"Validate smartly, not excessively"
We don’t just churn out CSV documents; we deliver full-spectrum compliance, ensuring your entire project aligns with internal rules, legislation, and industry standards—all while keeping your timelines and scope intact. That’s the baseline.
Our mission goes further: to redefine CSV by delivering tailored, demand-driven validation that truly reflects your needs. We refuse to burden you with bloated, generic validation rules or cling to so-called "best practices" that add no real value to patient safety, product quality, or system reliability. We focus on optimizing and streamlining your validation process to ensure efficiency, precision, and compliance without unnecessary complexity.
We will concentrate on optimizing your validation methods, not simply completing them!
Discover a smarter approach to validation. We don't just improve processes—we regenerate them, ensuring they work harder and smarter for you. By asking the tough, often-overlooked question, "Does it really need it?", we help you streamline without compromise. Our mission is to guarantee that you achieve the same level of complexity, but with significantly less effort.
Let us transform your validation with our our T.H.R.I.V.E™ process into a model of efficiency and effectiveness. It’s time to do more with less.
Experience the power of a streamlined validation approach with our proven six-step method:
Defining and summarizing of specific objectives and optimization strategies to simplify the validation process.
In this first
step, we assess if, how, and to what extent a new validation process should be introduced or an existing one improved—ensuring
efficiency, compliance, and cost-effectiveness from the start.
Collecting and organizing of information such as SOP “quality”, quality of the document frameworks / templates used, process images, and a thorough review of the status and efficiency of the documentation and validation processes. As a rule, ITIL management, test management, CAPA and general compliance robustness are also included in this analysis.
Development of an optimization approach plan for the processes and tools defined in the previous steps.
It must be
ensured that the process to be optimized or introduced remains lean but compliant, that existing tools are properly
integrated, that new tools are only used where they bring a real advantage and that there is a measurable
improvement.
Your strategy is in place—now let’s bring it to life. Our team will be happy to help you execute the pre-developed
optimization plans.
Whether you need support for your existing teams, a hybrid approach or full implementation support
from us, we'll ensure smooth execution and measurable results.
Conducting of thorough reviews and assessments to confirm that all documentation meets predefined standards and that validation activities are properly recorded and compliant with regulatory requirements.
Assessing of the overall effectiveness of the documentation and validation processes, identifying areas for improvement and implementing corrective actions to enhance future project performance.
We help you to find the most intelligent and practical tools for your document management or test support.
Still Using Word or Excel? It’s Time to Evolve!
Are you still relying on Word, Excel, or even printed documents for your processes? It's time to take the technological leap—not just in production, but across all areas of your operations. Modern tools can revolutionize your approach, saving you time, reducing costs, and boosting efficiency.
Let us show you how these advancements can transform your processes. Take the first step towards smarter, streamlined solutions today!
Introducing T.H.R.I.V.E™: A Smarter Approach to Validation
In today’s rapidly evolving pharmaceutical industry, maintaining a robust and compliant validation process is more critical than ever.
Why Optimizing Validation Processes is Crucial
Looking back to my first days 15 years ago, the effort required for validation was, let’s call it, different.
Rethinking validation: a fresh start.
For us, it was time to rethink the way validation is done. We set out to transform validation into a seamless, collaborative and impactful process.