To ensure a smooth and successful compliance process with Scarlet, follow these essential guidelines to submit high-quality regulatory data.
1. Involve your whole team early on
Compliance is not just a task for the regulatory team. Involve your clinical experts, product managers, engineers, and other key stakeholders from the beginning.
Collaborative input ensures that all aspects of your product—from clinical use to technical specifications—are accurately reflected in your compliance data. By doing this, you’ll create a more complete submission that meets regulatory expectations.
2. Write clear, concise descriptions
When preparing data for submission, clarity is key. Imagine you’re explaining your product to someone who understands medicine and software but has no prior knowledge of your specific product. Ask yourself:
“Would someone unfamiliar with my product understand what it does and why it’s important based on the data provided?”
“Can I simplify or shorten my descriptions without losing key information?”
Clear, direct descriptions help assessors understand your product quickly, which speeds up the review process.
3. Use in-line linking to show relationships
To make your data easier to navigate and understand, use in-text linking to show how different pieces of data relate to one another. When referencing other conformers, simply place the conformer name in square brackets [ ]. This helps Scarlet assessors quickly jump between related information, improving the flow of your submission.
This feature - Clinician Portal - takes data from [Feature: Backend processor] and displays patient blood values to [User: Clinician] or [User: Nurse Practitioner]. It also displays the output from [Feature: AI engine] of personalised medication recommendations for each patient. It also lets clinicians send messages to patients via [Feature: patient app].
4. Pay attention to help blocks and work instructions
Scarlet provides helpful hints and examples for each data field to guide you through the submission process. Always refer to these help blocks and follow the work instructions carefully.
This will ensure your data is aligned with regulatory requirements and meets the quality standards that Scarlet expects from your submission.
5. Respond to assessor feedback thoroughly
Throughout the assessment process, Scarlet assessors will provide feedback or request further clarification on certain data points. Take this feedback seriously:
Address every comment or issue raised by modifying conformers or updating data as needed.
Addressed feedback disappears between rounds, so persistent notes indicate areas requiring further attention
6. Ensure your writing is clear and error-free
Poor grammar, unclear sentences, and inconsistent descriptions slow down the assessment process and can lead to delays. To avoid this:
Make sure your descriptions are clear, concise, and free of errors.
Consider using a spell checker within VS Code to catch spelling or grammatical mistakes before submitting.
Accurate and professional writing makes it easier for assessors to understand and evaluate your data, speeding up the overall process.
7. Listen to the problems panel
Use the errors and warnings flagged to guide your work and monitor the ‘completeness’ of your data. The goal is to kill all the problems by adding the required data!
The Problems Panel shows the output of the continuous validation that is automatically running on the data in your repository - it’s useful for identifying missing conformers or pieces of data.