Validation of Computerized Systems
- GxP and IT Expertise from a Single Source
- 30+ Years of Experience in Regulated Industries
- SAP Silver Partner
Software Validation of GxP-relevant Systems
Digital systems are today a central part of regulated business processes – from research and development through production to quality control and approval. Accordingly, the requirements for their reliability, data integrity and regulatory compliance are high.
For management, QA and IT leadership, three questions are central:
- How can compliance risks in complex IT landscapes be managed?
- How can validation be organized economically and scalably?
- How does the company remain permanently audit-ready even with cloud platforms, frequent releases and digital transformation?
DHC supports companies in organizing software validation economically, scalably and permanently GxP-compliant.
Challenges in Software Validation
High Regulatory Requirements
GAMP 5, FDA, EU GMP, ISO standards and data integrity guidelines must be consistently implemented across many systems.
Continuous Validation in the Lifecycle
Implementations, updates, releases and changes require continuous validation activities
Audit Pressure, ALCOA+ & Data Integrity
Inspections increasingly focus on audit trails, ALCOA+, data governance and effective risk assessment.
Risk-based Software Validation According to GAMP 5
In the regulated life sciences environment, IT systems that influence product quality, patient safety or data integrity must be validated according to national and international regulations and operated in a valid state throughout their entire lifecycle. Key regulations include EU GMP, national pharmaceutical laws, DIN EN ISO 13485 and FDA requirements such as 21 CFR Part 11 and EU GMP Annex 11. Software validation is typically performed according to the industry standard GAMP®5.
DHC has more than 30 years of experience in validating complex computerized systems at SMEs and international corporations.
On this basis, we have developed a cost-efficient, risk-based and scalable methodology for computer system validation over the years.
The DHC Best Practice methodology is an IT Compliance Framework consisting of a process model, SOPs, templates, training materials and tools. It covers the entire system lifecycle – from initial implementation through operations to decommissioning and data archiving. We continuously expand our methodology with solutions for new regulatory and technological challenges (e.g. Machine Learning or Artificial Intelligence).
Learn more about Software Validation?
Digitalization of Validation: DHC Smart Validation Accelerator
To accelerate and digitalize validation processes, DHC developed the DHC Smart Validation Accelerator, a modern validation platform that significantly increases the efficiency of validation processes through the use of Artificial Intelligence (AI) and full integration into the SAP ecosystem with SAP Cloud ALM and Tricentis.
DHC Consulting Services
Compliance Check & Strategy
We create transparency about your validation and compliance structures and develop a sustainable CSV strategy.
Typical services:
- CSV framework assessments
- Fit-gap and inspection readiness analyses
- 21 CFR Part 11 & EU GMP Annex 11 assessments
- Data integrity assessments
- Development or optimization of your validation framework
- Remediation strategies
- Workshops and coaching for QA and validation managers
Computer System Validation
We handle the operational execution of validation:
- Prospective validation of new systems
- Retrospective validation of productive systems
- IT infrastructure qualification
- Risk-based test planning and execution
- Creation of key validation documents (URS, VMP, VP, VR etc.)
- Data migration and verification strategies
- Supplier qualification and supplier audits
- Audit readiness programs
Managed Validation Services
With our Managed Validation Services, we take over continuous validation tasks, ensure auditability and reduce internal resource burden.
We support for example with:
- Change management
- Release management
- Periodic reviews
- Lifecycle documentation
- Audit trail reviews
- Data integrity monitoring
Typical Systems in CSV Validation
DHC supports the validation of numerous GxP-relevant systems, including:
- ERP systems (e.g. SAP, Microsoft Dynamics 365, Oracle)
- Cloud & SaaS systems (IaaS, PaaS, SaaS)
- MES systems (e.g. SAP Digital Manufacturing, Opcenter)
- IT service management systems (e.g. ServiceNow)
- Document management systems (DMS)
- Lab IT systems such as LIMS and chromatography data systems (CDS)
- IT systems for clinical development and pharmacovigilance
- QMS / eQMS systems (TrackWise, Veeva QMS)
- Data & analytics platforms (e.g. BI/reporting systems with GxP relevance)
- Custom developments and critical spreadsheets (e.g. Microsoft Excel-based applications)
The systems listed represent only a selection of our validation expertise.
If your solution to be validated is not listed, please contact us.
