In laboratories around the world, data generation is exploding. Whether you're conducting toxicology studies, testing agrochemicals or validating materials in environmental studies, chances are your lab is producing terabytes of data - some by hand, but increasingly through computerised systems.
But here's the rub: this tsunami of data must not only pass scientific scrutiny but also meet stringent quality standards. Since the OECD published its revised Principles of Good Laboratory Practice and Compliance Monitoring (ENV/CBC/MONO(2021)26), the bar has been raised. While many of the expectations are familiar from the GMP environment - such as traceability and data integrity - application in non-clinical laboratory studies introduces unique complexities.
Unfortunately, most scientific staff don't have a background in IT systems or data lifecycle management. Instead, they rely on fragmented workflows, storing files on personal drives, USB sticks or shared folders with inconsistent naming conventions and unknown version histories.
What this creates isn't just inefficiency. It creates risk - scientific, operational and regulatory.
Many labs still operate in what regulators now call a "static" data environment. Think of printed reports, PDFs stored on local machines or exported CSV files stored in an inbox. These documents are fixed, non-interactive and isolated from their original context.
In contrast, the OECD guidelines encourage the adoption of "dynamic" records - digital formats that retain interactivity, links and traceability. A chromatography file, for example, should not only contain the peak data; it should also allow zooming in on baselines, revising integration parameters and reviewing the entire analysis sequence. Most importantly, it should be linked to metadata: who did what, when, why and how.
This shift isn't just technical. It ensures that any data used for decision making - especially in regulatory submissions - is verifiable, reproducible and auditable.
All too often, laboratory data management is equated with simple storage - filing files in folders and making backup copies. In reality, the OECD guidelines promote a lifecycle approach to data: Every piece of information goes through a journey that needs to be documented, protected and managed at every stage.
Identify data worthy of archiving
Only GxP-relevant data must be archived in accordance with e.g. GMP/GLP:
- Raw data (e.g. peaks, spectra)
- Result data (e.g. calculated concentrations)
- Metadata (date, time, user)
- Audit trails (change history)
- Context data (e.g. method settings, calibration information)
Archiving usually takes place in several automated or semi-automated steps:
1. Data capture on the device / software
Data should be collected directly from laboratory instruments - ideally in real time - and accompanied by metadata (e.g. instrument settings, operator ID, time stamps). This minimises the risk of error and improves traceability.
2. Completion and signature by authorized users (approval)
Before becoming part of the official study record, data must pass through quality control (QC) workflows. Has the method been validated? Were there any anomalies in the result? Has the data been reviewed and approved by the responsible person?
3. Processing: export to an archive format (e.g. PDF/A, XML, secured with hash values)
Analysis software can interpret or refine the data. This phase requires version control and full transparency - what has been changed, by whom and why? Otherwise, the data can quickly become unreliable.
4. Migration / transfer to the archive system under access control
Data often needs to move - from a lab computer to a network drive, or from proprietary formats to open ones. Each transfer and transformation must be traceable and validated to prevent loss or corruption.
- Version control
- Time stamping
- Access logging
5. Archiving / Long-term storage including backup, version management and audit trail
Final repositories must guarantee integrity for years or even decades. Regular audits, file integrity checks and documentation of access or movement are essential to ensure compliance.
Important: Not only the measured values themselves, but also audit trails, method parameters and metadata must be archived!
The diagram visually maps this lifecycle and is an excellent resource to share with laboratory staff who are new to these concepts.
Consider a simple example: a set of temperature readings from a stability chamber. Without metadata, we don't know which chamber they came from, who calibrated the sensor, or which sample the readings belong to.
Metadata turns isolated data into actionable knowledge. It identifies, describes and links records so that they can be interpreted not just today, but years from now. This is particularly important for long-term storage and advanced analytics, such as artificial intelligence or machine learning, which rely heavily on high-quality, well-structured datasets.
In short, metadata is the oxygen of digital compliance.
One of the core frameworks for data integrity is ALCOA+:
• Attributable: Every entry must link to a person.
• Legible: Clear and understandable for others to review.
• Contemporaneous: Recorded in real-time.
• Original: Not rewritten, retyped, or copied.
• Accurate: Reflects the actual observation.
• Complete, Enduring, and Available: Self-explanatory but often overlooked.
These principles apply equally to paper and electronic records. But digital systems must also provide audit trails - automatic logs that track every change, who made it and why. A PDF exported from Excel doesn't count unless the source file and change history are also retained.
Given the complexity of managing data across this lifecycle, expecting scientists to do this manually is unrealistic. Compliance today requires automation, not more effort.
Watcher 4.0, a platform developed by biomedion GmbH, is designed precisely for this challenge. Built with modular components:
• WATCH+ captures data automatically as it leaves the instrument or file system.
• IMAGE+ enables seamless visualization and annotation of lab images, even across uncommon file formats.
• SIGN+ (optional) supports digital signing, approval workflows, and regulatory reporting.
The system takes over tasks like files transfer, archiving, audit logging, and data integrity check—all while aligning with OECD and FDA expectations. For scientists, it reduces friction. For quality teams, it delivers traceability. And for organizations, it ensures audit readiness with minimal overhead.
In the past, data compliance was considered the responsibility of quality managers or IT administrators. But as the regulatory focus shifts to data-centric inspections, every lab professional becomes a stakeholder in data integrity.
You don't have to be an IT specialist. But you do need to understand how your actions - from how you save a file to how you document a calibration - affect your lab's overall compliance posture.
Start by adopting basic best practices:
• Save data in structured formats.
• Never edit original raw data; annotate instead.
• Use standardized file naming conventions.
• Tag every dataset with sufficient metadata.
• Work with tools that support your workflow—not against it.
Modern laboratories are digital ecosystems. With the right tools and mindset, you can ensure your science stands the test of time - and the scrutiny of auditors.
The OECD’s updated GLP guidelines set a new benchmark for data integrity, traceability, and compliance in a GxP-driven world. Laboratories that continue to rely on outdated or manual processes risk non-compliance, inefficiency, and data integrity challenges.
With biomedion’s Watcher 4.0, you can simplify GLP-compliant data management – no IT expertise required. Designed specifically for regulated environments, Watcher 4.0 ensures secure, audit-ready data handling and long-term archiving, giving your laboratory the confidence to meet evolving regulatory expectations.
Now is the time to modernize your laboratory data management and future-proof your operations. Contact us today to learn how biomedion can help you achieve seamless GLP compliance.