What Software Validation GmbH does

Software Validation GmbH is a privately held Swiss consulting firm (GmbH) headquartered in Allschwil, Basel-Landschaft, founded and led by Thomas Müller, who is also chair and co-founder of ISTQB (International Software Testing Qualification Board) and chair of the Swiss Testing Board. The firm delivers professional services across six interrelated modules — Software Validation, Risk Management, Software Testing, Business Analyses (requirements engineering), Compliance Management, and Auditing — anchored in industry-standard frameworks including GAMP 5, IEEE (including IEEE 1012), ISO software standards, ISTQB, and IREB, rather than proprietary software products. Its methodology stack includes a four-layer Requirements Abstraction Model (System/Strategy, Feature, Function, Implementation) and a GAMP 5-aligned five-step risk process.

The firm operates a consulting-led, relationship-driven GTM focused on regulated industries where software validation is mandatory: pharmaceuticals and medical devices (primary vertical), chemical, banking, power plants, traffic engineering, clinical research, and lab/chromatography systems. Engagements are sold as project-based calendar-day or person-day mandates (e.g., a 25 calendar-day eTMF validation engagement, a 20 person-day agile transformation mandate), supplemented by a fixed-price training program (Computerized Systems Validation, Test Management, Methodical Testing) priced at CHF 6,000 per 2-day standard module and delivered as in-house corporate workshops or public seminars. The team comprises six named professionals, including five senior consultants plus one back-office employee, supported by the founder's authoritative standing in international software testing certification.

The business is a classic boutique expert consultancy — no packaged software product, no recurring SaaS or licensing revenue, no external funding, and no disclosed financial information. Marketing is content- and community-led, anchored by the firm's corporate website (validation.ch) and the founder's leadership of ISTQB/Swiss Testing Board rather than paid channels. Revenue is generated almost entirely from time-and-materials consulting and fixed-price training engagements, which makes top-line highly dependent on utilization and on the senior practitioners' personal client relationships.

Name

Software Validation GmbH

Legal name

Software Validation GmbH

Website

https://validation.ch

Company type

Private

Operating status

Operating

Headcount range

1–10 employees

Short description

Software Validation GmbH is a Swiss boutique consultancy that delivers software validation, risk management, testing, compliance, and auditing services — plus ISTQB/IREB-aligned training — to regulated industries, primarily pharma and medical devices, using GAMP 5 and IEEE frameworks.

Ownership category

akta.pro rank

Product category

Regulated Software Validation & GxP Compliance Consulting

NAICS

Testing Laboratories and Services (541380), Custom Computer Programming Services (541511), Software Publishers (513210)

SIC

Services-Computer Programming Services (7371), Services-Testing Laboratories (8734)

akta.pro primary industry

Computer System Validation (CSV) & GxP IT Compliance (21 CFR Part 11/Annex 11) (HLAGAKAG)

Keywords

• Software validation consulting
• Computerized systems validation
• GxP compliance auditing
• Software testing services
• Risk management consulting

Headquarters

HQ city

Allschwil

HQ country

Switzerland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Others

Revenue model

1. Training Services: Fixed-price 2-day standard training modules (Computerized Systems Validation, Test Management, Methodical Testing) priced at CHF 6,000 per module, delivered in-house at client or as public seminars. Customized agendas and exercises available.
2. Validation and Testing Consulting Engagements: Project-based professional services billed on a calendar-day or person-day basis (e.g., 25 calendar-day eTMF validation engagement; 20 person-day agile transformation mandate). Services include validation and test planning, risk analysis, release planning, audit, and DevOps enablement.
3. Auditing and Certification Services: System audits and software certifications against standards such as IEEE 1012, 21CFR820, GAMP, plus GxP audits, supplier assessments, internal and mock audits, and TPI/CMMI maturity assessments.

Pricing tiers

Go-to-market motion3 records

Distribution channels3 records

Marketing channels4 records

Core offering

Software Validation GmbH delivers professional consulting services that verify, validate, and test regulated computerized systems for enterprise clients in pharmaceutical, medical device, chemical, banking, power-plant, traffic, and clinical research industries. Engagements cover software validation, GAMP 5-aligned risk management, software testing, requirements engineering, compliance management, and auditing, and are complemented by standardized 2-day training courses (Computerized Systems Validation, Test Management, Methodical Testing). Services are sold and delivered directly to client sites on a project or training basis against regulatory standards such as 21 CFR Part 11, EU GMP Annex 11, GAMP 5, IEEE, ISO, ISTQB, and IREB.

