01
A new system is going live
SAP, Veeva Vault, LIMS or MES must be validated beforehand. Delays cost production time.
Our methodologyCSV consulting · Pharma · Biotech · MedTech
CSV consulting for Pharma, Biotech & MedTech — GxP-compliant validation.
Your go-live. On time. On budget. Zero findings.
Boutique consultancy for Computer System Validation. Senior-only delivery, risk-based to GAMP 5, audit-secure from kick-off to go-live.
Your validation journey
GAMP 5 · 8 weeks to go-live
- Kickoff
- Spec
- IQ
- OQ
- PQ
- Audit-Pass
- systems validated
- 60+
- years of practice
- 17+
- audit pass rate
- 100%
- critical findings
- 0
Methodology basis
CSV consulting for Pharma, Biotech and MedTech supports companies with the computer system validation of their GxP-relevant systems from intended use to go-live. This includes the URS, risk assessment, supplier assessment, risk-based testing and approval. DHC connects the business process, IT and Quality within a clearly defined scope. Documentation and testing depth follow GxP risk; responsibilities, quality gates and handover remain transparent.
Evidenced across 17+ years: 60+ validated systems, 100% audit pass rate, 0 critical findings.
01 Foundations
What does Computer System Validation mean in Pharma & Biotech?
Computer System Validation (CSV) is the documented proof that an IT system in a GxP-regulated environment reliably and reproducibly fulfils its intended function. For Pharma, Biotech and MedTech — the regulated life sciences — CSV is not an option but a market-authorisation prerequisite. No validated state, no product sale.
The regulatory frame is clear: GAMP 5 sets the methodology standard for risk-based validation. Annex 11 governs computerised systems in the EU, while 21 CFR Part 11 defines electronic records and signatures for the FDA.
CSV differs sharply from generic IT validation. GxP requirements enforce a gapless audit trail, secured electronic signatures and data integrity per ALCOA+. These requirements decide whether a system is audit-secure — or becomes the weak point at the next FDA or EMA inspection.
dhc has validated within exactly this frame for 17+ years: 60+ systems, 100% audit-pass rate, 0 findings.
02 Trigger situations
When do you need an external CSV consultant?
In-house QA and IT teams in Pharma, Biotech and MedTech run at capacity. When timeline or audit pressure rises and the validated state starts to wobble, external support pays off.
Deep-dive · LP4
Want your compliance reviewed?
GAMP 5 audit strategy: risk-based scope, Annex 11 + 21 CFR Part 11 mapping, audit dossier — all on the dedicated landing page.
03 Our methodology
Our IVE methodology — Integrated Validation Execution.
dhc works to IVE — Integrated Validation Execution. Three pillars carry one shared roof: your go-live. On time. On budget. Zero findings.
Three pillars, three effects: a frictionless workflow, gapless regulatory security, and results from week 1.
Integrated · Cross-stream integration
No new framework — we slot into yours.
We don't bring an external framework your team would have to learn. We integrate into your existing structures and close the gaps between IT, QA and business. Stakeholder alignment, interface clarification and cross-stream coordination end the friction between departments.
The result: less friction, a relieved team, and a system that works in practice. Everyone speaks the same language.
Validation · Quality assurance
Risk-based methodology — proven over 60+ systems.
Risk-based validation per GAMP 5 (2nd Edition), ISPE Good Practice Guides and current FDA expectations (CSA). What others are discovering as the new standard has been our methodological foundation for years. OQ/IQ/PQ tests, audit-trail design and gapless documentation give you the regulatory backing your project deserves.
Compliance becomes the success factor for every audit — not a blocker. Backed by 60+ validated systems and a 100% audit-pass rate.
Execution · Delivery & project management
Plans only get you to slides — we get you to go-live.
A validation plan that's only documented but not operationally delivered won't bring you to go-live. We deliver it — and run the project steering at the same time. Validation management and project leadership sit in one responsibility. We coordinate test execution, data migration, user training and cutover as a cross-stream effort. Critical points are addressed early — before they threaten the project timeline.
You see first results from week 1, keep your budget, and reach your go-live on schedule.
04 CSA transformation
From document-heavy CSV to risk-based software assurance.
The FDA issued a revised final Computer Software Assurance guidance in February 2026. It supersedes the September 2025 version and aligns the document with the amended 21 CFR Part 820 Quality Management System Regulation (QMSR). Its direct scope remains computers and automated data processing systems used in medical-device production or quality management systems. For other Pharma GxP contexts, its risk-based methods can inform a GAMP-5-aligned CSV approach — but the FDA scope must not be extended by wording alone.
Define applicability and portfolio
Classify systems by intended use, regulatory context and process impact. Separate direct FDA CSA scope from other GxP systems that continue under their applicable CSV framework.
Build the risk model
Connect reasonably foreseeable failures to patient safety, product quality and data integrity. The risk decision determines assurance depth — not a fixed document count.
Select assurance activities and records
Use scripted or unscripted testing, supplier evidence, monitoring and other activities in proportion to risk. Keep objective evidence that makes the decisions reproducible.
