Compliance & Onboarding Kit

Regulated-Lab Onboarding Checklist

Aliquora

aliquora.com

A phase-by-phase checklist for standing up your Aliquora instance — from governance and roles through test catalog, QC criteria, data migration, validation, and go-live. Print it (or save as PDF), work through it top to bottom, and initial each item as you complete it.

Document type

Checklist (printable)

Phases

Owner

System owner + QA

Who this is for. New labs onboarding onto Aliquora — especially regulated labs (pharma GMP, clinical, accredited environmental) that need a documented, orderly setup. Phases 1–5 and 7 apply to every lab; Phase 6 (validation) applies where your regulations require computer-system validation. Pair this checklist with the Shared-Responsibility Guide so the division of duties is clear before you start.

Phase 1 — Plan & governance

Decide who owns the system and what it will be used for, before anyone configures anything.

Done	Task	Suggested owner	Initials / date
	Name a system owner (day-to-day admin) and, for regulated use, a validation lead in QA.	Lab management
	Write a one-paragraph intended-use statement: which workflows, which record types, which regulations apply.	QA / validation lead
	Read the Shared-Responsibility Guide and note which activities your lab must own (validation, SOPs, training, retention).	QA / validation lead
	Decide your go-live approach: parallel run alongside the current system, or a hard cutover date.	Lab management

Phase 2 — Organization, roles & security

Stand up the account structure and access control that everything else depends on.

Done	Task	Suggested owner	Initials / date
	Register your organization and confirm the plan and enabled features match what you purchased.	System owner
	Create user accounts and assign roles (admin, technician, reviewer, read-only) matching real job duties — least privilege.	System owner
	If technicians should only see specific sampling locations, configure per-location assignments (optional; unassigned users see all).	System owner
	For Part 11-style signing, keep the signature password re-authentication setting enabled (it is on by default).	QA / validation lead
	Configure notification preferences per user (in-app, immediate email, daily digest) for alerts your SOPs rely on.	System owner

Phase 3 — Reference data & test catalog

Configure the catalog every sample and result will be evaluated against.

Done	Task	Suggested owner	Initials / date
	Create material types for everything your lab receives (matrices, product types).	System owner
	Build the test catalog: test codes, methods, units, specification limits, and turnaround days. Start from the bundled method/analyte reference library where it fits, and adapt it.	Lab manager / QA
	Configure holding times for methods where they apply (e.g. EPA Part 136 work), so approaching/expired analyses are flagged.	Lab manager
	Create projects and clients, and set up sample-submission fields per project if you use custom intake forms.	System owner
	Create sampling locations if your work is location-based (environmental, water systems, plants).	System owner
	Have a second person review the catalog against your methods and specs before first use — this is your data foundation.	QA

Phase 4 — QC configuration

Set up the QC controls that gate result release.

Done	Task	Suggested owner	Initials / date
	Define QC acceptance criteria per method (blanks, duplicates, spikes, standards) — criteria are snapshotted onto each QC batch when it is built.	QC officer / lab manager
	Review Levey-Jennings control charts and decide which Westgard rules matter for your methods; enable the QC control-chart alert if you want automatic notifications.	QC officer
	Decide your equipment out-of-calibration policy (off / warn / block) and record calibration and training status for instruments and analysts.	Lab manager
	Confirm the release gate behaves as expected: a failed QC batch must block validation, verification, and reporting of covered results.	QA

Phase 5 — Data migration

Bring in existing data in a controlled, verifiable way.

Done	Task	Suggested owner	Initials / date
	Download the CSV import templates (samples, material types, tests, bulk results) from the Documents page.	System owner
	Decide the migration scope: open/in-progress samples only, or historical records too. Less is easier to verify.	Lab management
	Import in order: material types → tests → samples → bulk results.	System owner
	Verify a sample of migrated records against source documents and record the verification (who checked, what, when).	QA
	Keep a copy of the source files and the import files as part of your migration record.	QA

Phase 6 — Validation (regulated use)

Document that the configured system is fit for your intended use. Aliquora is not delivered pre-validated — this phase is customer-executed.

Done	Task	Suggested owner	Initials / date
	Adapt the IQ/OQ/PQ templates from the Validation Support Pack to your intended-use statement and configuration.	Validation lead
	Execute IQ: confirm access, tenant, plan/features, accounts, and record the application version baseline.	Validation lead
	Execute OQ: exercise access control, OOS flagging, record locking/unlocking, e-signatures, exports, and audit-trail capture.	Testers + validation lead
	Execute PQ: run at least one real workflow end-to-end per role for a defined trial period.	All roles
	Review, approve, and file the completed protocols in your quality system; log any deviations.	QA

Phase 7 — Training, SOPs & go-live

Make it official.

Done	Task	Suggested owner	Initials / date
	Update or write the SOPs that govern system use: result entry, review/approval, OOS handling, record unlocking, audit-trail review, exports/retention.	QA
	Train every user on their role's workflows and keep training records.	Lab manager
	Run the parallel period (if chosen) and reconcile records between systems daily.	All roles
	Set the cutover date, communicate it, and retire or freeze the legacy system per your retention policy.	Lab management
	Schedule recurring housekeeping: periodic audit-trail review, account review, data exports for independent retention, and catalog change control.	System owner + QA