Product overview

Software Validation GmbH is a Swiss professional-services / consulting firm — not a packaged software vendor — that delivers a portfolio of six interrelated service modules: Software Validation, Risk Management, Software Testing, Business Analyses, Compliance Management, and Auditing, complemented by a Training program comprising three standard courses (Computerized Systems Validation, Test Management, and Methodical Testing). The service modules fit together as a risk-based, GAMP 5-aligned life cycle: Business Analyses defines and traces requirements, Risk Management drives prioritization, Software Testing executes and reports, Software Validation packages the evidence into a validation report, Compliance Management ensures regulatory alignment, and Auditing independently verifies the result. Training reinforces each module with ISTQB/IREB-aligned courses.

Differentiator

Problem solved

Functional benefit

Products and services

• Software Validation End-to-end computerized systems validation service producing a validation plan, risk analysis, test plan, test reports, and a final validation report, aligned with regulatory requirements (e.g., 21 CFR Part 11, EU GMP Annex 11) and the client's business, project, and development standards.
• Risk Management Risk-based control of development and test processes following the GAMP 5 five-step approach: define initial risk, identify harmful characteristics/functions, perform detailed function-level risk analysis with countermeasures, monitor countermeasure effects, and assess/document residual risk before release.
• Software Testing Software testing service that identifies defects early in procurement, development, and implementation, covering test analysis and design, exploratory testing, test implementation and execution (including installation qualification), exit-criteria evaluation and reporting, and test-activity closure with lessons learned.
• Business Analyses Requirements engineering service that structures requirements across four abstraction layers (System & Strategy, Feature, Function, Implementation) to deliver measurable, verifiable, traceable requirements aligned with regulatory, functional, and quality requirements.
• Compliance Management Pragmatic compliance service that implements regulatory requirements (FDA, GxP, MPG), qualifies and validates processes, equipment, and computerized systems, and aligns work with GAMP 5, IEEE, ISO standards, and the ISTQB/IREB certification schemes.
• Auditing Process, system, and software auditing service running GxP audits, supplier assessments, internal and mock audits, maturity assessments against models such as TPI and CMMI, and software certification against standards such as GAMP and IEEE 1012.
• Training Program Public and in-house training program delivered by certified trainers, comprising three standard 2-day modules (Computerized Systems Validation at CHF 6,000, Test Management at CHF 6,000, and Methodical Testing at CHF 6,000 for 2 days), all customizable to the client's system context, with alternative formats including 2-3 hour classroom training plus self-study and a Mastery Learning Program in English.

Quantifiable outcome

• 50+ quality audits performed worldwide by team member Andrzej Sudenis (individual contribution prior to/within the firm)
• +2 more outcomes

Segments7 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Eleven partnerships are on record, tiered minor, flagship and core.

