Complete reference for all 12 Clarix batch step types — what each one does, when to use it, and what the technician sees during execution.

Step Types

Clarix Master Formulas are built from 12 step types. Each type is designed for a specific kind of production activity — from reading an instruction to recording a weight to requiring a co-signature. This page describes every step type in detail.

Step types are configured by the pharmacist or QA officer when authoring or editing a Master Formula. During batch execution, technicians interact with each step according to its type.

1. Instruction

What it is: A read-only text step. The technician must acknowledge reading it before proceeding. No measurement or data entry is required.

When to use it:

Safety warnings before entering a critical area or starting a hazardous process
References to SOPs or equipment procedures (e.g., "Follow SOP-042 for hood cleaning")
General guidance the technician must read before the next step

What the technician sees during execution: The step text is displayed in full. A single Acknowledge button marks the step complete and records the acknowledgement with the technician's identity and timestamp.

Example: "Wear PPE: gloves, mask, gown, and goggles before entering the ISO 5 cleanroom. Verify hood is clean and certified."

2. Measurement

What it is: The technician records a numeric value. An optional target and tolerance can be configured so the system shows a live pass/fail indicator as the value is entered.

When to use it:

Weighing an API or excipient
Measuring pH, osmolality, or conductivity
Recording a temperature or pressure reading
Any numeric measurement where acceptance criteria exist

What the technician sees during execution: A numeric input field with the unit of measure. If a target and tolerance are set, the field shows a live indicator — a green checkmark ✓ if within range, a red ✗ if out of range. The step cannot be completed with a passing acknowledgement if the value is out of tolerance, though the technician can record the value and flag it as a deviation.

Example: Weigh Famotidine USP — Target: 3,648 mg ± 50 mg. Enter actual weight below.

3. Data Entry

What it is: Captures structured data in one of several formats. Unlike Measurement (which is always numeric), Data Entry supports multiple data types depending on what is being recorded.

Available data types:

Weight — numeric with unit (g, mg, kg)
Temperature — numeric with °C or °F
Lot number — text field for recording a material lot
Date — date picker
Time — time picker
Free text — open text for notes, observations, or descriptions
Yes / No — simple binary answer

When to use it:

Recording ambient temperature before mixing
Logging a lot number for an excipient
Capturing the start time of a sterilization cycle
Any structured data point that is not a pass/fail measurement

What the technician sees during execution: An input matched to the configured data type — a number field for weight/temperature, a date picker for dates, a text area for free text, or a toggle for yes/no.

Example: Record ambient temperature in the compounding room before mixing begins.

4. Barcode Scan

What it is: Requires the technician to scan a barcode or QR code before the step is complete. An optional regex pattern validates the scanned value against an expected format.

When to use it:

Confirming the correct raw material container is being used
Verifying the NDC barcode on a drug product
Scanning a vial or container label to confirm lot traceability
Any step where physical confirmation of an item's identity is required

What the technician sees during execution: A scan prompt with two options:

Camera scan — uses the device's camera (on iPad or mobile) to scan a barcode or QR code
USB scanner input — for facilities using a connected USB barcode scanner at a workstation

If a validation regex pattern is configured, the system evaluates the scanned value against the pattern immediately. A matching scan shows a green confirmation; a mismatch shows an error and does not complete the step.

Example: Scan the NDC barcode on the Famotidine USP container. Expected format: 12-digit NDC.

5. Checklist

What it is: A list of individual items that must each be checked off separately before the step is considered complete. The technician cannot simply acknowledge the entire checklist at once.

When to use it:

Pre-batch safety checks (PPE verification, hood status)
Equipment setup confirmation (items on checklist must all be present)
Post-cleaning verification lists
Any multi-item confirmation where each item must be individually verified

What the technician sees during execution: Each checklist item is displayed as a separate row with a checkbox. The technician checks each item individually. Only after all items are checked can they click Complete step. The system records which items were checked and when.

Example checklist:

☐ Gloves worn

☐ Gown worn

☐ Mask worn

☐ Goggles worn

☐ ISO 5 hood cleaning verified

6. Verification

What it is: A second qualified person must independently co-sign the step. This is separate from the primary technician's signature and ensures dual-person verification for critical operations.

When to use it:

Independent weight verification (a second person re-checks a weighed quantity)
Dual-person check for high-potency APIs
Second pharmacist review of a compounding step
Any step where regulatory requirements mandate a second signature

What the technician sees during execution: After the primary technician completes the step, a Request verification prompt appears. A second qualified user must sign in (with their own credentials or PIN) to co-sign. The identities of both the primary technician and the verifying person are recorded in the batch record.

Note: The verifying person must have appropriate permissions to sign off on verifications. Your Admin can configure which roles are permitted to verify.

