a one-time code sent to your email, per 21 CFR Part 11.

Traceability Matrix coverage gate

The generator opens pre-populated with your organization’s real data: the requirements from your most recently generated User Requirements Specification (URS), plus any requirement ID referenced by an active Test Case that isn’t already in that URS, on the requirements side; your active Test Cases (from Test Cases under Validation Execution) on the test side. If you haven’t generated a URS or created any Test Cases yet, the page tells you so instead of showing placeholder rows — add data on those pages first, or add rows here by hand.

You can still add, remove, or re-map rows before generating, and the coverage gate applies to whatever the page shows at generation time (your edits included): generating a Traceability Matrix is blocked when one or more requirements have no test mapped to them. If any requirement is uncovered, selecting Generate Traceability Matrix opens an Incomplete Coverage dialog listing the uncovered requirement IDs.

You have two paths from the dialog:

• Cancel — close the dialog, add the missing test mappings, then try again. This is the right path for production validation packages, where 100% coverage is an acceptance criterion.
• Override & Generate — admins can bypass the gate when an audit needs to ship anyway (for example, recording a known gap during remediation planning). The override is recorded in the audit trail with the literal marker COVERAGE OVERRIDE and the list of uncovered requirement IDs, so reviewers can find every overridden run.

The same enforcement applies at the API: POST /api/validation-package/traceability-matrix returns 422 with {"code": "incomplete_coverage", "uncovered_requirement_ids": [...]} unless the request includes "force": true.

Generate a full validation package

1. On the dashboard, select Generate Full Package in the top-right corner.
2. Monitor progress on the generation page.
3. Once complete, all documents are available as a unified package.

Manage test cases

1. On the dashboard, in the Validation Execution section, select Test Cases.
2. Create test cases with descriptions, expected results, and linked requirements.
3. Organize test cases by qualification type (IQ, OQ, PQ).

Requirement ID, Title, Description and Expected result are required. If you submit with any of them empty, a message appears beneath that field and nothing is sent until you fill it in.

Execute manual tests

1. On the dashboard, in the Validation Execution section, select Manual Tests.
2. Select a test case to execute.
3. Follow the test steps and record actual results.
4. Attach evidence (screenshots, logs) as needed.
5. Mark each test step as passed or failed.

Attached evidence files stay private to your organisation: only its administrators can download them, and each download is named after the file you uploaded. Evidence attached before integrity records were introduced (August 2026) is not downloadable until it is re-attached.

Run automated tests

1. On the dashboard, in the Validation Execution section, select Automated Tests.
2. Select the test cases to run automatically.
3. The system executes tests and uses AI analysis to evaluate results.
4. Review automated test results and evidence.

Track deviations and CAPA from testing

1. On the dashboard, in the Validation Execution section, select Deviations & CAPA.
2. View open deviations with severity classifications.
3. Perform root cause analysis.
4. Create and track corrective and preventive actions.

Title and Description are required when you report a deviation; an empty field is flagged beneath the field on submit.

Note

Deviations with “Critical” severity change the overall validation status to “At Risk” regardless of test pass rate.

Deviations here are QMS deviations

A deviation raised from validation testing is a full record in the QMS Deviations register — not a separate, validation-only list. It goes through the same approval workflow and electronic-signature requirements as any other deviation, and shows up in the register filtered to Source: Validation. Each row on this page links to its QMS record (“View in QMS register”) so a QA reviewer never has to look in two places to see every open deviation for the tenant.

A deviation raised before this change kept its original DEV-### number as a visible legacy reference (shown alongside the row) — no existing identifier was renumbered when the two registers were unified.

Review GAMP 5 compliance

1. On the dashboard, in the Compliance section, select GAMP 5 Compliance.
2. Review the system’s GAMP 5 Category 4 classification, lifecycle phases, and validation status.

Review ISO 27001 compliance

1. On the dashboard, in the Compliance section, select ISO 27001 Compliance.
2. Review control status by domain.
3. Identify and address compliance gaps.

The dashboard is a self-assessment against ISO/IEC 27001:2022 Annex A (4 themes — Organizational, People, Physical, Technological — 93 controls), shown on the page next to the compliance statement. It is not an audited or certified conformance claim (certification_status always reads “Not Certified”).

Controls carried over from the platform’s prior 2013-edition-based self-assessment keep their previously recorded status under their corrected 2022 control ID. Controls introduced by the 2022 revision, which the platform never made a prior claim about, show as Not Assessed rather than being assumed implemented — expect the reported compliance percentage to be lower than a dashboard that (incorrectly) marked everything implemented by default.

