Compliance maintained as a daily state, not a pre-audit scramble.
The quality management system for NHS Trusts, research networks, academic units and CROs. Every controlled document carries its own review cycle, training assignment and audit trail — compliance calculated straight from the record, not assembled from three systems before a monitor arrives.
Three silos, one quality team trying to hold them together.
The controlled copy and the one in the shared drive disagree
A revised SOP is approved, but the version on the ward, in an inbox, or on a laptop is the one staff are actually reading.
Reading assignments are chased by email, not tracked as a record
A quality lead re-sends the same reminder to the same list, with no record of who has genuinely read the current version.
Competency is assumed, not evidenced
A signature on a training log proves attendance at a session, not that the attendee could answer a question about it afterwards.
Leadership finds the gap at inspection, not before it
Without one governed view, compliance is a status no one can state with confidence until an inspector asks for proof.
Nine controls across the document lifecycle, one governed record.
Each workspace writes to, and reads from, the same controlled-document record — from first draft to the certificate a researcher holds at the end.
My Vault
Where a controlled document begins — draft, upload, check in and out, and hold the discussion against the document itself.
Shared With Me
Every document sent to you for review or approval, with the cycle’s history attached.
Quiz Manager
A reusable question bank and the quizzes built from it, linked to documents to turn a read into verified competency.
Publish Documents
The final gate. Only documents that have cleared approval appear here, released with their assignment configured first.
Document Library
The single current version of every published document, with learning progress and access held against it.
Document Control
Organisation-wide oversight — every document’s stage, owner and dates, with transfer and archiving under re-authentication.
My Learnings
A researcher’s own assigned reading and knowledge checks, with a certificate issued on passing.
Dashboard
Compliance across the whole organisation, in six views — including Pending Focus for the biggest backlogs.
Reporting
Compliance, pending-work and document-trend reports, grouped and filtered, exported for governance packs.
From first draft to a certificate on record.
One document, four stages, four workspaces — each with Connected Intelligence drafting the work and a named user deciding. Select a stage to follow SOP-014 through it.
Home / My Vault
SOP-014-V3.2 · v3.2 · Owner M. Coulson
DraftThe document is uploaded to My Vault as a draft. AQ builds its ID from the type, category and unique number you enter, then reviewers and approvers are added and a quiz can be linked from Quiz Manager.
Each review cycle records who it was sent to and when they completed it, with CURRENT and PAST cycles kept side by side. The approver acts once every review is in — both actions requiring re-authentication.
Only approval-completed documents reach Publish Documents. My Learning, Library access and the review-due date are configured in order, and each step must be saved before moving on.
Each assigned reader opens the current version from My Learnings, confirms the read, and answers the linked quiz to the pass mark. A certificate is issued and compliance recalculates immediately.
The SOP a reviewer approved is the SOP every assigned member of staff actually reads.Four roles, four workspaces, one document that never leaves the record.
Each role acts in its own workspace and hands the document to the next. Nothing is re-sent, re-keyed or chased between them.
Compliance you can interrogate, not just quote.
The Dashboard summarises. Reporting turns the same underlying record into the exact slice a governance meeting or an inspector asks for.
A shared drive, an inbox and a spreadsheet answer to no one until the monitor arrives.
Controlled documents on a shared drive, approvals chased over email, training tracked in a spreadsheet, competency checks on paper — none of it reports its own state, and none of it agrees with the others by the time anyone checks.
MHRA inspection findings repeatedly cite investigational product accountability and storage records — the documentation most often held on paper, and the least able to report its own state.
“Every SOP, every read, every sign-off sits against one record. When a monitor asks who was trained on what, we open the document rather than reconstructing three months of email.”
One controlled quality system for documents, training and CAPA — adopted across many departments by more than 300 people.
Three ways to look deeper into AQ QMS.
The module guide, how AQ compares against other clinical software, and a guided tour of the platform.
Questions quality teams ask.
Not covered here? Write to us at enquiries@aq-trials.com.
Either. Mandatory reading and the quiz requirement are two independent settings on publish — a document can require acknowledgement only, a quiz only, or both. If the quiz toggle is on with nothing linked, publishing is blocked until one is attached.
Yes. Document type, category and your own unique numbering scheme are entered at upload, and AQ builds the document ID from them — nothing is renumbered to fit the system.
Superseded versions are retained and remain viewable, but every workspace tab — reviewers, approvers, comments, the audit log — stays with the current version, so there is one active record per document, not a fork per revision.
Each acknowledgement and each quiz result is a permanent, attributable record — who, what version, when, and the score if a check was required — exportable from Reporting or from the document’s own audit log.
No — it connects to it. A quality issue found against a controlled document can be raised as a CAPA directly from that document, with the module, study and document reference already filled in.
Roles are configured by the System Administrator, and each action is separately permissioned. Completing a review, recording an approval, publishing, transferring ownership and archiving are all authenticated actions — password, access code and a stated reason, recorded against the named user who took it.
Completed reads divided by total assigned activity. Waived reads leave the assigned count with a reason on the record, and the figure recalculates as each acknowledgement or quiz result lands — so the number a quality lead works to is the number an inspector is shown.
Yes. My Learning assignment and Library access are configured at publish by staff role or by named individual, and reminders follow the same assignment. A new starter in an assigned role picks up the required reading without anyone re-issuing it.
AQ sits on the Digital Marketplace under G-Cloud, so a Trust can call off against the framework instead of running a full tender; pricing, service definition and exit terms are published there. Cost reflects the modules taken and the size of the staff base, so we quote against your configuration.
Yes. QMS runs on its own, and connects to CTMS, eISF, ePSF, CAPA and Digital DoA on the same record if and when those are adopted. Nothing about the document-control workflow depends on the other modules being in place.
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