{"id":12588,"date":"2025-05-27T16:50:23","date_gmt":"2025-05-27T14:50:23","guid":{"rendered":"https:\/\/dhc.ima.vc\/zukunft-der-computersystemvalidierung\/"},"modified":"2026-05-09T23:51:31","modified_gmt":"2026-05-09T21:51:31","slug":"future-of-computer-system-validation","status":"publish","type":"post","link":"https:\/\/dhc.ima.vc\/en\/future-of-computer-system-validation\/","title":{"rendered":"Quo Vadis CSV? Future and Challenges of Computer System Validation"},"content":{"rendered":"\t\t
\n\t\t\t\t
\n\t\t
\n\t\t\t\t\t
\n\t\t
\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t\t
\n\t\t
\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Quo Vadis CSV? Future and Challenges of Computer System Validation<\/h1>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\n

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.<\/strong><\/em><\/p>\n<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t
\n\t\t\t\t\t\"Picture\n\t\t\t\t<\/div>\n\t\t\t\n\t\t\t
\n\t\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t\t\tDr. Rudi Herterich, Managing Director & Founder, DHC GmbH\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t\t
\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t

A Look back \u2013 How it all began<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

There are three experiences that have shaped my very personal relationship with Computer System Validation (CSV).<\/p>

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. <\/p>

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.<\/p>

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.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

\n\t\t\t\t\t
\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t

A Life-Changing Experience \u2013 This Is How It All Began<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

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?<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

\n\t\t\t\t\t
\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Underestimating the importance of software validation <\/h2>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

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:<\/p>

  1. Process knowledge: understanding of the affected business processes<\/li>
  2. Application knowledge: understanding of functions and their digital implementation<\/li>
  3. Risk understanding: where do potential risks to patient safety arise, and how can they be eliminated?<\/li>
  4. Regulatory competence: knowledge of the requirements that are examined in audits<\/li><\/ol>

    \u2192 More about DHC consulting services for software validation<\/strong><\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

    \n\t\t\t\t\t
    \n\t\t
    \n\t\t\t\t
    \n\t\t\t\t\t

    Validation as a Service \u2013 eine sinnvolle Alternative?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
    \n\t\t\t\t\t\t\t\t\t

    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?<\/p>

    What are the advantages of outsourcing CSV and using Validation as a Service<\/strong><\/a>?<\/p>