Pilot, govern and scale
Prove the method on one suitable system, then update procedures, templates, reviewer competence, metrics and change controls before portfolio-wide rollout.
CSV and CSA:
CSA does not remove the obligation to demonstrate fitness for intended use. The non-binding guidance recommends how assurance effort and records are justified within its scope; binding obligations arise from the applicable regulations. The four phases above are DHC's implementation model, not a verbatim FDA checklist.
Primary source: FDA — revised final Computer Software Assurance guidance, February 2026
05 Systems & platforms
Validated systems & platforms we work with
Computer System Validation is required wherever GxP-relevant data is created or processed. dhc validates the systems that Pharma, Biotech and MedTech companies run on every day — from the ERP backbone to the cloud platform. For cloud- and SaaS-based systems this is where our Cloud System Validation comes in.
- SAP S/4HANA Validation of ERP migrations (Greenfield, Brownfield, Bluefield) including customising and interfaces.
- Veeva Vault GxP-compliant validation of the cloud modules QMS, QualityDocs and PromoMats — including release strategy for Veeva updates.
- LIMS Method validation and analytical data integrity per ALCOA+ in lab environments.
- MES (Werum PAS-X) Validation of production IT with focus on electronic batch records (eMBR) and a gapless audit trail.
- eQMS Validation of cloud-based quality management systems for change control and deviation management.
- eDMS Validated document control for controlled GxP processes and audit-proof approvals.
- Cloud-Plattformen Risk and responsibility boundary between vendor and customer — including multi-tenant and release management.
- MasterControl GxP-compliant validation of the Quality Excellence (eQMS), Document Control (eDMS) and Training modules — including validation across MasterControl releases.
06 What sets dhc apart
Boutique — not a consultant pool.
Large consultancies follow pyramid models: senior pitches the project, junior teams deliver it. In GxP-regulated projects that creates risk — when audit pressure rises, the experience that won the contract is no longer in the room.
Big consultancies
Sales and delivery sit on different teams — audit experience leaves the project after kick-off.
dhc boutique
Sales and delivery from the same senior team — audit experience present from day 1.
dhc works differently. Senior consultants sit on the project from the first workshop to go-live. No junior pool, no rotating staff, no knowledge gap between sales and delivery. You talk to the people who validate — not to the ones who last ran a validation project five years ago.
Our track record after 17+ years in regulated industry:
60+
Systems validated
17+
Years of practice
100 %
Audit-pass rate
0
Findings
Our industry focus is just as deliberate: we work exclusively for Pharma, Biotech and MedTech. No banks, no automotive, no generic IT projects. That focus isn't accidental — it's a prerequisite. GxP compliance consulting isn't something you pick up on the side.
You get senior expertise, sector-specific depth, and a proven track record. Exactly what an audit-secure validation project requires.
07 FAQ
Common questions about CSV consulting.
Timeline How long does a typical CSV validation take?
It depends on system category and scope. A clearly scoped LIMS or eQMS project per GAMP 5 typically takes three to six months. Complex S/4HANA migrations with multiple interfaces we plan in six to twelve months. Under acute timeline pressure we work in 2-week sprints and deliver first reliable results from week 1.
Pricing What does CSV consulting cost?
We work project-based or by day rate, depending on the engagement. We estimate the exact effort after a free initial analysis of your validation status. Fixed prices are possible once scope is defined.
Scope Do you also handle ongoing validation maintenance?
Yes. Periodic reviews, change-control support and re-qualifications are part of our scope — also on a retainer basis for systems we didn't originally validate.
CSA What is the difference between CSV and CSA?
CSV is the overarching demonstration that a computerised system is fit for its intended GxP use. The final FDA CSA guidance describes a risk-based assurance approach for software used in medical-device production and quality management systems: effort, test method and records follow functional risk. CSA does not remove the fitness demonstration and does not automatically apply to every Pharma GxP context.
CSA How do you transition from CSV to CSA?
First classify applicability and the system portfolio. Then connect foreseeable failures to patient safety, product quality and data integrity, select risk-appropriate assurance activities and records, and pilot the method on a suitable system. Based on the pilot, scale procedures, templates, roles, reviewer competence, metrics and change controls.
Cloud Do you work with cloud systems?
Yes. More than half of our current projects run in cloud environments — Veeva Vault, SAP RISE, ServiceNow GRC. We clarify the responsibility split between vendor and customer and secure the multi-tenant specifics.
Audit What happens if an audit is announced on short notice?
We engage within 4 to 8 weeks. We prioritise risk-based, close documentation gaps and take over your team's audit preparation.
Geography Which countries do you work in?
DACH region as our primary base, EU-wide on a project basis. English-language validation documentation for FDA audits is standard.
Let's make your project
audit-proof.
Your project deserves a validation that accelerates go-live — not blocks it. Benefit from the assurance of 60+ successful projects.
60+
Projects
17+
Years
100 %
Audit-Pass
0
Findings
Free initial assessment · Focus on your project, not slides