7. Calculation

What it is: Automatically computes a value using a formula expression that references batch variables and prior step values. The result is calculated by the system and saved to the batch record — no manual entry is required for the computed result.

When to use it:

Calculating adjusted API quantity based on lot purity (e.g., targetWeight / purity)
Computing batch yield
Deriving a dilution volume from batch size and concentration
Any value that should be derived mathematically from other recorded values

Available batch variables in calculation expressions:

Variable	Description
`batchSize`	The batch size entered when the batch was created
`purity`	COA assay % of the issued API lot (as a decimal, e.g., 0.972 for 97.2%)
`targetWeight`	Target weight for the component from the BOM
`step[N].value`	The recorded value from step number N

What the technician sees during execution: The calculation runs automatically when the step is reached. The technician sees the computed result (e.g., Adjusted Famotidine weight: 3,757 mg) along with the expression used. They click Confirm result to accept and record it.

Example expression: targetWeight / purity → calculates the actual weight needed to compensate for lot purity below 100%.

8. Timer

What it is: Starts a countdown timer. The technician cannot mark the step complete until the timer has fully expired.

When to use it:

Mixing time requirements (e.g., mix for 15 minutes at ≥ 250 RPM)
Sterilization cycle hold times
UV exposure times
Any step with a minimum time that must elapse before proceeding

What the technician sees during execution: A countdown display showing the configured duration. The technician clicks Start timer to begin the countdown. The Complete step button is locked until the timer reaches zero. If the page is closed or the app is backgrounded, the timer continues running. The actual start and end times are recorded in the batch record.

Example: Mix Famotidine solution for 15:00 minutes at ≥ 250 RPM before proceeding to filtration.

9. Signature / RPh Gate

What it is: Requires an electronic signature from a user with a specific role (e.g., PIC, QA Officer) before execution can continue past this step. This is sometimes called an "RPh gate" because it is commonly used to require a Registered Pharmacist signature at a critical decision point.

When to use it:

PIC approval before aseptic fill begins
Pharmacist sign-off after sterility testing is complete
QA gate before labeling starts
Any step requiring a specific role's authorization as a hard stop

What the technician sees during execution: The step is locked with a message indicating which role is required (e.g., "Requires Pharmacist-in-Charge signature"). The technician contacts the required person, who enters their credentials directly in the app to electronically sign and release the gate.

The signature is recorded with the signer's user ID, role, timestamp, and IP address for 21 CFR Part 11 compliance.

Role required: The specific role configured in the formula step — the system enforces that only users with that role can sign.

10. Supply Gathering

What it is: Instructs the technician to collect and stage the supplies listed in the step before proceeding. The step requires only an acknowledgement — there is no measurement or scan.

When to use it:

Staging supplies before entering a cleanroom (to minimize traffic)
Gathering filling equipment, vials, and closures before aseptic fill
Preparing labels and packaging materials before labeling
Any pre-phase setup step where the pharmacist wants to ensure readiness is confirmed

What the technician sees during execution: A list of supplies to collect, as configured in the formula. Each supply item is displayed. The technician reviews the list, physically gathers the items, then clicks Acknowledge — supplies gathered to complete the step. The acknowledgement is recorded with identity and timestamp.

Example supply list: Sterile 50 mL syringes (x20), Famotidine 20 mg/mL vials (x500), Aluminum crimp seals, Labels for LOT-2026-0001

11. Label Verification

What it is: The technician confirms that the label applied to a container or package matches the expected information before proceeding. This is a manual visual check, not a barcode scan.

When to use it:

Confirming the correct label is on a vial before filling
Verifying the lot number and expiry printed on a finished container
Confirming product name and concentration on labeled units before release
Post-labeling spot checks

What the technician sees during execution: The expected label information is displayed (product name, lot number, concentration, expiry date). The technician physically inspects the container label and confirms it matches. They click Confirm — label verified and the step is recorded with their identity and a timestamp.

Example: Confirm the lot number on the vial label matches the batch record: LOT-2026-0001. Expiry: 2026-09-01.

12. Photo Capture

What it is: Requires a photograph to be taken and attached to the batch record as documentation.

Note: The Photo Capture step type is visible in the formula builder and batch record but the camera interface is currently marked Coming Soon in the application. Photo documentation can be attached manually to the batch record as a workaround.

When to use it (planned):

Photographing the filling setup before aseptic fill
Capturing evidence of container integrity
Documenting environmental conditions at the start of a run
Any step where a visual record of a physical setup or condition is required

What the technician sees during execution: A camera prompt to take a photo using the device camera. The captured image is attached to the step record with a timestamp and the technician's identity. (Currently shows as Coming Soon — use the batch document attachment feature as an interim.)

Executing Steps — How to work through steps in a batch
Creating a Batch — Opening a new batch against a formula
Worksheets — Companion records completed alongside steps

Step Types

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