Quo Vadis CSV? Future and Challenges of Computer System Validation
A contribution by Dr. Rudi Herterich, founder and managing director of DHC, on the evolution of computer system validation (CSV) and how it will change in the age of cloud and digitalization.
A Look back – How it all began
There are three experiences that have shaped my very personal relationship with Computer System Validation (CSV).
A few months after DHC was founded in 1996, the first go-live at the country subsidiary of a pharmaceutical corporation was approaching, and we were planning the go-live party. Interestingly, the QM manager declined to attend because “the R/3 system had not been validated.” A brief research session (Google did not exist yet at the time) on the topic of “validation of computer systems” led me to a five-day training course at Concept Heidelberg. We decided to invest in this topic, and I had to attend. The course was fully booked with a good 50 participants, which surprised me: there must be significant interest in this topic. We learned about the V-model, the correlating document types and the required approach.
For me as an R/3 implementation consultant, the question was how this methodology could be applied to a highly complex, integrated IT system. Two aspects seemed important: first, to determine which functions are actually GxP-critical and then how to validate them according to the V-model. The approach therefore had to be risk-based and process-oriented.
I took this idea to the speaker, Dr. Wolfgang Schumacher, during lunch. He acknowledged the idea without comment, which was disappointing at that moment. The surprise was all the greater when he called me about six months later and asked whether we would like to support him in validating R/3 systems at various plants. Of course we wanted to, and this marked the beginning of a business relationship that lasted many years.
A Life-Changing Experience – This Is How It All Began
Another formative experience occurred during a pitch at a major medical technology company. After presenting our approach, the board member commented verbatim: “So from now on we are just making paper black?…” An expression of incomprehension about the perceived documentation burden. For us, the impetus to put CSV to the test: Where does it truly benefit a company?
Underestimating the importance of software validation
The fundamental idea of computer system validation is anything but trivial: it is about providing an IT system that meets requirements, is documented and tested, to ensure patient safety. This is complex and interdisciplinary. Required are:
- Process knowledge: understanding of the affected business processes
- Application knowledge: understanding of functions and their digital implementation
- Risk understanding: where do potential risks to patient safety arise, and how can they be eliminated?
- Regulatory competence: knowledge of the requirements that are examined in audits
→ More about DHC consulting services for software validation
Validation as a Service – eine sinnvolle Alternative?
If you want to deliver more than just expensive audit readiness to authorities and customers, CSV is a demanding task for specialists who generate significant added value. However, such specialists are hard to find on the market and certainly not inexpensive. This presents smaller companies in particular with major challenges and raises the question of whether it is economically sensible to maintain an “in-house” validation team. Cloud computing and application management have long arrived in IT, so why still maintain a validation team?
What are the advantages of outsourcing CSV and using Validation as a Service?
- Expertise and standardized solutions from the service provider
- Economies of scale through bundling similar tasks
- Cost efficiency in tools, resources, and fluctuation
- Relief of internal resources while maintaining compliance assurance
- Risk avoidance of resource shortages and fluctuation
→ More about Validation as a Service
Innovation Pressure Grows – and CSV Must Keep Up
The most important argument for operating CSV as an “extended workbench” is the tremendous dynamism currently taking place in IT. Cloud computing is fundamentally changing the IT landscape. Innovation cycles are getting shorter: While a release change of major ERP systems previously required a six-month re-validation, providers like SAP are moving toward three-month innovation cycles. CSV must not become a showstopper. With the traditional, largely manual approach, this dynamism cannot be managed. What regulated industries need now is a largely automated validation process, fast, reliable, and audit-proof.
DHC is driving digital validation forward
DHC has been working on digital, automated validation solutions for the life sciences industry for years. Our specialist teams support companies in operating quality-assured, valid systems at all times. Together with SAP, we are currently developing approaches to closely integrate innovation and validation processes.
End-to-End Digital Validation Platform and DHC Smart Validation Accelerator
With the initiative “End-to-End Digital Validation Platform (E2E DVP)”, SAP has taken a decisive step toward future-proof validation. The goal is to create a seamless connection between system implementation and validation, throughout the entire lifecycle. Both classic on-premise solutions and modern, modular cloud architectures such as SAP S/4HANA, SAP BTP, and SAP Cloud ALM are considered.
At the center is a clear strategy: The shift from monolithic ERP systems to flexible, cloud-based solutions requires a new validation logic, automated, scalable, and audit-proof.
A central component of this toolchain is the “DHC Smart Validation Accelerator (SVA)” developed by DHC. This solution enables the automated creation, management, and adaptation of validation content for GxP-relevant systems, across all phases of the system lifecycle. Technical functions are linked to the relevant business processes on a risk-based and process-oriented basis. The result: transparent, audit-ready documentation that meets both regulatory requirements and the expectations of business departments.
→ More about the DHC Smart Validation Accelerator (SVA)
Computer System Validation (CSV) – The Future and Challenges
Would you like to learn more about the SAP initiative” End-to-End Digital Validation Platform (E2E DVP)?
