GxP consulting that bridges strategy and delivery.
GxP consulting connects what the regulations require of your processes, data and systems with what your team can realistically sustain in daily operation. We analyze your business processes, develop the solution together with you and pass on what we know along the way.
How does the right approach emerge from where you stand?
It starts with taking stock. We look at how your business processes run, what data they produce, how your quality assurance works and which IT landscape underpins all of it. From there we derive what the regulations require. Those requirements are fixed. The route to meeting them depends on your organization's current maturity. We work out the system requirements in requirements engineering, and the impact analysis shows what they trigger in your existing systems. We set the order of the requirements on a risk basis. ICH Q9(R1) guides how quality risk management is approached, and the industry standard GAMP 5 informs the method. That yields a master plan covering time, resources and responsibilities. A system with a direct impact on product quality and patient safety calls for more evidence in that plan than a supporting tool does. At the end of this phase you have a documented approach that justifies the sequence and puts a figure on the effort for each step.
How a consulting project runs.
Five steps build on one another. Each step ends with a result you can review before the next one begins.
- 1
Understand the situation
We walk through your processes with the people responsible, look at the systems and data behind them and record what falls within GxP scope.
- 2
Analysis & requirements
Impact analyses, business process analyses and requirements engineering produce the requirements, while the risk assessment justifies the testing scope for each of them.
- 3
Strategy & master planning
From the analysis we derive the master plan, complete with schedule, resource plan, solution design and implementation concept.
- 4
Implementation & validation
We support your team in planning, running and documenting the validation, while assessment, residual risk and release stay with your company. The evidence produced for each system follows from its intended use, requirements and risk classification.
- 5
Enablement & transfer
We hand over the documentation, the decision trail and the open items to your team, so the knowledge stays in-house and your team can sustain the solution after the project ends.
What does an external sparring partner deliver?
We bring an outside perspective without taking responsibility off your hands. That responsibility stays with the regulated company, as the regulations stipulate. We provide the basis for your decisions and a second professional opinion on disputed issues. Our specialists share in the implementation work where process, data and system meet.
What our GxP consulting encompasses.
The reasons vary. An inspection has revealed deficiencies that must be remedied, a new system is due to enter GxP operation, a QM system that has grown over the years no longer shows the path from requirement to evidence, or a first product is entering the regulated market. You can call on these eight services individually or as a package.
What we measure ourselves against.
Two questions show whether our work has succeeded. Are your processes simpler to run afterwards, and can your team explain the evidence in an inspection on its own?
- The effort for each step is set out in the documented approach before implementation begins
- Decisions are documented with their reasoning, so your team can retrace and adjust them later
How we round out our consulting.
We assess where you stand.
In a free intro call of about 30 minutes, you describe your situation and we tell you which step comes next.
Book an intro call
