Life sciences and pharma
Commissioning and qualification software for facilities that have to prove every system before product touches it.
Pharmaceutical, biologics and advanced therapy facilities are not handed over on mechanical completion — they are released on evidence. Deskely holds the equipment register, FAT and SAT records, commissioning checks and IQ, OQ and PQ protocols in one system, so the qualification state of every vessel, skid, room and utility loop is visible while the work is happening rather than reconstructed for the regulator.
Choose your project type
The problem
Qualification evidence that lives in binders.
The engineering scope finishes months before the validation scope does, because commissioning data and qualification data are captured in different systems by different teams — and only one of them is auditable.
Commissioning and qualification are captured twice
The same pump, vessel or AHU is checked once by the commissioning contractor and again by the validation team, because the first set of records was never written in a GMP-acceptable form.
Protocol execution stalls on paper
IQ, OQ and PQ protocols circulate as printed packs, so a single missing initial or an uncorrected transcription error holds the whole package until a review cycle catches it.
Deviations are hard to see across the project
Discrepancies raised during execution sit inside individual protocol packs, so nobody can say how many are open against a room, a utility loop or a whole suite.
Data integrity is proven by handwriting
ALCOA+ expectations — attributable, legible, contemporaneous, original and accurate — are difficult to demonstrate when the record is a scanned page signed days after the test.
What you get
One register from FAT through release to GMP.
Model the facility as equipment, rooms, utility loops and systems, then run commissioning and qualification against the same tags with electronic signatures and a full audit trail.
Equipment and room register
Vessels, skids, isolators, AHUs, cleanrooms and utility loops held under change control, with the system and suite hierarchy the validation master plan expects.
Learn moreFAT, SAT and commissioning records
Vendor FAT results and site acceptance checks captured against the asset so good engineering practice work can be leveraged into qualification instead of repeated.
Learn moreIQ, OQ and PQ protocol execution
Protocols templated once per equipment type and executed on tablets in the field, with attributable, contemporaneous entries and electronic signatures.
Learn moreDeviations and punch that gate release
Discrepancies raised at the tag with photos and categories, so items that block qualification actually block the certificate beneath them.
Learn moreCleanroom and utility qualification
Pressure cascade, particle count, WFI, clean steam and compressed gas loop results recorded per room and per use point, rolled up to the suite.
Learn moreTurnover packages and release certificates
System turnover packages and release-to-GMP certificates assembled continuously from signed records, exportable for internal QA or an inspection.
Learn moreHow it runs
From factory acceptance to release to GMP.
- 01
Register and plan
Equipment lists, P&IDs and room schedules become a reviewed register aligned to the validation master plan and system impact assessment.
- 02
FAT, SAT and commissioning
Vendor and site checks are signed against each asset in a GMP-acceptable form so the work can be leveraged into qualification.
- 03
IQ, OQ and PQ execution
Protocols are executed in the field with contemporaneous entries, deviations raised at the tag and closed with evidence.
- 04
Release to GMP
Turnover packages and qualification summary evidence are exported per system, ready for QA release and inspection.
Side by side
Binders versus a single qualification record.
In a pre-approval inspection the question is not whether the work was done — it is whether the record proves it, and how quickly you can find it.
| Aspect | Protocol binders and spreadsheets | Deskely |
|---|---|---|
| Commissioning data | Repeated by the validation team in a second format. | Captured once, GMP-acceptable, leveraged into qualification. |
| Protocol status | Known only when a binder comes back for review. | Live per protocol, per asset, per system. |
| Deviations | Trapped inside individual packs. | Raised at the tag and visible across rooms and suites. |
| Data integrity | Handwritten entries signed after the fact. | Attributable, contemporaneous entries with an audit trail. |
| Cleanroom evidence | Certificates filed separately from the room. | Held against the room and its pressure cascade. |
| Inspection readiness | A retrieval exercise across shelves and drives. | An export from the system that already holds it. |
What changes
Once
capture from FAT through PQ
Per room
cleanroom and utility evidence
Live
deviation and punch visibility
On demand
inspection-ready qualification packages
Before you shortlist
Estimate what your current process costs
Enter your tag count and record handling time to see the admin hours and cost in play — then book a demo against your own numbers.
FAQ
Questions about life sciences and pharma.
Project types
The same CQV ladder, from an isolator FAT to a signed PPQ batch.
What changes between fill-finish, biologics, oral solid dose and the rest is the equipment breakdown, the GAMP 5 risk category and which regulator's expectations apply. The record types, the gates and the ALCOA+ audit trail behind them do not.