Why DHC – Your Specialist for Software Validation (CSV)
For over 30 years, DHC has been supporting companies in regulated industries in validating complex IT and ERP systems, combining IT architecture, business processes and regulatory compliance in an integrated approach.
With our field-proven DHC Best Practice methodology for computer system validation and the DHC Smart Validation Accelerator, we accelerate and digitalize validation processes across the entire system lifecycle.
The DHC Smart Validation Accelerator is also part of the SAP initiative for developing an End-to-End Digital Validation Platform and supports companies in sustainably ensuring compliance, efficiency and auditability.
Computer System Validation (CSV)
Trust through Experience
We are the specialist for GxP Compliance.
“DHC developed a tailored validation concept together with us, which was then successfully implemented and audited. The collaboration so far has been outstanding, and we would gladly rely on the expertise of DHC’s experts for future projects.”
“The collaboration with DHC was always goal-oriented and very pleasant. Thanks to the high expertise in GMP and CSV as well as the development of a suitable risk management and framework, Hamilton Bonaduz AG was able to become the first Swiss life science company to achieve successful validation completion for Microsoft Dynamics D365FO in Switzerland.”
Frequently Asked Questions about Validation of Computerized Systems
Why is risk-based software validation strategically important?
Risk-based software validation according to GAMP 5 enables companies to focus validation activities specifically on critical functions and processes. This allows unnecessary testing effort to be reduced, resources to be used efficiently and regulatory requirements to be safely met at the same time. For management, this means: higher audit security with simultaneously lower costs.
Is classic computer system validation (CSV) still relevant in times of cloud, AI and agile development?
The classic principles of computer system validation remain valid – especially the risk-based approach according to GAMP 5. However, the practical implementation of validation is changing significantly.
Modern IT landscapes are characterized by cloud platforms, frequent release cycles, agile development models and increasingly AI-based applications. This shifts the focus of validation from one-time project activities to continuous lifecycle validation.
Companies must therefore integrate validation more strongly into their IT governance, change and release processes, and data integrity controls. At the same time, standardized validation frameworks, digital validation platforms and automated documentation processes are gaining importance.
Software validation is thus evolving from a pure documentation obligation to a strategic management instrument for compliance and digital transformation.
How do cloud and SaaS platforms change software validation?
Cloud and SaaS systems increase innovation speed but change the responsibilities between provider and user. Companies must align their validation strategy more strongly with governance, supplier management, release management and data integrity. Modern CSV concepts therefore consider shared responsibility models and continuous validation approaches.
How can frequent release cycles be reconciled with regulatory compliance?
Digital platforms, cloud services and agile development models lead to significantly more frequent system updates. Traditional project-based validation is no longer sufficient. Successful companies therefore integrate validation into change and release processes, use risk-based test strategies and standardized validation frameworks to ensure compliance efficiently.
How can software validation be organized more cost-effectively and scalably?
Many organizations still work with manual and project-driven validation processes. Modern approaches rely on standardized validation frameworks, digital platforms and automated documentation processes. This allows validation activities to be managed more efficiently, audit evidence to be simplified and the effort for lifecycle validation to be significantly reduced.
What new regulatory requirements arise from the use of AI?
With the EU AI Act and new guidelines such as the ISPE GAMP® AI Guide, structured regulatory requirements for AI-based systems are emerging for the first time. Companies must in future demonstrate risk classification, model transparency, data quality, monitoring and governance structures when AI is used in GxP-relevant processes.
How does artificial intelligence change software validation itself?
In addition to the validation of AI systems, AI-supported validation processes are increasingly emerging, for example in test case generation, risk analysis or documentation. It is crucial that these technologies are used in a regulatory-controlled manner and continue to ensure traceability, data integrity and auditability.
How can companies permanently ensure their audit readiness?
Auditability is not created shortly before an inspection, but through structured governance across the entire system lifecycle. This includes clear validation frameworks, periodic reviews, data integrity controls and integrated change and release processes. Companies with such structures can face inspections much more confidently.
When is it worth modernizing the existing CSV strategy?
A review of the validation strategy is particularly recommended when:
- Introducing cloud or SaaS systems
- ERP transformations or system harmonization
- Increasing release and change cycles
- Growing system integration
- Using AI or data-driven applications
In these situations, software validation increasingly becomes a strategic management task.
Computer System Validation (CSV)