Building transparency into lab activities and creating stronger connections between the development of experimental data choices and final product outcomes can be tough. Product lab trials are fiercely protected-—and frequently isolated from the rest of the product lifecycle.
Product scientists are focused on product innovation, not on record-keeping. Lab results often remain locked away in specialized electronic lab notebook (ELN) systems, databases or data formats, making product insight and development choices hard to extract and analyze by compliance, legal, quality assurance teams and other business units.
Tracking decisions and product data during product testing and development is absolutely critical for patent and legal protection, as well as internal knowledge sharing across working groups. Having a connected ELN solution that flows into the rest of the PLM process isn’t just a nice-to-have. It’s essential for more efficient product innovation and traceability in legal compliance.
The Limitations of ELN-Specific Tools
Many process-based companies already have an ELN solution in place in their labs. Capturing product data as it is created isn’t the issue--it’s that ELN tools are typically implemented as a lab-level system and fit for product scientists’ specific workflow and lack the framework for complete product traceability.
Most notebook-type systems provide the ability to capture experiments, attach documents, write comments and enter info, but don’t neatly connect experimental data to specification and final product development. Labs may also use ad-hoc solutions for ELN such as EverNote, Lotus Notes or Excel-based methods. Again, this is a functional solution for product scientists, but tracking, accessing and using this information beyond the lab remains difficult both due to the format of data and its use a siloed lab tool.
When ELN processes and tools remain isolated from the other operations, demonstrating the progression of product prototypes and trial results becomes increasingly difficult. Later product iterations may contain missing or inaccessible data, and product decisions aren’t immediately obvious to other business units. As a result, process-based companies end up bringing in more significant risks to their data integrity and make it more challenging to prove exact details needed for legal compliance and knowledge sharing.
Using PLM to Facilitate Electronic Lab Notebook Activities
Instead of using an ELN tool, PLM systems such as Trace One Devex PLM can achieve the same functions with the added advantage of interconnected product data templates that take compliance and authorship into account before trials even begin. With PLM systems, you can both capture and share results of experiments and easily demonstrate why product choices were made, and by whom.
A PLM system contains all the data fields for full product lifecycle management, with the ability to:
- Capture detailed experimental data and product trials and in an easy-to-use and customizable template with data fields built for complete product lifecycle management.
- Digitally document product innovation and which steps were taken to reach desired product outcomes.
- Document institutional and specialized knowledge across R&D experiments, trials and decision points.
- Efficiently document authorship and creation dates and times to avoid falsification and patent claims.
- Directly connect product research data to finished product specifications, creating full visibility and traceability into product decisions throughout the lifecycle.
Using a PLM system as a robust ELN solution not only helps companies centralized experimental and finished product data together, but it also cuts down on the number of specialized solutions that need to be purchased and maintained to support testing and development.
Recording More That Just Trial and Experiments
Managing lab processes isn’t just about writing down linear results. When using a PLM solution for lab activities, you’re not just documenting product data; you’re recording the full thought process that your product experts go through during the invention and innovation steps.
Trace One Devex PLM offers multiple enhancements that streamline product innovation:
- Track product variations and user intent created during product trials. When you start a project, you can attach an experiment to a project template within Trace One Devex PLM and track any number of tests within the experiment template, connecting the dots of scientific choices.
- Capture Authorship. Trace One Devex PLM organizes individual trial results and readings, including document attachments, written notes and test results, and ties those results into experimental product templates. Capturing when, where, how and who created product data with date stamps and more provides a complete view of product authorship.
- Create Individual Trials. Trace One Devex PLM manages every single product iteration in one place with specification data fields captures trial results in context with
- Work with Multiple Samples. During product trials, scientists can create, capture and label multiple product samples, recording which ingredients were used and clearly delineating the evolution of product variations.
- Compare Results. Trace One Devex PLM enables scientists to set data limits at the point of testing, meaning product variations and samples are created with regulatory requirements in mind from the very start.
With a PLM system, scientific development is bolstered by built-in workflows and product templates and better protected for patent claims.
Seamless Data and Knowledge Transfer
As the innovation process progresses through product scientist’s groups, marketing, quality assurance, compliance and other operations, managing the sequence of decision making is just as important as accurate data capture. A PLM-driven lab process can more clearly reflect the choices made during product development, prove intentions and promote more efficient knowledge sharing.
Unlike stand-alone ELN tools or Excel methods, Trace One Devex PLM supports the capture and use of both free text and embedded documents as well as structured data and search. This feature makes experimental data searchable and usable across the product lifecycle, painting a clear picture of how trial activities affect final products.
Within Trace One Devex PLM, entire trials can be copied and modified, saving time on busy work and maintaining accurate data as experiments progress. The system inherently tracks product iterations and all the decisions made during each trial. Furthermore, experimental and approved data can be plugged directly into ingredient, formula and finished product specifications contained with the same system.
As a result, the creative thought process used by product scientists is more transparent and more easily proven for legal compliance.
Built-In Regulatory Auditability
Proving that FDA requirements for product innovation have been met within a lab setting can be an arduous task without enterprise-level recordkeeping. Process-based PLM systems offer built-in regulatory controls over the entire lab process and cut down on manual data tasks for both product scientists and compliance teams.
In addition to tracking authorship of trials and experiments, Trace One Devex PLM can:
- Use built-in audit trails to track detailed changes made to product data.
- Record lab tests as structured data using the Test Module or with built-in document management.
- Use check-in/out features to monitor who is accessing documents and control data modification or access.
- Automatically compare product specification data against regulatory limits to ensure compliance with product innovation.
- Archive past results and upload new results, enabling a full overview of past and new data together in one place.
- Use witnessing workflow processes and electronic signatures to track approvals and decision points.
Using a PLM system to facilitate traditional electronic lab notebook tasks bring controls, transparency and efficiency to product data starting at the point of experimentation. Connect your lab trials to the rest of product development and bring scientific choices to the forefront of your compliance activities with Trace One Devex PLM.