Worksheets

Worksheets are companion records that are completed alongside (or at the end of) a batch. They capture quality checks and production data that do not fit neatly into individual batch steps. All worksheets become part of the final electronic batch record.

Access worksheets from the Worksheets tab on any batch detail page.

In-Process Controls

In-process controls (IPC) are checks performed at defined points during production — typically at the start and end of compounding — to verify that the product is meeting specifications before proceeding.

What it captures

The In-Process Controls worksheet records:

• Start-of-batch checks — environmental conditions, equipment status, and batch weight at the beginning of compounding
• End-of-batch checks — final measurements, reconciliation weights, and acceptance criteria results

How to complete it

1. Click the In-Process Controls card on the Worksheets tab.
2. The worksheet opens with sections for Start checks and End checks.
3. Work through each field in order, entering the recorded values.
4. Fields with acceptance criteria show a live pass/fail indicator as you type.
5. Sign the worksheet with your electronic signature when complete.
6. A QA Officer countersigns as part of the QA review.

Note: Start-of-batch IPC fields should be completed before execution of critical steps begins. End-of-batch fields should be completed after the final yield is recorded.

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Particle Counts

The Particle Counts worksheet records airborne particulate data for the ISO cleanroom(s) used during compounding. This is required for USP <797> documentation.

How to enter particle count data

Clarix supports three methods for recording particle count data:

Manual entry:

1. Click Particle Counts on the Worksheets tab.
2. Click Add reading.
3. Enter the location (e.g., ISO 5 primary engineering control), particle size (0.5 µm, 5.0 µm), count, and sample time.
4. Repeat for each sample location.
5. Sign when complete.

CSV upload:

1. Prepare your data in CSV format with columns: Location, Date, Time, ≥0.5µm count, ≥5.0µm count.
2. Click Upload CSV on the Particle Counts worksheet.
3. Map your columns to the Clarix fields in the mapping dialog.
4. Review the imported rows and click Confirm import.

PDF upload:

1. If your particle counter exports a PDF report, click Upload PDF.
2. Attach the PDF — it is stored as a supporting document linked to this batch record.
3. Manually enter the summary values for the batch record fields.

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Visual Inspection

The Visual Inspection worksheet documents the inspection of final filled containers for visible particulates, container integrity, clarity, and color.

What it captures

The inspection form records:

• Inspector name and date
• Number of units inspected
• Acceptance criteria — visible particulate-free, clarity, correct fill volume
• Units accepted — count and percentage
• Units rejected — count, and reason for each rejection
• Inspector signature

How to complete it

Role required: Compounding Technician or Lab Technician to perform; QA Officer to countersign.

1. Click Visual Inspection on the Worksheets tab.
2. Enter the number of units submitted for inspection.
3. Work through the inspection criteria checklist — check each criterion that is met.
4. Enter the number of units rejected and document the reason(s) using the rejection codes.
5. Enter the number of units accepted.
6. Sign with your electronic signature.

Rejection codes include: Visible particulate, Container defect, Incorrect fill volume, Stopper/crimp defect, Clarity issue, and Other (requires written description).

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Label Reconciliation

Label reconciliation documents the accountability for every label generated for the batch. Regulators require that you can account for every label — printed, applied, spoiled, or destroyed — to prevent label mix-ups.

What it captures

A discrepancy in label reconciliation (printed ≠ applied + spoiled + destroyed + remaining) is a significant quality event and should be reported as a deviation.

How to complete it

1. Click Label Reconciliation on the Worksheets tab.
2. Enter the quantity of labels printed (from your label print log).
3. Enter labels applied, spoiled, destroyed, and remaining.
4. Clarix automatically calculates the reconciliation and shows Pass or Fail.
5. If the result is Fail, a text field opens to document the explanation.
6. Sign the worksheet.
7. A second signatory (QA Officer or Pharmacist) countersigns to complete the reconciliation.

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Related pages

• Executing Steps — The step-by-step execution workflow
• QA and PIC Release — Worksheets are reviewed as part of QA
• MBR and Exports — All worksheets are included in the PDF batch record