SOL-03 · Solutions · Cell & Gene Therapy
Audit-ready by default — in the most scrutinised corner of pharma.
Cell and gene therapy facilities compress extraordinary complexity into small, intensely regulated spaces: closed processing, complex equipment chains, novel processes — and regulators watching more closely than anywhere else in the industry. Qualification requirements are heavy, timelines are investor-driven, and the teams are often young companies building their first commercial facility.
The struggle
What makes readiness hard here
Regulatory scrutiny without precedent
Novel modalities mean regulators probe deeper — documentation must hold up to first-principles questioning.
Complex qualification, small teams
The qualification workload of big pharma, carried by a fraction of the headcount.
First-facility risk
Many CGT companies are commissioning their first GMP facility — with no institutional CQV playbook to lean on.
Speed pressure from every direction
Patients waiting, investors watching, competitors racing — the startup date carries existential weight.
The opportunity
Where the leverage is
For a small team under maximum scrutiny, the highest-leverage move is making compliance a by-product of the work rather than a separate workload. When every executed step lands in a linked, signed, retrievable record automatically, a ten-person CQV team can produce documentation that withstands the deepest audit — without becoming a documentation factory.
With Rowsys
What changes
- Audit-ready by default
- Every record indexed and linked as it is created — evidence retrieval in seconds, every day of the project. Audit & Evidence Hub
- A playbook in the platform
- Pharmaceutical-grade templates and workflows give first-facility teams a proven framework from day one. Protocol Builder
- Compliance without headcount
- Automatic traceability and in-flow Part 11 signatures deliver control that would otherwise take a dedicated documentation team. Traceability Engine
- Deviation control under scrutiny
- Deviations raised, assessed and closed in context — with the disciplined record regulators expect in novel modalities. Deviation Management
Outcomes
What you get
- Documentation that withstands first-principles regulatory questioning
- A small team delivering big-pharma-grade control
- Startup timelines protected by live risk visibility
- Evidence ready every day — not assembled before each audit
Not sure where you stand? Take the 3-minute readiness assessment
Direct answers
Cell & Gene Therapy — common questions
We're a small team building our first facility. Is Rowsys too heavy for us?
The opposite — Rowsys replaces the administrative machinery you would otherwise have to invent. Small teams get the most leverage: the platform carries the templates, traceability and evidence management a first facility would otherwise need dedicated staff to maintain.
How does Rowsys support ATMP-specific qualification approaches?
Rowsys is configured to your qualification strategy — closed-system verification, equipment chains, environmental and utility qualification — rather than imposing a fixed model. The thread structure applies regardless of modality.
See the method in practice
See Rowsys on a cell & gene scenario.
Bring your project — the demo runs on your kind of facility, your kind of systems, your kind of audit.