Sterile fill-finish CQV
A sterile fill-finish suite is one of the highest-scrutiny builds in pharma: restricted access barrier systems or isolators, filling lines, cappers, lyophilisers and the grade A/B/C/D cleanroom envelope around them all have to be commissioned, qualified and shown to hold environmental classification before a single vial can be filled for process performance qualification (PPQ). Deskely holds every piece of equipment, room and utility tie-in in one register with IQ, OQ, PQ and EU GMP Annex 1 contamination control evidence built in.
See this scope in detailBiologics drug substance CQV
A biologics drug substance facility runs upstream cell culture through bioreactors and downstream purification through chromatography, TFF and virus filtration skids, increasingly built around single-use technology that changes assembly-to-assembly. Deskely holds every bioreactor, skid, single-use assembly and clean utility tie-in in one register with IQ, OQ, PQ and GAMP 5 automation qualification gates built in.
See this scope in detailOral solid dose manufacturing CQV
An oral solid dose (OSD) line moves powder through granulation, blending, compression, coating and packaging, each stage with its own equipment qualification, in-process control and cleaning validation requirement. Deskely holds every piece of equipment, cleaning procedure and packaging line component in one register with IQ, OQ, PQ and process validation gates built in.
See this scope in detailCell and gene therapy facility CQV
A cell and gene therapy (CGT) facility is built around small, flexible, often single-patient batches, closed and functionally-closed processing systems, viral vector production suites and cryopreservation chains where chain-of-identity and chain-of-custody are as critical as the equipment qualification itself. Deskely holds every closed system, vector production skid and cryogenic asset in one register with IQ, OQ, PQ and chain-of-identity evidence gates built in.
See this scope in detailAPI and chemical synthesis facility CQV
An active pharmaceutical ingredient (API) plant is a chemical process facility held to GMP rigour: reactors, distillation and crystallisation trains, centrifuges, dryers and solvent recovery systems, each with hazardous area classification, process safety and cleaning validation requirements layered on top of standard equipment qualification. Deskely holds every reactor, vessel, hazardous area zone and utility tie-in in one register with IQ, OQ, PQ and process safety evidence gates built in.
See this scope in detailVaccine manufacturing facility CQV
Vaccine manufacturing spans antigen production, inactivation or attenuation, formulation and often high-speed fill-finish, frequently under pandemic-response timelines where the CQV programme is compressed but the evidence bar does not move. Deskely holds every bioreactor, inactivation skid, formulation vessel and fill line asset in one register with IQ, OQ, PQ and biosafety containment gates built in.
See this scope in detailCleanroom and HVAC qualification
A GMP facility's cleanroom envelope is a system in its own right: air handling units, HEPA filtration, pressure cascades, temperature and humidity control, and the rooms themselves all have to be commissioned, qualified and classified to ISO 14644 and EU GMP grade requirements before any manufacturing activity begins. Deskely holds every room, AHU and pressure zone in one register with IQ, OQ, PQ and ongoing environmental monitoring gates built in.
See this scope in detailClean utilities qualification — WFI, clean steam and process gases
Clean utilities are the invisible backbone of a GMP facility: water for injection (WFI) or purified water loops, clean steam generation for sterilisers and SIP cycles, and process gas systems (nitrogen, compressed air, CO2) feeding every use point in the plant. Deskely holds every generation skid, distribution loop and use point in one register with IQ, OQ, PQ and ongoing water quality monitoring gates built in.
See this scope in detailLab and R&D facility CQV
A pharma R&D or QC lab lives or dies on the qualification status of its analytical instruments, containment devices and lab utilities: HPLCs, mass spectrometers, fume hoods, biosafety cabinets, incubators and lab gas systems all need IQ/OQ/PQ and periodic requalification before the data they generate can support a regulatory submission. Deskely holds every instrument, containment device and utility tie-in in one register with GAMP 5 computerised system validation and 21 CFR Part 11 evidence gates built in.
See this scope in detailCold chain and warehouse qualification
Pharma cold chain and warehouse operations depend on mapped, monitored and alarmed storage and distribution, from ambient and refrigerated warehouse zones through ultra-low freezers to the refrigerated vehicles and lanes that move product between sites. Deskely holds every storage zone, freezer, vehicle and monitoring point in one register with temperature mapping, GDP compliance and alarm response evidence gates built in.
See this scope in detail