Products That Own The Workflow
Two AI-native platforms — one for validation, one for clinical documentation. Both purpose-built for regulated Life Sciences.
- FDA
- EMA
- MHRA
- PMDA
- CDSCO
- GAMP 5
- ICH Q9
- 21 CFR Part 11
Cybroscape builds two AI products for regulated life sciences. GxP Copilot produces the validation or qualification package for a system, instrument or piece of equipment. TraceDraft produces clinical documents — study reports, protocols, safety narratives, clinical evaluation reports — with every statement traceable to its source. Both draft; qualified people decide and sign.
GxP Copilot compresses computer system validation from months to weeks — for pharma, biotech, medical device, CRO and diagnostics teams that need to ship compliant systems quickly, without adding QA headcount or absorbing a year-long incumbent rollout. A short intake produces a complete, GAMP 5 Second Edition-aligned validation package, sized to real per-requirement risk under FDA's Computer Software Assurance guidance. Your validation leads review, refine and sign; the platform handles the drafting, traceability and evidence assembly. Every action is captured in a tamper-evident audit trail with real 21 CFR Part 11 electronic signatures — so you are inspection-ready the day you go live.
TraceDraft accelerates clinical and regulatory writing for CROs, biotech, med-device and pharma teams — Clinical Study Reports, protocols and amendments, Investigator Brochures, DSURs, IND annual reports, HAQ responses, IND packages, safety narratives and Clinical Evaluation Reports. Every generated sentence links back to the source data that produced it, so sponsors, auditors and regulators can walk any claim back to its origin. A dedicated review queue keeps human medical writers in the loop; a tamper-evident audit trail keeps the compliance evidence ready. Writers stop assembling and start deciding — throughput goes up, quality holds, and AI use becomes something you can actually defend to a sponsor.
Which one you need depends on your bottleneck
These solve different problems for different buyers. If the thing holding you up is getting systems validated and keeping them that way — a LIMS going live, an inspection finding, a vendor upgrade that broke validated status, an estate inherited through acquisition — that is GxP Copilot.
If the constraint is clinical writing capacity — CSR turnaround limited by writer headcount, a narrative queue that appears after database lock, a CER that has aged past what a notified body will accept — that is TraceDraft. Neither requires the other, and most organisations start with one.
What they share, and why it matters
Both are built on the same position: AI drafts, qualified humans decide and sign. Classification, risk and release verdicts are computed from confirmed facts rather than generated, so the same inputs always give the same answer and an inspector gets a derivation rather than a model output.
Both enforce the same record discipline — re-authentication at signing, the meaning of the signature recorded, signed versions frozen, author separated from approver, and a tamper-evident audit trail. The practical consequence is that a quality team which has assessed one product has already covered most of the ground for the other.
Where the AI is deliberately not allowed
The most important design decision in both products is where the model does not operate. Risk scores, GAMP categories, USP <1058> groups, traceability coverage and release verdicts are computed in code from stated rules. "The model assessed it" is not an answer an inspector accepts, and no amount of model quality makes it one.
That line is also what the draft EU Annex 22 expects: a qualified person remains accountable for any decision affecting product quality or patient safety. It is not a constraint we work around — it is the condition under which AI belongs in these workflows at all.
Product and delivery, not one or the other
Software alone rarely solves a validation or documentation backlog, because the constraint is usually a mix of tooling, procedure and available expertise. Our services practice runs the same work as an engagement, with or without the products, so you are not forced to adopt a platform to get a package delivered.
Common questions
What is the difference between GxP Copilot and TraceDraft?
GxP Copilot validates systems: it produces the computer system validation or equipment qualification package for a LIMS, an instrument, a piece of equipment or a SaaS application. TraceDraft writes clinical documents: study reports, protocols, safety narratives and clinical evaluation reports. Different buyers, different deliverables, the same underlying discipline about provenance and human approval.
Which one do we need?
If your bottleneck is getting systems validated and keeping them validated, that is GxP Copilot. If it is clinical writing capacity — CSR turnaround, narrative volume, CER updates — that is TraceDraft. Organisations that run both typically arrive at one first and adopt the second once the compliance posture has been tested in practice.
Do the products require each other?
No. Each is used independently and most customers use one. They share the same approach to electronic records, signatures and audit trail, which means a quality team that has assessed one has already covered most of the ground for the other.
Can we use our own AI model?
The AI provider is swappable rather than fixed. This matters in regulated environments where a model change is a change to a validated system — you need to know whose model you are running, to pin it, and to be told before it changes.
What do both products refuse to do?
Neither lets AI make a GxP-critical decision. Classification, risk scoring and release verdicts are computed from confirmed facts rather than generated, and approval is always a re-authenticated electronic signature by an accountable person. AI drafts, retrieves and proposes; a qualified human decides and signs.
See it on your own data. In 30 minutes.
Bring a system, a URS, or an AE listing. We'll show you how GxP Copilot and TraceDraft compress the validation and clinical documentation cycle without compromising Part 11 or Annex 22 posture.