Manage the release log

1. On the dashboard, in the Compliance section, select Release Log.
2. Create new release entries with version numbers and descriptions.
3. Document validation impact for each release.
4. Track release history chronologically.
5. Correct an existing entry with Edit — the change log and validation-impact text of a recorded release can be amended in place.

Release logs are private to your organisation, and version numbers are scoped to it: two organisations can each record version 2026.4.0 without colliding.

View recent packages

The bottom of the dashboard displays a table of recently generated packages:

Column	Description
Package Type	The type of validation document
Version	Version number of the package
Status	Completed, Processing, Failed, or Pending
Artifacts	Number of generated artifacts in the package
Created	Generation date
Actions	View details, Export compliance evidence

Select View details to open a package’s own page, listing every generated document (artifact) it contains. From there, Download ZIP downloads the whole package as a single archive built on the server; each artifact also has its own Download button if you only need one document.

Export compliance evidence

1. In the Recent Packages table, on the package row, select Export.
2. A ZIP file containing compliance evidence in CSV format downloads to your computer.

Use exported evidence for regulatory submissions and audits. The 05_signatures.csv sheet lists every active electronic signature on the package with its Integrity verdict and Signature Hash (see below).

Electronic signature integrity

Every electronic signature applied in the Validation Package — on a generated document, or when approving an automated test run — is sealed at signing time with a SHA-256 hash of what was signed: the signer, the signature meaning, the time, and the record itself (the document’s content checksum, the package’s artifact checksums, or the run’s formal test-execution results). The hash is checked every time signatures are read, and each signature reports one verdict:

Integrity	Meaning
valid	The signature and the record it covers are unchanged since signing.
invalid	The signature, its meaning, or the signed record was altered after signing. The signature panel flags it as Integrity failed. Treat the record as unverified and investigate through the audit trail.
unhashed_legacy	Signed before integrity hashing existed. It cannot be verified and is never reported as valid. Re-sign a document to seal it; an automated-run approval made before hashing existed stays unverified.

The verdict appears in the signature panel and in the Integrity column of 05_signatures.csv in the exported compliance evidence. It also appears:

• On the generated Validation Summary Report (VSR) document itself: its Signatures table carries an Integrity column for every signature, and the document adds a warning banner plus a legend explaining the three verdicts whenever any signature on it reads invalid — the failure is visible to anyone who opens the exported document, not only to someone checking the signature panel.
• On the Automated Tests approved-run banner: once a test run is approved, the banner showing “This test run has been approved with electronic signature” adds a line reporting the same three-state verdict for that approval’s signature.

Permissions

Action	Required Permission
View validation dashboard	Admin role
Generate validation documents	Admin role
Execute tests	Admin role
Manage deviations	Admin role
Export compliance evidence	Admin role

Tip

Generate validation documents after significant system changes or before regulatory audits. Regenerate documents when requirements change or new features are deployed.

Practical example: Prepare a complete validation package for an FDA pre-approval inspection

Your company has an FDA pre-approval inspection scheduled and needs to demonstrate that the eQMS is validated per 21 CFR Part 11 and GAMP 5 guidelines.

1. Open Admin > System > Validation Package.

2. Review the status banner. If it shows “Not Started”, begin by generating the full package.

3. Select Generate Full Package in the top-right corner. The system auto-generates all eight document types from the table above, including:

   • Validation Master Plan (VMP) — populated with your workspace’s industry, compliance frameworks, and validation strategy.
   • User Requirements Specification (URS) — derived from your configured workflows, form templates, and system capabilities.
   • IQ/OQ/PQ Protocols — test cases auto-generated from your system configuration (e.g., verifying that approval workflows enforce the correct number of signatures, that audit trails capture all required fields).
   • Traceability Matrix — automatically linking each URS requirement to its corresponding test cases.
   • Vendor Qualification (VQ), Validation Summary Report (VSR), System Overview, and Configuration Specification — rounding out the package with the remaining four document types.

   Each checkbox on the Generate Full Package form controls one document type; every type is included by default and can be individually excluded.

4. Navigate to Test Cases under Validation Execution. Review the auto-generated test cases and add any site-specific tests.

5. Select Automated Tests and run the full suite. The system executes tests against your live configuration and uses AI analysis to evaluate results.

6. For any failed tests, navigate to Deviations & CAPA to document the finding and corrective action.

7. Once all tests pass, review GAMP 5 Compliance to confirm Category 4 classification status.

8. In the Recent Packages table, select Export to download a ZIP containing all compliance evidence.

Present the exported package to the FDA inspector. It contains a complete validation lifecycle — from planning through execution and release — with tamper-evident audit trails for every action. What traditionally takes 3-6 months of manual effort is generated and executed in a single session.