Specialized computer system and process validation for cell and gene therapy — chain of identity and custody, ISBT 128 labeling, and the complex, patient-specific systems that off-the-shelf validation shops aren’t built for.
Scope
Where CGT needs specialized assurance
Autologous and allogeneic workflows put unique demands on data integrity and traceability. We validate for them specifically.
⛓
Chain of identity & custody
The patient-to-product-to-patient thread — validated so identity and custody are never in question.
▦
ISBT 128 labeling
Standardized labeling and coding for cellular products, validated end to end.
◰
Apheresis-to-infusion systems
The systems spanning collection, manufacturing and administration.
⊡
MES & batch records
Electronic batch records for patient-specific lots, with full data integrity.
◎
Cryo & logistics tracking
Temperature, location and custody tracking across the cold chain.
✓
FACT / JACIE alignment
Validation that supports accreditation and regulatory expectations.
Deliverables
What you receive
- CGT-specific validation plan
- Chain-of-identity/custody risk assessment
- Patient-specific batch record validation
- ISBT 128 labeling verification
- Data-integrity (ALCOA++) evidence for COI/COC
- Integration validation across the workflow
- Traceability matrix
- Audit-ready validation summary report
A niche we know. CGT complexity — patient-specific lots, COI/COC, ATMP expectations — is where generalist validation falls short and specialization pays off.
How it works
From collection to infusion, validated end to end
STEP 01
Map
Trace the full patient-product-patient workflow.
STEP 02
Assess
Risk-assess COI/COC and data-integrity exposure.
STEP 03
Validate
Prioritize the identity- and safety-critical systems.
STEP 04
Sustain
Maintain control across process and system change.
Why SQA Solution
Why teams choose us
Genuine CGT experience
Hands-on with COI/COC, ISBT 128 and ATMP-style workflows — not a generic template re-skinned.
Data integrity at the core
CGT lives or dies on traceability; we treat it as the priority, not an afterthought.
Accreditation-aware
Validation that supports FACT/JACIE and regulatory expectations together.
Senior, defensible work
Named consultants who can stand behind the evidence in an audit.
Fixed-fee, transparent scope
A defined engagement with a defined price and timeline — no open-ended hourly billing. Scope scales to your systems and goals.
Get a scoped quoteValidation built for cell & gene therapy complexity
Tell us about your CGT platform and workflow. We’ll scope a fixed-fee validation path.
Request a Quote
