Validation Support Pack — IQ / OQ / PQ Templates

1. Purpose

To document that Aliquora is installed correctly for your organization (IQ), operates according to its specified functions (OQ), and performs reliably for your intended laboratory use (PQ).

2. Scope

This protocol covers the Aliquora LIMS as configured for your organization, including the functions in scope for your workflows (sample management, results entry, review/approval, electronic signatures where licensed, reporting, export, and access control). Define exclusions here.

3. Responsibilities

• Validation lead — owns the protocol, schedules execution, and approves results.
• Executors (testers) — perform each test case and record actual results and evidence.
• Quality assurance — reviews and approves the completed protocols.
• System administrator — provides configuration details and account setup.

4. Prerequisites

• Approved validation plan and acceptance criteria.
• Configured organization, plan/features, and user accounts with assigned roles.
• Representative test data (material types, tests with spec limits, sample records).
• Access to a recent instrument export for import testing (PQ).
• Recorded application version/build identifier from IQ-05.

5. Installation Qualification (IQ)

Confirms the environment and configuration are correctly established before functional testing.

ID	Test step	Expected result	Actual result	Pass / Fail	Initials / date
IQ-01	Confirm the production URL loads over HTTPS and presents a valid TLS certificate.	Site loads over HTTPS; certificate is valid and not expired.
IQ-02	Confirm your organization (tenant) exists and is named correctly.	Organization record is present with the agreed name and plan.
IQ-03	Confirm the subscription plan and enabled features (e.g. electronic signatures, approval workflows) match the order.	Plan and feature flags match the signed order/quote.
IQ-04	Confirm administrator and initial user accounts are created with the correct roles.	Each account exists with the intended role; no unexpected accounts.
IQ-05	Record the application version / build identifier shown in the product.	A version/build identifier is recorded for this validation baseline.
IQ-06	Confirm supported browsers/devices for your users can reach and render the application.	Each in-scope browser/device loads the application without error.

IQ acceptance criteria: All IQ test cases pass. Any deviation is documented, assessed for impact, and resolved or justified before OQ begins.

6. Operational Qualification (OQ)

Confirms that the application's functions operate as specified across security, data integrity, and core workflow.

ID	Test step	Expected result	Actual result	Pass / Fail	Initials / date
OQ-01	Log in with a valid account; then attempt login with an incorrect password repeatedly.	Valid login succeeds; repeated failures trigger account lockout.
OQ-02	As a read-only user, attempt an action reserved for a higher role (e.g. enter a result).	Action is blocked; authority check is enforced server-side.
OQ-03	Create a material type, a test definition with spec limits, and a sample with tests.	Records are created and retrievable with the entered values.
OQ-04	Enter a result within spec, then a result outside the spec limit.	In-spec result is accepted; out-of-spec result is automatically flagged.
OQ-05	Verify a result, then attempt to edit it without unlocking.	Edit is blocked (locked record returns a conflict).
OQ-06	As an administrator, unlock the verified result (password re-auth + reason), then review the audit trail.	Unlock requires password and a reason; an audit entry records who, when, and why.
OQ-07	Apply an electronic signature (if enabled); confirm the password prompt and signature meaning.	Signing requires re-authentication and captures signer, timestamp, and meaning.
OQ-08	Change the signed record and re-open the signatures list.	Signature verification flags the record as changed (tamper-evident).
OQ-09	Generate a Certificate of Analysis (PDF) and export samples/results/audit log to CSV.	PDF and CSV exports are produced; export is recorded in the audit trail.
OQ-10	Log in as a user from a different organization (or confirm scoping in test data).	No data from another organization is visible (tenant isolation).

OQ acceptance criteria: All OQ test cases pass. Failures are logged as deviations, investigated, and either corrected and re-tested or justified with QA approval before PQ.

7. Performance Qualification (PQ)

Confirms the system performs reliably for your real, day-to-day laboratory use over a defined trial period.

ID	Test step	Expected result	Actual result	Pass / Fail	Initials / date
PQ-01	Run one full real workflow end to end: receive a sample, prepare, enter results, review, approve, report.	The sample progresses through every status and produces a correct COA.
PQ-02	Have each role perform its routine daily tasks for a defined trial period.	Each role can complete its tasks; no permission gaps or blockers found.
PQ-03	Import a representative batch of results from your instrument export.	Results map to the correct samples/tests; mismatches are flagged for review.
PQ-04	Reconcile a day of records against the audit trail and any parallel paper/spreadsheet records.	Records and audit trail agree; no unexplained discrepancies.
PQ-05	Confirm reports/COAs meet your reporting SOP (content, layout, sign-off).	Reports satisfy the laboratory's reporting requirements.

PQ acceptance criteria: All PQ test cases pass over the trial period with no unresolved data-integrity or workflow defects. Residual risks are documented and accepted by QA.

8. Deviation log

Deviation #	Description	Impact & resolution	Approved by / date

9. Summary & approval (sign-off)

On completion, summarize the outcome of each protocol and record the validation decision. By signing, the approvers confirm the protocol was executed as written, the evidence supports the results, and the system is approved for its intended use (or approved with documented conditions).

Role	Name	Signature	Date
Executed by
Reviewed by
QA approval