QFINITY · Service Areas · Process Management
Processes - the basis of every quality management system.
Process management makes quality-relevant workflows visible. In the GxP environment, a second meaning comes into play: the process is the starting point of validation. Only the process defines a system's Intended Use - requirements, risks, and the scope of validation all follow from it. That is why “we don't know our processes” is not an efficiency problem but a compliance problem: without a described process, no robust Intended Use - and without that, no defensible validation.
Quality processes
Who does what, when, how - and with what?
Process management means capturing, structuring, and actually living your quality-relevant workflows - from the company-wide process map down to the individual business process. The deeper reason for it is human: people can picture a process. You can point at a modeled process and talk about it - business, IT, supplier, and auditor are suddenly talking about the same thing. The approach is also anchored in the standards:
And process work is not rocket science: from the mid-sized manufacturer to the global pharmaceutical company, anyone can start today - with the tools already at hand.
An auditor will always approach an audit from the perspective of the process - because only a documented process that people actually follow can ensure GxP compliance.
Intended Use
Purpose originates in the process - not in the system.
Two levels the regulatory framework has kept apart for decades: the business process carries the purpose - the Intended Use. The technical system has functions that must fit that purpose (fit for purpose). A system does not know its purpose - it receives it from outside, from the process. That is why suitability can never be demonstrated on the code alone - only against the process the system serves.
In practice this means: requirements must be derived from the business unit's real processes - only then can system requirements be derived from them, and only then is it defined what any evidence is supposed to show. The cascade has four steps:
- 1
Capture the business process
Record the lived reality - not the wishful picture. This is where Intended Use and criticality originate.
- 2
Derive the business requirements
What the process needs from the system is defined by the business unit - not by a system's feature list.
- 3
Specify the system requirements
Derived from the business requirements and fully traceable - the specification pins down what exactly will be demonstrated.
- 4
Execute the lifecycle
Implementation follows the lifecycle model - always: specify, develop, implement, verify. Evidence focuses on the critical steps.
What is validated is not the software, but its application in the process - the regulations have said so, word for word, for more than two decades.
Process map
Master the process, master the quality.
The process map structures the company across three levels - from strategic governance, through the value-adding core processes, to the supporting activities. At a detailed level, you can then derive the IT process and service map - the basis for qualifying the IT infrastructure.
Above all, the end-to-end view of the process makes the data flow visible: where data originates, where it is handed over, and where it breaks. End-to-end processes pave the way for end-to-end data flows - the foundation of Data Integrity in the GxP environment and the substrate every AI works on.
Methods
Reality and model must match.
Capture & analysis
Modeling depth is not process mastery.
We capture your workflows with established methods - or with whatever tool you already use. The entry point is generic, the notation is yours to choose: this is not about fully modeled L1-L5 process landscapes, but about making who-does-what-when-how-and-with-what unambiguous.
There is exactly one quality criterion: lived reality and modeled reality must match - and that works best when you do not model down to the last level of granularity. A process model is as good as the match between model and reality - not as fine-grained as the mapping is.
- SIPOC: Supplier, Input, Process, Output, Customer - the whole process on a single page
- Turtle diagram: inputs, outputs, resources and metrics for each process
- Swimlane: roles, responsibilities and interfaces along the workflow
Into the AI world
What has served you well is also the load-bearing pillar for what comes next.
AI changes the technology, not the logic: a system that embeds AI still receives its purpose from the process it serves - and that holds for the entire digital transformation in GxP-regulated fields. Three things carry over directly from established process work into the AI world:
Intended Use & requirements
For an AI system, too, the requirements come from the business process: which task the model takes on in the workflow, how its suitability is measured - and where its limits lie.
Human Oversight
Human oversight is not a feature of the model - it is process design: review steps, roles, intervention points, and responsibilities are defined in the process. Responsibility stays with people.
End-to-end data flows
A model is only as reliable as the data flow that feeds it. Fragmented processes deliver fragmented data - processes understood end to end provide the substrate on which AI can work reliably.
How that turns into robust evidence is covered on our page on the validation of AI in the GxP environment.
The foundation
The process is in the definition - since 2000.
"Computerized System: A process or operation integrated with a computer system."
ICH Q7, Glossary (2000). The GMP framework for active pharmaceutical ingredients defines the computerized system as process plus technology - separate from the computer system (hardware and software). What is demonstrated includes the process by definition - and has for a quarter of a century.
Our position
Process understanding is not groundwork for validation - it is its core. That is why every validation at QFINITY starts with the process. And so does every AI introduction.
Our service
Process management that delivers GxP compliance.
From the mid-sized manufacturer without a dedicated process team to the global corporation with a landscape grown over years: we bring the method, you bring the knowledge of your workflows - no mega-project, no forced tooling.
Capturing, analyzing and documenting processes - including basic requirements and risk mitigation
Conducting process audits, e.g. for special processes in the clinical setting
Developing and optimizing process validation, e.g. for medical devices
Developing process management systems for IT (as part of computerized system validation)
Establishing processes in the GCP environment
Introducing and optimizing QM processes: CAPA, document, change and risk management
Developing a quality management manual
Process audit
Process validation
QM manual
CAPA
Document management
Change management
Risk management
GCP processes
FAQ
Common questions about process management.
No - AI needs understood processes. The process remains the place where purpose, requirements, and responsibility originate, even when a model takes on parts of the work. What is new are specific control points such as Human Oversight and the data flows for training and operation - the logic of deriving them from the process is the same as it has been for decades.
Detailed enough for lived reality and model to match - and no deeper. A process landscape modeled down to the last level of granularity goes stale faster than it can be maintained - and loses its evidential value. A deliberately limited model that is right beats a detailed one that no one can keep current.
Because criticality is a property of the process: only an understood process shows which steps and functions carry product and patient risk. Evidence can then be concentrated where it has probative value instead of testing across the board - exactly what risk-based approaches from ICH Q9 to the CSA guidance build on.
No. The entry point is generic and the tool is yours to choose - from a facilitated workshop to simple diagrams to the BPM system you already run. What matters is not the notation, but that everyone involved can point at the process and talk about it. That is why getting started works for a mid-sized company just as it does for a global corporation.
More from our service areas
Processes work best together.
Start where you are.
Whether it is your first process map or a grown landscape where reality and model need to find each other again: we capture your quality-relevant workflows and turn them into the basis for requirements, validation, and AI deployment. Free of charge, about 30 minutes.
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