Automate ETQ Compliance Across the Enterprise
Structured for Regulation. Optimized for Growth.

ETQ compliance automation replaces manual compliance management – CAPA tracking, audit coordination, document distribution, supplier corrective actions, regulatory reporting – with ETQ workflow logic that initiates, routes, escalates, and closes compliance events automatically. Kernshell delivers end-to-end: programme assessment, workflow design, configuration, CSV validation, go-live, and ongoing optimisation – with accountability for audit trail integrity, regulatory defensibility, and programme performance.

CAPA, nonconformance, audit management, document control, supplier quality, complaint management, training management, change control, risk management, and equipment and calibration – individually or as an integrated compliance automation programme. Scope prioritised by your regulatory obligations, manual process burden, and inspection risk profile.

Yes – under 21 CFR Part 11, EU Annex 11, and GAMP 5, automated compliance workflows and electronic records require CSV. Kernshell designs for validation from the first configuration session: validation master plan, IQ/OQ/PQ protocol development and execution, traceability matrix, deviation management, and the complete inspection-ready documentation package. Validation is not an afterthought.

A focused single-module automation – CAPA or document control – reaches production in 8–14 weeks including CSV. Multi-module programmes are scoped with clear milestones following the compliance assessment – typically 16–28 weeks depending on module count, workflow complexity, integration scope, and validation requirements.

Every automated workflow is designed with end-to-end audit trail mapping – every status change, approval, signature, escalation, and exception logged in ETQ with timestamp, user identity, and action context. Electronic record and signature integrity verified during OQ execution. Post-deployment, audit trail continuity monitoring detects gaps before they become inspection findings.

Yes site-specific workflow variants, jurisdiction-specific regulatory obligation mapping, language localisation, and consolidated global compliance KPI reporting – all within a single governed ETQ platform. Global compliance visibility without requiring uniform workflow standardisation across every site.

Yes – ongoing managed services covering workflow monitoring, compliance KPI reporting, regulatory change impact assessment, workflow optimisation as processes evolve, periodic validation review, and ETQ platform update management. Compliance automation requires active governance as obligations change and organisations grow — not a support desk responding to break-fix tickets.