Building F.A.I.R. Data Foundations through ELN Compliance Design | Revvity Signals

Structured Data Compliance: Making Laboratory Data Findable and Reusable

One of the great advantages of utilizing an electronic laboratory notebook is leveraging configurations to enforce user compliance, especially in Good Laboratory Practice (GLP) or Good Manufacturing Practice (GMP) environments where meeting regulatory requirements becomes all the more crucial. For example, FDA 21 CFR Part 11 governs electronic recordkeeping, with rules about signatures, security, validation, and audits. GLP compliance adds more requirements such as those for data capture and reporting, Standard Operating Procedure (SOP) adherence, and quality assurance.

There are various approaches to building compliance into a scientific SaaS enterprise solution like an electronic lab notebook (ELN). Needs can vary depending on the type of organization. In some cases, the best approach is to design experiments so that all sections must be filled correctly. Other organizations emphasize the quality of content through robust QA/QC mechanisms, controls for data integrity, and training consistent with SOPs. A third approach emphasizes safety checks and hazard awareness, focusing on risk assessment, prioritization, mitigation, and communication.

How Compliance Technical Controls Enable F.A.I.R. Data Principles

While regulatory compliance drives many ELN configuration decisions, these same technical controls create a foundation for F.A.I.R. data principles, making laboratory data Findable, Accessible, Interoperable, and Reusable. This alignment isn't coincidental, as both compliance and F.A.I.R. principles prioritize data integrity, traceability, and long-term value.

Structured data fields and mandatory metadata go beyond satisfying auditors. They make experimental data discoverable years later. When researchers consistently tag experiments with project codes, compound IDs, or assay types, that data becomes searchable across the organization. Audit trails and access controls ensure data remains accessible to authorized users while maintaining security and chain of custody required by regulations like 21 CFR Part 11.

Standardized templates and controlled vocabularies, like those dropdown fields that ensure compliance, also enable data integration across systems and teams. When every chemist records reaction conditions using the same structured format, that data can feed directly into analytical tools, LIMS systems, or machine learning models. The data integrity mechanisms that prevent tampering also ensure future researchers can trust and build upon historical results, turning compliance documentation into a strategic data asset.

This dual benefit means organizations aren't choosing between regulatory requirements and modern data management. They're building both simultaneously through thoughtful ELN configuration.\

Structure for implementing compliance 

When developing compliance within an ELN, the biggest confounding factor is individual user preferences. Companies have shared several common refrains, including consistent use of data fields. Structured data fields can be leveraged for automating audits, streamlining data retrieval, and most importantly, enforcing consistency to ensure data quality. But if users don’t use them appropriately all the time, it becomes a headache for compliance.

The best way to address this is by designing the categories clearly, using tools like drop-downs and mandatory fields to ensure proper choices. ELNs like Revvity Signals Notebook include workflow templates that can be selected by the organization, which can make it straightforward to build structured data fields that meet all compliance needs.  

Another challenge cited by users is enforcing timely closure of experiments. Here, a structured but flexible approach can also help as mandatory workflows can be defined by administrators, including an experiment review workflow component. This means users cannot close experiments without a witness, making compliance checks simple via collaboration between managers and end-users. The structure of the workflows and additional layer of oversight can help ensure experiments proceed on schedule, and are logged properly.

Safety checks

By configuring the adaptable sign-off logic appropriately, companies can leverage the ELN to require user acknowledgments before the close of an experiment – for example, for hazards. Thus, ensuring compliance has the most direct and immediate impact on those users who handle hazardous materials. Implementing real-time safety checks for these researchers is a priority for every research and development organization.

Here, too, the ELN can be configured to ensure user compliance, as with automated jobs to check for hazardous chemicals in open experiments. In addition, manager dashboards can be developed to monitor flagged dangerous chemicals. 

Expert guidance for robust data governance implementation

Given how mission-critical data governance is, organizations must ensure that it is properly baked into their ELN. A purpose-built SaaS solution like Revvity Signals Notebook offers automated compliance workflow, data integrity assurance with robust security measures, and comprehensive documentation and audit trails. But research isn’t cookie-cutter, and so organizations’ requirements can vary – meaning compliance tools must be adapted to fit your requirements.

That’s where professional services fit in. To get the most from the solution’s scalability and flexibility, companies often turn to informatics service specialists who can work as partners to leverage all that an ELN has to offer in order to develop and integrate the right compliance solutions. Professional Services can support data governance and compliance needs with configuration documentation and validation. They can work with organizations starting before SaaS implementation and with continuous monitoring and support.

Revvity Signals’ Professional Services works collaboratively to address common data governance and compliance challenges. This starts from initial configuration, where the Revvity Signals team works with customers to meet their needs – for example by adding user groups, defining templates, or defining user rights and privileges. Once users have defined their requirements, the team collaborates with customers on performance qualification (PQ) or user acceptance testing (UAT) to objectively verify correct system configuration. The software is built to be verifiable, ensuring customers the product is consistently compliant-ready.

With more than 150 informatics service specialists, Professional Services is prepared to implement, monitor, support, and adopt customers’ SaaS solutions in compliance with GxP regulations, even embedding within their organizations when needed to support adoption. The Revvity Signals team can help with operational challenges like system maintenance and updates, relieving demand on internal IT teams.

Good Practice compliance is critical, and the right SaaS solution can reduce the burden on companies by making it straightforward to automate compliance, ensure data integrity, maintain audit readiness, and adapt quickly to regulatory updates. But it takes the right implementation, leveraging specialized compliance expertise – something Revvity Signals’ Professional Services have been built to provide. 

To learn more, visit Revvity Signals’ Professional Services to reach out or request a demo.

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