Every vial accounted for, every log in its place.

The controlled repository for pharmacy-level study documentation: investigational product receipt and accountability, dispensing and cumulative dispensing logs, storage temperature records, cold-chain verification, equipment calibration certificates and, where applicable, environmental monitoring. It is the pharmacy’s own record of how it handled the product, and the file examined when an inspector visits the pharmacy.

The same controls applied to a different file. eISF holds the investigator site file — protocol, approvals, consent, delegation and monitoring evidence. ePSF holds the pharmacy site file — IMP accountability, dispensing, storage and calibration. Both use the same folder-structure principles, placeholder statuses, signature rules and readiness arithmetic, but are configured with different default templates. A study may run both, each from its own template and reference date.

Receipt, dispensing, return and destruction are each expected documents with their own milestone codes and due dates. The cumulative dispensing log is a tracked placeholder rather than a spreadsheet, and every entry carries the user and timestamp that produced it. Reconciliation is therefore continuous, not an exercise performed before a monitoring visit.

A daily storage temperature log is a recurring placeholder with its own due date and named owner. Where an excursion occurs, an ad-hoc placeholder records it, and a CAPA can be raised directly from the document’s action menu carrying the study, category and record with it. The excursion, the action taken and its closure sit on one trail.

Calibration certificates — fridge and freezer probes, balances and scales — are placeholders with annual due dates calculated from the last certificate. The named owner is notified seven days ahead of the due date, on the date, one day after and seven days after. A lapsed certificate shows as Overdue against the pharmacy readiness figure.

Fulfilled placeholders divided by applicable placeholders. Applicable is everything the study expects of the pharmacy at its current phase, less any placeholder waived with a recorded reason — for example environmental monitoring at a site performing no aseptic preparation. Both calculations display on the dashboard alongside the figures.

Yes. Roles are configured in Role Management with grouped ISF/PSF permissions, and a user may be scoped to the pharmacy binder alone. Restricted folders remain visible only to named users, and every access is attributable.

Yes. One template may be applied across every pharmacy, or a distinct template and reference date assigned per site. The cross-site matrix presents every pharmacy against the same milestones, and phase advancement waits until the outstanding list is cleared at all of them.

Connected Intelligence organises records, proposes where an upload belongs, surfaces documentation gaps and detects quality signals early. Every suggestion is reviewed by an individual. Authority over signature, certification, record closure and phase advancement rests with the responsible user. UK-hosted and aligned with NHS DSPT expectations.

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 already published there. Cost depends on the modules taken and the number of pharmacies covered, so we quote against your configuration. Trial periods are agreed case by case.