CSV / CSA
Risk-based validation and assurance for GxP computerised systems.
Life-sciences organisations now run a complex mix of on-premise, SaaS and cloud-hosted systems across laboratories, manufacturing, quality, pharmacovigilance and clinical operations. Regulators expect these systems to be validated and kept in a controlled state throughout their lifecycle – but traditional, document-heavy Computerised System Validation (CSV) makes this slow and expensive.
Amalia’s GxP software validation service combines modern CSV and Computer Software Assurance (CSA) approaches. We use GAMP 5 Second Edition, FDA CSA guidance and ICH Q9 quality-risk principles to focus effort where it matters most: patient safety, product quality and data integrity.
We bring structured methods, ready-to-use templates and hands-on validation experts so you can move faster while remaining fully inspection-ready.
Why GxP Software Validation (CSV & CSA) Matters
Regulators such as FDA and EMA require that GxP-relevant computerised systems are validated for their intended use and operated in a state of control.
Inspection-ready validation packages
Complete, well structured documentation with strong requirements and full traceability between risks, tests and results
Efficient delivery of systems and changes
Testing effort is proportionate to risk, ensuring critical functionality receives the right level of scrutiny without slowing delivery
Standardised approaches across sites and vendors
A unified CSV/CSA methodology that reduces confusion, duplication and rework
Controlled lifecycle management
Consistent processes for change control, periodic review, decommissioning and data retention
What We Do Under GxP Software Validation (CSV & CSA)
We provide end-to-end CSV & CSA support, from initial risk assessment through go-live and ongoing lifecycle management. Our approach is built on your CSV&A Standard Service Procedure and aligned with GAMP 5 Second Edition and FDA CSA guidance.
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The GxP processes your system supports (using Business Process Specifications where helpful)
Where it sits in your manufacturing, lab, clinical or quality landscape
Applicable regulations and guidances (for example, 21 CFR Part 11, EU GMP Annex 11/15, GAMP 5, data-integrity expectations)
Current validation status, documentation and known gaps
We usually formalise this in an Initial Assessment (IA), covering GxP relevance, system complexity, infrastructure, ERES and migration considerations.
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System description and architecture / Roles, responsibilities and deliverables
Scope and boundaries (GxP vs non-GxP functionality)
Validation / assurance approach aligned with GAMP 5 and FDA CSA guidance
Use of vendor documentation and testing, test strategy, deviation management
We also clarify prerequisites such as infrastructure qualification, supplier assessments, and change/deviation SOPs.
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User Requirement Specifications (URS) – Business, regulatory and technical needs grouped by area (security, functional, reporting, interfaces, data, audit trail)
Technical / functional / design / configuration specifications (TS/FS/DS/CS) – Translating URS into implementable system behaviour, using vendor artefacts where appropriate.
Exploring options for automation, integration and self-service where relevant
This gives a clear link from requirements to risk, which then drives testing and documentation effort.
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Development of Test Plans (TP) describing test strategy, scope and scripting approach
Definition of installation verification (IQ elements), functional and regression tests (OQ/PQ concepts) appropriate to system risk
Use of scripted testing for high-risk functionality with step-by-step instructions and expected results
Use of unscripted or exploratory testing for lower-risk functions, as advocated by CSA, with concise evidence of coverage
Where vendors already provide robust, documented testing, we leverage it instead of duplicating effort, in line with modern risk-based guidance.
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Deviation Management Documents (DMD) capturing all deviations, impact, corrective actions and status; ensuring no system goes live with unresolved critical issues.
Traceability Matrices (TM) linking requirements, specifications, risks, tests and results so reviewers can see exactly what was tested and why.
Confirmation that validation activities support data-integrity requirements across the full data lifecycle (create, process, store, share, archive, destroy).
All activities are summarised in a Validation Report (VR) that concludes on fitness for use, release to production, hypercare and maintenance of validation status.
Deliverables
Typical deliverables from a GxP software validation (CSV & CSA) engagement include:
Visualisation of GxP-relevant processes across one or more systems.
Structured questionnaire assessing GxP relevance, complexity, infrastructure, ERES and migration needs.
System description, architecture, strategy (CSV / CSA), scope, roles, deliverables, test strategy, deviation management and acceptance criteria.
SMART, testable requirements grouped by category.
System-specific specifications, using supplier artefacts where appropriate.
FMEA or CSA-based assessment of requirements, driving mitigation and testing effort.
Scripted and unscripted tests with supporting evidence and Test Reports.
Central record of deviations, impact, criticality and closure status.
End-to-end traceability from requirements and risks to tests and outcomes.
Summarising activities, results, deviations, acceptance against criteria and release to production, including hypercare and maintenance of validation status.
Where useful, we can also help you tailor or create SOPs and work instructions to embed CSV/CSA practices across your organisation.
Customer Stories & Insights
Outcomes You Can Expect
Clear, risk-based documentation aligned with EU GMP Annex 11/15, 21 CFR Part 11 and GAMP 5 Second Edition.
CSA-informed critical thinking that reduces unnecessary testing and paperwork while strengthening focus on high-risk functionality.
Validation activities designed around data-lifecycle risks, not just system features.
Validation integrated with cutover and handover planning, reducing late surprises and production risk.
A process library that can be used for training, onboarding, audits, automation and continuous improvement.
When to Consider GxP Software Validation (CSV & CSA)
Your are implementing new GxP-relevant systems (LIMS, MES, QMS, EDC, ERP, serialisation, data platforms, SaaS solutions)
You are upgrading, re-platforming or migrating existing validated systems (for example, on-premise to cloud, instance mergers)
You are introducing or revising your corporate CSV/CSA methodology and templates
You are responding to inspection findings or audit observations related to computerised systems, data integrity or documentation gaps
You are performing retrospective validation of legacy systems that have outgrown their original documentation
You are seeking to adopt CSA, GAMP 5 Second Edition and critical-thinking approaches without adding risk
Why Amalia
We help organisations turn complex change into solutions that people actually use. We combine structure, respect and creativity so your teams deliver better outcomes with less friction. Here is what that looks like in real engagements.
We remove what isn’t needed while keeping essential controls and compliance. The result is clear, practical systems that are easy to adopt and maintain.
A single, senior, cross-functional team replaces multiple vendors. Fewer hand-offs, faster delivery, and one accountable partner throughout.
We align leadership, QA, IT and operations around shared decisions. Clear reasoning, documented outcomes, and no misalignment.
Solutions are built around real processes and real risk. Practical delivery that avoids shelfware and drives measurable outcomes.
We bring global experience and adapt it to your specific context and operating reality. Proven frameworks, applied flexibly where they matter most.
Senior leaders stay involved from start to finish on every engagement. Each programme is treated as a long-term partnership, not a one-off project.
Want to simplify complex work without losing control?
Work with a team that can join up governance, assurance, platforms and technical depth from start to finish.