Cell & Gene · Autologous · Allogeneic · COI · COC · Viral Vector
Cell and gene therapy manufacturing software with chain-of-identity and chain-of-custody checks at every handoff.
Autologous COI from apheresis to infusion, allogeneic lot genealogy from donor to bag, viral-vector eBR, ISBT 128 / SEC-178 in-record labelling and a signed Part 11 audit trail. The CGT platform that keeps the patient, the batch and the product bound at every step.
Chain-of-custody signed at every hop
Viral-Vector eBR
Cryo Cold-Chain Evidence
Real-time review-by-exception release
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
You're shopping for CGT manufacturing software because autologous COI on a spreadsheet is a patient-safety time bomb.
COI is enforced by convention, not by the system
Apheresis-to-infusion handoffs live in email attachments
Cryo-shipper temperature stream isn't bound to the product record
Viral-vector eBR is a Word template with e-signature bolted on
ISBT 128 / SEC-178 codes get retyped from another system
Lot release waits weeks for QC and QA to reconcile three systems
EMA Annex 2A / FDA Part 1271 Subpart D evidence is stitched together at inspection
The CGT workflow, modeled and enforced.
Chain-of-custody signed at every hop
Bound e-signature at every handoff — apheresis site, courier pickup, receipt at manufacturing, in-process, cryo, ship, thaw at infusion site.
Viral-Vector eBR
Plasmid banks, transfection, downstream purification, fill/finish and QC all as structured batch record steps with parameter capture, in-process limits and deviation workflow.
Cryo Cold-Chain Evidence
LN₂ vapor-phase and −80 °C freezer streams bound to the product record. Excursions trigger deviation with dwell-time context, not a paper chart-recorder review.
Real-time review-by-exception release
QA reviews exceptions only. Vein-to-vein time drops from weeks to days.
What changes when CGT operations have a real system.
- Apheresis-to-infusion vein-to-vein time drops meaningfully
- Viral-vector eBR review-by-exception replaces line-by-line QA review
- ISBT 128 / SEC-178 label errors stop happening
- Cryo excursions are contextualised, not investigated in days
- EMA Annex 2A and FDA Part 1271 Subpart D evidence is a report, not a project
Designed against the CGT inspector's checklist.
21 CFR Part 1271 Subpart D
cGTP for HCT/Ps — donor eligibility, processing controls, labelling, storage, distribution and record-keeping modeled natively for autologous and allogeneic products.
EMA GMP Annex 2A + Annex 1
ATMP-specific GMP for cell and gene therapies, plus Annex 1 sterile-manufacturing expectations (CCS, aseptic connections, environmental monitoring) aligned end to end.
FACT / JACIE + AABB CT Standards
Cellular-therapy standards for collection, processing and administration mapped to document control, training and evidence capture.
21 CFR Part 11
Bound e-signatures, hash-chained audit trail, RBAC. Reviewable, attributable, contemporaneous records per ALCOA+.
CGT manufacturing software, answered.
What is CGT manufacturing software?
The system of record for a cell or gene therapy manufacturer — collection scheduling, chain-of-identity and chain-of-custody enforcement, viral-vector or cell-processing eBR, ISBT 128 / SEC-178 labelling, cryo cold-chain evidence, QC integration and Part 11 audit trail. It replaces spreadsheets, MES built for small molecules and stand-alone eBR tools with one platform.
Does V5 enforce chain-of-identity for autologous products?
Patient identifiers travel with the material from apheresis through infusion. It is not a training reminder; it is an interlock.
Does V5 handle viral-vector manufacturing?
Yes. Plasmid bank management, transfection, downstream purification (TFF, chromatography, sterile filtration) and fill/finish are structured eBR steps with parameter capture, in-process limits and deviation workflow. QC results flow live from LIMS into the batch record.
How does V5 handle cryo cold-chain?
LN₂ vapor-phase and −80 °C freezer temperature streams are bound to the product record continuously.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
See V5 Ultimate CGT Manufacturing Software with your own process.
Free trial. Real CGT workflow.