In a world flooded with data, knowing what matters and protecting it is the new frontier in validation. Not all data is equal. Understanding which records truly impact product quality, process integrity, or patient safety is essential to achieving both compliance and efficiency.
At IPS, we leverage Kneat’s digital validation platform to help our clients identify, classify, and protect their most critical data, ensuring integrity and traceability across the entire lifecycle. Kneat provides a single source of truth for validation records, enabling real-time visibility, secure documentation, and audit-ready traceability.
Embedding these capabilities into validation workflows, enables organisations to move beyond manual, paper-based systems and toward a smarter, future-ready approach. Unlike general consultants, IPS brings deep life sciences expertise and hands-on validation experience to every Kneat implementation.
Identifying Your Data
Identifying an organisation’s data may seem simple, but it is often undervalued. While teams usually recognize the obvious data points tied to product release, quality, and efficacy, many other critical records are overlooked, despite being invaluable to daily operations.
This identification process is typically part of an assessment when implementing a new system or process, but it can also be carried out retrospectively for systems already in
place. With deep life sciences expertise, IPS ensures that this exercise is thorough, helping organisations capture all critical data and avoid costly gaps.
- Assemble a team – Engage SMEs who know the system or process to ensure thorough, accurate results.
- Document the discussion – Capture notes, forms, or documentation and validate accuracy by sharing with the team.
Expert Tip: One of the most effective methods for identifying data is workflow or data-flow mapping. Visual tools such as whiteboards or sticky notes help teams better understand the "ins and outs" of a process and the data it generates.
Kneat strengthens this approach by providing a structured, digital repository where identified data can be documented and linked directly to validation workflows.
Classifying and Categorising Your Data
Once identified, data must be classified to determine its relative importance.
Classification is typically stratified based on the data’s impact on:
- Critical Quality Parameters (CQP) or Critical to Quality
- Critical Process Parameters (CPP) or Critical to Process
- Critical to Patient outcomes
Scales such as High/Medium/Low or Red/Yellow/Green can be applied. From here, categorisation leads to clearer insights into Impact, Risk, and Criticality:
- Impact: Direct impact if data affects product, process, or patient; otherwise, no impact.
- Risk: Often subjective but usually determined by impact and whether data is an input or output.
- Criticality: Organisation-specific, but derived from impact and risk, grouped as High, Medium, or Low.
At IPS, we enhance this process by applying our structured, risk-based approach to classification across systems and projects. Leveraging Kneat’s configurable templates and built-in traceability, our teams ensure classifications are applied consistently, aligned with regulatory expectations, and supported by real-world validation expertise.
Once completed, the Impact, Risk, and Criticality should map back to requirements in policy to determine the appropriate due diligence or steps required to ensure the security, fidelity and integrity of the data.
From Classification to Transformation
At IPS, our strength lies in the depth of our life sciences expertise and the people behind our projects. Our teams bring decades of experience in commissioning, qualification, and validation, with many having worked directly within biopharma and advanced therapy organisations. This knowledge allows us to understand not just the regulatory requirements, but also the practical realities of running complex facilities and delivering life-saving therapies.
When paired with Kneat’s platform, this expertise delivers measurable results. Kneat digitises and automates validation workflows, reducing cycle times, improving data integrity, and providing complete audit trails. IPS ensures those digital tools are implemented in a way that reflects real-world processes and compliance needs, so clients gain not only a technology solution but also a best-practice framework that drives lasting transformation.
It’s this combination, an exclusively life sciences focus, delivered by experts who’ve lived the challenges firsthand that makes IPS uniquely positioned to guide clients through validation and their digital transformation journey.
