QFINITY · Service Areas · Digital Transformation
The digital transformation in GxP-regulated fields.
Digital transformation in a GxP-regulated environment changes the organization as a whole - ways of working, methods and tools whose outcomes ultimately affect patients; digitalizing individual use cases is a building block, not the goal. What slows it down is rarely regulation, but rather misconceptions: that more documentation creates more safety, and that inspectors expect the most comprehensive paper-based evidence possible. Neither assumption is professionally tenable. We place people and the processes they are responsible for at the center - and establish methods that enable innovation rather than prevent it.
Digital Transformation
Technology follows the process - not the other way around.
New technologies bring new challenges and call for new ways of thinking. To strike the right balance between cost and benefit, you have to question long-established quality approaches - with the whole quality organization behind the effort. The starting point is always the process: it defines a tool's intended use, and from there follow requirements, risks and the depth of evidence. Tools and systems should support the ways of working that emerge, not dictate them.
To scale the planned measures correctly, you need a realistic view of where you stand - and of your ability to implement digital strategies.
The Lever
What really holds transformation back?
Rarely the regulations. Usually it is two assumptions from within the organization - and neither has a regulatory basis:
This is exactly where the lever sits: record-based, tool-supported methods create the evidence where it comes into being - as records in the tool instead of in downstream documents. The goal of the evidence stays the same; the route becomes more efficient. And only such methods make innovative ways of working possible: AI-supported work, agile development, CI/CD. Where every piece of evidence is transferred into downstream documents, short release cycles cannot be sustained - record-based methods support them.
Record-based
Tool-supported
Risk-based
AI-supported
Agile
CI/CD
Regulatory Landscape
The regulations confirm the path.
The regulations themselves are taking the risk-based, digital path - in pharma and medical devices alike. Four examples show how much they explicitly enable: the use of tools, digital records, and an ordered framework for AI.
| Framework | What it enables |
|---|---|
| FDA Computer Software AssuranceGuidance for production and quality system software · final 09/2025, QMSR edition 02/2026 | makes risk-based, tool-supported assurance the program: the framework explicitly covers automation, data analytics and AI/ML tools as well as cloud computing - and as evidence the FDA recommends digital records (system logs, audit trails, data generated by the tool) over paper documentation, screenshots and duplicated results |
| EU GMP Annex 11Pharma · in force since 2011, revision in draft (2025) | provides for tool-supported testing today: "automated testing tools and test environments" have been explicitly foreseen since 2011, with a documented adequacy assessment as the requirement; the current draft revision of Annex 11 stays on this line and literally calls tools for requirements traceability and audit trail review "encouraged" |
| EU GMP Annex 22Pharma · new, draft (2025) | gives AI in GMP a solid framework for the first time: with static models and deterministic output, AI becomes plannable even for critical applications; generative AI remains possible in non-critical ones - with qualified personnel responsible for the suitability of every output (human-in-the-loop, HITL) |
| EU AI ActEU law · in force - obligations phase in over time | created to protect people in the EU - health, safety, fundamental rights - and, just as explicitly, to promote trustworthy AI; horizontal across all sectors. Little is prohibited: a narrowly circumscribed set of practices with defined exceptions. Everything else the AI Act orders by risk - from high-risk obligations to transparency rules - making the requirements predictable. The Digital Omnibus (in force from 27 July 2026) further simplifies implementation and eases the timelines |
None of these frameworks prohibits innovation - they order it by risk. Build your methods on that order, and regulation is no longer a hurdle in front of you but a confirmation behind you.
Maturity Assessment
Requirements first, then the tool.
WHY before HOW
Maturity before roadmap.
Digital transformation starts with people and the processes they own - not with technology. Culture shapes people, people shape processes, and processes draw on the tools. Your honestly assessed maturity decides how big the next step may be - only then does the technology decision fall.
- Status analysis: an honest read of your maturity - strengths, gaps, capacity to deliver
- A quality culture that makes room for critical thinking and involves people directly
- An intended use and risk-based evidence for every tool - derived from the process
From Practice
We have walked the road from document-based to record-based ourselves.
For more than two decades we have validated the use of computerized systems - from ERP, DMS, LIMS and MES to cloud platforms, from document-based to record-based methods. To us, modernization is not a concept paper - it is a craft.
How AI is changing validation is something we recently described in Pharmaceutical Engineering: "How AI Will Transform Computerized System Validation" (Herrmann/Henrichmann, Jan/Feb 2026).
Our Position
Over-documentation is not a gain in safety, and fear is not a compliance strategy. Evidence gains strength not through volume but through precision: record-based, tool-supported, aligned with risk.
The goal is unchanged: solid trust in processes and products. Only the route there is more efficient today.
Our Service
Transformation, led with ownership.
From the initial maturity assessment through strategy to rolling out innovative technologies - we guide your digital transformation across all three levels: people, processes and tools.
FAQ
Frequently asked questions about digital transformation.
No. The regulations demand risk understanding and controlled processes - not maximum documentation volume. What slows transformation down are usually a company's own assumptions: over-documentation as supposed safety, and fear of the inspection. The regulations themselves are taking the risk-based path - from the FDA's CSA guidance to the drafts of Annex 11 and Annex 22.
Yes. No regulation prohibits tool-supported validation - quite the opposite: the current Annex 11 has explicitly provided for automated testing tools since 2011, the FDA confirms the route with the CSA guidance, and the draft Annex 11 stays on this line - tools for requirements traceability and audit trail review are literally "encouraged". What counts is the evidence, not the medium: record-based methods create the evidence where it comes into being, and they are more efficient than downstream documentation. The prerequisites are a defined intended use and a risk-based approach for each tool.
Yes - it is not prohibited outright; it wants to be approached wisely: through governance, defined use cases and risk analyses. That is exactly the order the EU AI Act lays out, and the draft Annex 22 formulates GMP expectations for AI for the first time. Where limits apply - under the draft Annex 22, generative AI should not be used in critical GMP applications - they follow from risk, not from a blanket ban: in non-critical applications its use with a human-in-the-loop is explicitly foreseen. What this looks like in practice is shown in our topic area Artificial Intelligence in GxP.
Not every one - and never the tool alone. What is validated is the application in the process: the process defines the intended use, and risk and depth of evidence follow from it. A tool with no influence on the chain from data to product to patient needs no validation effort; a critical one needs targeted evidence instead of maximum formality.
The groundwork for every investment decision. It shows honestly where culture, processes and systems stand and what capacity to deliver exists. The result is a roadmap that fits your maturity - instead of a technology decision without a foundation.
Start with an honest maturity assessment.
In an initial conversation we place your maturity and name where record-based, tool-supported methods will get you to your goal faster - before any technology decision is made. Free of charge, about 30 minutes.
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