Use case 2: Manage internal annotations

This use case involves handling internal notes for the development of a new assay. Throughout the process, the team uses the Note document type to maintain detailed, time-stamped internal comments and observations that enhance collaboration and traceability within the team.

We meet members of the Stegmann Labs team, a fictitious contract laboratory where PLA 3.0 plays an essential role in every step of bioassay analysis.

Challenges and step-by-step solutions

Xiaoling, the QA specialist at Stegmann Labs, collaborates with Alice, the Senior Laboratory Technician, and Emily, Alice's manager and Senior Research Scientist. Each member has a distinct role:

  • Xiaoling oversees quality assurance and ensures compliance with documentation and regulatory standards.

  • Alice conducts the initial experimental setup and performs hands-on data collection.

  • Emily supervises the project, reviews key findings, and provides strategic guidance on assay optimization.

As the team encounters challenges, such as unexpected anomalies during data acquisition or adjustments required for experimental setups, they rely on the Note document to keep track of the progress. Here's how they do this step by step:

No. Functionality Details

1

Documentation of findings

Alice records specific findings during experiments that require further investigation such as a particular reagent causing variability in results. These findings let the team trace issues back to their root cause.

2

Team collaboration

Xiaoling reviews Alice's Note document regarding quality concerns that need to be addressed. Emily adds strategic insights such as a modified dilution sequence into the same Note document, facilitating a seamless exchange of information among team members.

3

Attachment of context

Each Note document is linked to the related assay document, providing clear context for future reference. When Emily reviews the data weeks later, this lets her trace findings back to their related experiments without needing to sift through unrelated information.

4

Compliance and audit trail

With built-in traceability features, every change to the Note document is time-stamped and linked to the user who modified it. During an internal audit, Xiaoling can show how findings were logged and resolved, ensuring the team remains compliant with regulatory standards.

Workflow and benefits

By using the Note document type, the team at Stegmann Labs creates a centralized repository of findings and communications. This approach ensures that the team retains critical insights for future reference. It fosters efficient problem-solving and strengthens the team's ability to respond to unexpected challenges during assay development.

In this use case, the Note document reduces the risk of miscommunication, and ensures that regulatory compliance is maintained through thorough documentation and traceability.