To comply with BioTrack Florida’s updated standards and address common integration challenges with QA samples, Canix has implemented new QA Package Guardrails. These updates help ensure smooth operations, reduce errors, and maintain compliance. This guide details the new functionality and how to use it.
Overview of QA Package Guardrails
The QA Package Guardrails introduce new restrictions and guidelines to manage QA samples effectively. These include limits on QA sample creation, adjustments, and usage in workflows. Below are the key updates and their implications.
Key Features of QA Package Guardrails
1. Limit QA Sample Creation
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Restriction: Only one QA sample can be created per source tag.
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How It Works:
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When attempting to create a QA sample from a source package that already has a QA sample, the option is disabled.
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Hover Tip: “Only one QA Sample can be created per package.”
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2. Prevent QA Samples from QA Samples
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Restriction: QA samples cannot be created from other QA samples.
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How It Works:
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If a package is a QA sample, the “Testing Package” checkbox is disabled.
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Hover Tip: “QA Samples cannot be created from QA Samples.”
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3. Restrict Actions on QA Samples
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No Splitting: QA samples cannot be sub-lotted or split into smaller packages.
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Hover Tip: “QA Samples cannot be split.”
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No Combining: QA samples cannot be combined with other packages.
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Hover Tip: “QA Samples cannot be combined.”
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4. Remove QA Samples from Manufacturing Inputs
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Restriction: QA samples cannot be used as inputs for manufacturing runs.
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QA samples are automatically excluded from auto-allocation logic.
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5. Disable Adjustments on QA Samples
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Restriction: Adjustments to QA samples are no longer allowed.
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How It Works:
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The “Adjust Package(s)” action is disabled for QA samples.
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Hover Tip: “QA Samples cannot be adjusted.”
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Benefits of QA Package Guardrails
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Error Reduction: Prevents common workflow issues reported to BioTrack Florida.
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Improved Compliance: Aligns with BioTrack’s standards for QA sample handling.
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Streamlined Processes: Simplifies workflows by eliminating invalid actions on QA samples.
Frequently Asked Questions (FAQs)
1. Why can I only create one QA sample per package?
To comply with BioTrack’s guidelines, each package can have only one QA sample. This prevents duplication and ensures clear tracking of QA processes.
2. Why can’t I split or combine QA samples?
Splitting or combining QA samples could compromise their integrity and tracking. These actions are restricted to maintain compliance and accuracy.
3. Can I adjust QA samples after creation?
No, QA samples cannot be adjusted to ensure their data remains consistent and compliant with regulatory standards.
4. Why don’t QA samples appear in manufacturing runs?
QA samples are not valid inputs for manufacturing processes and are excluded to prevent errors and ensure compliance.
By implementing these guardrails, Canix ensures your workflows remain efficient and compliant with BioTrack Florida’s standards. For additional support, reach out to our team!