Commissioning, qualification and validation software for lab and R&D facilities where analytical instruments, fume hoods, biosafety cabinets and lab utilities all have to be qualified before a single GxP data point can be trusted.

A QC or R&D lab accumulates analytical instruments, fume hoods, biosafety cabinets and lab utilities over years, each on its own requalification cycle, with computerised systems attached to many of them requiring their own GAMP 5 validation.

When instrument qualification certificates, computerised system validation records and requalification schedules sit in separate lab notebooks and a facilities spreadsheet, nobody can confirm which instrument is actually in a qualified state before it generates data for a regulatory submission.

Deskely tags every instrument, containment device and computerised system individually, so qualification status — and the next requalification due date — is visible per asset instead of tracked in a shared calendar nobody owns.

New instruments undergo IQ, OQ and PQ against their URS, with computerised system validation executed for any attached software or data system per its GAMP 5 category before the instrument is released for GxP use.

Fume hoods and biosafety cabinets are certified on their own schedule — face velocity, HEPA integrity and airflow pattern — with certification stickers and digital records both tied to the same tag, so a lapsed certification is visible before it becomes a data integrity finding.

Requalification due dates are tracked continuously against every instrument and containment device, surfacing overdue items before they are used rather than discovering the gap during an audit.

Analytical instruments increasingly run on vendor-controlled software and firmware that update independently of the lab's own change control calendar. A version change to instrument control software, integration software or a LIMS interface can alter calculation logic, audit trail behaviour or data formats in ways that a GAMP 5 computerised system validation is specifically designed to catch — if it is triggered.

When the update happens outside the lab's own tracking, the instrument keeps generating data under the assumption that its CSV status is unchanged, and the gap is usually found retrospectively, during an audit, rather than before the next batch of results is trusted.

Deskely ties each instrument's computerised system to its software version, so a version change flags the instrument for revalidation before further GxP data is accepted from it, and the CSV history for every version the instrument has run under stays attached to the same tag.