Cell and gene therapy manufacturing software with chain-of-identity and chain-of-custody as hard gates.
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.
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-identity as a hard gate
Patient identifiers (autologous) or donor identifiers (allogeneic) bound to the collection, every intermediate, every fill and every infusion event. Mismatch = physical block, not a warning.
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. Nothing moves without an attributable signature.
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.
ISBT 128 + SEC-178 in-record
MPHO product codes, DIN and cellular-therapy labels per ICCBBA generated in-record and printed via validated printers. No retype, no reconciliation.
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
Batch record locks the moment the last step signs. QA reviews exceptions only. Vein-to-vein time drops from weeks to days.
What changes when CGT operations have a real system.
- COI mismatches become physically impossible, not procedurally discouraged
- 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 in seconds, 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?
Yes — as a hard gate. Patient identifiers travel with the material from apheresis through infusion. A mismatch at any handoff — receipt at manufacturing, in-process split, cryo, ship, thaw at infusion site — physically blocks the next step. 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.
Does V5 generate ISBT 128 / SEC-178 labels?
Yes — MPHO product codes, DIN and cellular-therapy labelling per ICCBBA generated in-record and printed via validated printers. Codes are never retyped from another system.
How does V5 handle cryo cold-chain?
LN₂ vapor-phase and −80 °C freezer temperature streams are bound to the product record continuously. Excursions open a deviation with dwell-time context automatically — no paper chart-recorder review at month-end.
How long does implementation take?
Most CGT sites run their first signed viral-vector or cellular-product batch record within 45–60 days. Full multi-site autologous rollouts (apheresis sites, manufacturing, infusion centres) typically take 4–6 months depending on integration complexity.
Make chain-of-identity a hard gate, not a hope.
Free trial. Real CGT workflow. No sales gate.