Ready for the inspector on an ordinary day.
Plan internal and supplier audits, manage findings, prepare for inspections with a regulation crosswalk, and run management review and APQR from live data.
Audit and inspection readiness in Cybroscape eQMS plans internal and supplier audits, links findings to CAPA, maps your records against the regulations an inspector will use, and builds management review and annual product quality review reports from live quality data rather than from spreadsheets assembled the week before.
Inspection preparation as a project
Many sites prepare for an inspection as a separate project: weeks of collecting records, chasing overdue actions and reconciling numbers. That effort is a sign the records were not ready on an ordinary day.
A crosswalk to the regulations
Records are mapped to the clauses of the regulations and standards that apply to you, so you can see the evidence for a clause and where it is thin, before an inspector asks.
Reviews built from live data
Management review and APQR pull deviations, CAPA, complaints, changes and supplier performance directly from the records. Quality Copilot drafts the narrative; the quality head reviews and signs it.
What you get
What Audits and Inspection Readiness delivers
Audits and Inspection Readiness is part of the Cybroscape eQMS platform — an AI-native, agentic quality management system built for regulated Life Sciences. See how it fits with Document Control, Deviations and Investigations, CAPA Management.
- Internal and supplier audit programmes
- Findings linked to CAPA
- Regulation crosswalk for inspection preparation
- Management review and APQR from live records
Common questions
Prefer to talk first? Chat with us on WhatsApp or book a call with an expert.
Which regulations are in the crosswalk?
The GMP and quality regulations most teams work under, including 21 CFR Parts 11, 210/211 and 820, EU GMP including Annex 11, ICH Q9 and Q10, and ISO 13485 and 14971 for devices.
Related capabilities
All capabilitiesWrite, review, approve and make effective SOPs, work instructions and forms, with periodic review dates and revisions opened automatically by the change that requires them.
Learn more about Document ControlDeviations and InvestigationsCapture deviations at the point they happen, classify severity, run the investigation with structured root-cause tools, and close only when the evidence supports it.
Learn more about Deviations and InvestigationsCAPA ManagementPlan corrective and preventive actions from the investigation, assign owners and dates, check effectiveness, and let the CAPA raise the change and the SOP revision it needs.
Learn more about CAPA ManagementChange ControlAssess, approve and implement changes with a risk-based impact assessment. Approved changes state their validation impact and pass it to GxP Copilot.
Learn more about Change ControlTraining and QualificationRole-based training matrices, assignments triggered by document changes, and a qualification check that stops someone with lapsed training from signing for GMP work.
Learn more about Training and QualificationSupplier QualityQualify suppliers, hold quality agreements and certificates, schedule audits, track supplier performance and let suppliers respond through a portal.
Learn more about Supplier QualitySources
Primary documents referred to on this page, from their official publishers.
See audits and inspection readiness on your own data.
Bring a recent deviation or change. We show you how it runs end to end, from intake to closure.
- We reply within one business day
- We walk through your own records
- You get a clear migration plan