• JKweb – Webdesign Basel & ZürichminorOthersJKweb designed and built the company's corporate website (concept, design, programming) and is credited on the Impressum/Legal pages as the web design partner.
• ISTQB (International Software Testing Qualification Board)flagshipStrategic or Co-development PartnerOwner/CEO Thomas Müller is chair and co-founder of ISTQB, helping shape the international foundation-level test training syllabus. ISTQB is the certification body whose credentials the firm teaches and applies (Certified Tester Foundation, Advanced, Agile Tester).
• Swiss Testing BoardflagshipStrategic or Co-development PartnerOwner/CEO Thomas Müller is chair of the Swiss Testing Board (software-tester.ch), the national ISTQB member body for Switzerland, aligning the firm with the local certification ecosystem.
• ISPE (International Society for Pharmaceutical Engineering) — GAMPcoreStrategic or Co-development PartnerISPE's GAMP 5 ('A Risk-Based Approach to Compliant GxP Computerized Systems') is a primary methodology that the firm applies, teaches, and uses as the basis of its Computerized Systems Validation training; the firm references ISPE in its Regulation repository.
• IREB (International Requirements Engineering Board)coreStrategic or Co-development PartnerIREB's Certified Professional for Requirements Engineering framework is used for requirements engineering certification; team members (Thomas Müller, Stefanie Lokai) hold IREB Foundation Level certification, and the firm teaches IREB-aligned methods.
• IEEE (Institute of Electrical and Electronics Engineers)coreStrategic or Co-development PartnerIEEE software standards (e.g., IEEE 1012 for software verification and validation, IEEE 610.12) form the basis of the firm's standards alignment in compliance management, auditing, and certification services.
• ISO (International Organization for Standardization)coreStrategic or Co-development PartnerISO software standards are referenced in the firm's Regulation repository and applied alongside GAMP 5 and IEEE for compliance management and auditing.
• FDA (U.S. Food and Drug Administration)coreStrategic or Co-development PartnerFDA regulations (21CFR Part 11, GMP, GLP, QSR, Electronic Records) are core to the firm's GxP audit, validation, and compliance management services.
• SwissmedicminorStrategic or Co-development PartnerSwissmedic regulatory texts are referenced in the firm's Regulation repository as part of its compliance and audit services in Switzerland.
• PIC/S (Pharmaceutical Inspection Co-operation Scheme)minorStrategic or Co-development PartnerPIC/S guidance is referenced in the firm's Regulation repository and informs its GxP audit and validation services.
• ICH (International Conference on Harmonisation)minorStrategic or Co-development PartnerICH technical requirements for registration of pharmaceuticals for human use are referenced in the firm's Regulation repository and applied in computerized systems validation engagements.

Scale indicators7 records

Direct peers

• Maetrics: Life sciences compliance and computerized systems validation consultancy serving pharma, biotech, and medical device companies across the US and Europe. Direct peer: same core GxP/CSV consulting offering, similar boutique positioning, and overlap on regulated industries.
• KVALITO AG: Swiss life sciences consulting firm headquartered near Basel offering computerized systems validation, GxP compliance, and quality management services to pharma and medical device companies. Direct peer: same Swiss base, same CSV/GxP value proposition, same regulated customer base.
• Concept Heidelberg: German organizer of training courses, conferences, and consulting services for the pharmaceutical and chemical industries, with strong overlap on GxP, validation, and regulatory training. Direct peer on the training and consulting side and on the regulated customer base.
• Arcondis: Swiss-based consulting firm serving medical devices, pharma, and diagnostics with quality, regulatory, and software validation services. Direct peer: shared Swiss base, overlapping medical-device and pharma customers, and similar focus on GxP-compliant software validation.

Broad incumbents

• NNIT (now part of Cognizant): IT services provider with a dedicated life sciences practice offering GxP validation, clinical systems, and regulated IT outsourcing to pharma. Comparable on CSV and GxP services to pharma customers, but at materially larger scale and broader portfolio.
• Pharmaplan: International engineering and qualification consultancy serving pharma and biotech with facility, equipment, and computerized systems qualification. Comparable on qualification/validation for regulated production, but broader in scope and headcount.
• BioPharma Systems (Cognizant): Cognizant's life sciences software business unit, focused on Siebel/CTMS and clinical systems validation for pharma and biotech. Overlaps with Software Validation GmbH on clinical development and lab systems validation but operates at much larger scale.
• Zifo RnD Solutions: Global scientific informatics and lab-to-commercial IT services provider with a strong life sciences practice spanning validation, GxP compliance, and lab informatics. Comparable on regulated validation work but broader in scope and significantly larger.

Emerging players

• SEIDOR: Global SAP/ERP services and solutions provider with life sciences and regulated-industry consulting including ERP/SAP validation work. Comparable on the SAP/ERP validation use case highlighted in Software Validation GmbH's offering, though primarily a technology implementation firm.
• Integris Consulting: Boutique life sciences regulatory and quality consulting firm offering CSV, validation, and compliance services to pharma, biotech, and medical device clients. Closely comparable boutique positioning, though US-headquartered.

Market position

Strengths5 records

Weaknesses5 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/software-validation-gmbh

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Software Validation GmbH