GxP Copilot at a Series-B biotech — full validation package for a LIMS deployment in 4 weeks

Pain points before the engagement

• No dedicated QA or validation function — the CTO owned compliance on top of engineering
• The incumbent validation-suite quote was six figures and eight months — neither timeline nor budget was survivable
• Investors and prospective pharma partners expected inspection posture at go-live, not eventually
• The internal team had never authored a Validation Plan and had no template library
• The go-live date could not move — the discovery workflow was blocked on the LIMS

Problem

The biotech had reached the point where its discovery workflow needed a real LIMS. Their prospective pharma partners had made GxP posture a due-diligence question, not a nice-to-have. The incumbent validation platforms quoted timelines and prices sized for organisations with a validation function. Cybroscape's brief was simple: full validation package, Part 11 posture, before the go-live date — and defensible enough that a pharma partner audit would clear it.

Approach

GxP Copilot with a Cybroscape delivery lead paired with the CTO one hour a day for the first two weeks, then two hours a week thereafter. A guided intake produced the risk classification and deliverable set. Draft deliverables were reviewed against the biotech's actual LIMS configuration; scripted testing was reserved for the requirements that actually carried risk. The traceability view was live from day one, so reviewers could always see coverage without a spreadsheet round trip.