Routines
It is 5:45 AM at the Strangnas sterile fill-finish facility in Sweden. The morning shift operator picks up the site-issued tablet, scans the QR code on Filling Line 2, and ProBeya opens the Production Line Startup routine. Step by step, she works through the sequence: scans the equipment barcode to verify identity, confirms utilities are active, verifies line clearance from the previous batch, checks that the batch record is prepared, records the differential pressure reading (17.2 Pa — within the 15-25 Pa range), inspects the first article from the test run, photographs it for the batch record, and digitally signs to confirm completion. The supervisor receives a notification, reviews the results, and countersigns. Total elapsed time: 14 minutes. The line is cleared to start production.
Every step was captured — who did what, when, with what result. The record is timestamped, attributable, and tamper-evident. No paper batch record supplement required.
Why Routines Matter in GxP Environments
In the Toyota Production System, standardized work is the foundation upon which all improvement is built. You cannot improve a process that is not standardized, because you cannot distinguish improvement from random variation.
In pharma manufacturing, this principle carries regulatory weight. ICH Q10 Section 1.3 requires "an effective pharmaceutical quality system to assure... consistent control of manufacturing operations." EU GMP Annex 15 mandates documented verification activities. FDA 21 CFR 211.22 requires "written procedures for production and process control." These are not requests for static documents — they are requirements for documented execution of standardized procedures.
ProBeya's Routine Runner module closes the gap between the SOP (what should happen) and the execution record (what actually happened). It provides three things that paper cannot:
- Consistency: every operator follows the same steps in the same order, every time
- Rich data capture: text, numbers, photos, signatures, barcodes, and checklists — not just checkboxes
- Compliance: supervisor sign-off, audit trail, and certification tracking for GxP environments
Template Authoring
Creating a Routine Template
- Navigate to Routines from the workspace menu
- Click + New Template
- Fill in the template metadata:
| Field | Description | Example |
|---|---|---|
| Name | Human-readable routine name | "Line 2 — Production Startup" |
| Description | Purpose and scope | "Step-by-step startup for sterile filling Line 2" |
| Category | Grouping label | cleaning, inspection, changeover, line_startup, tier1_meeting |
| Estimated Duration | Expected time in minutes | 20 |
| Requires Sign-Off | Whether supervisor must approve | Yes (for GxP-critical routines) |
- Define the steps in order
- Mark critical steps as Required
- Save the template
Step Types
ProBeya supports ten step types that cover the full range of data capture needs in manufacturing:
| Type | Description | Pharma Example |
|---|---|---|
| checklist_item | Binary pass/fail verification | "Safety guards in place" |
| free_text | Open-ended text input | "Describe any anomalies observed" |
| numeric_input | Numeric measurement with optional min/max range | "Record differential pressure (Pa)" with range 15-25 |
| yes_no | Explicit yes/no with follow-up implications | "Emergency stop functional?" |
| photo_capture | Camera/file upload for visual evidence | "Photograph the equipment label" |
| signature | Digital signature for formal acknowledgment | "Operator sign-off" |
| barcode_scan | Equipment or material barcode scanning | "Scan equipment ID" |
| date_input | Date entry for scheduling or recording | "Next calibration due date" |
| info_display | Read-only instruction or guidance text | "Ensure both shift leads are present" |
| kpi_check | Review of KPI data from the board | "Review Safety KPI (last 24h)" |
| action_review | Review of open/overdue actions | "Review overdue actions" |
| value_input | General value entry | "Enter batch number" |
| dropdown | Selection from predefined options | "Select cleaning agent used" |
Steps can be organized into sections using the sectionLabel field for visual grouping, and can carry time limits for time-critical verification activities.
Every step should answer three questions: What must be done? (the label), Why does it matter? (the description), and What does good look like? (the config — min/max for numerics, expected value for text). Steps designed this way reduce operator error and produce data that can be trended over time.
The Pre-Built Template Library
ProBeya ships with six pre-configured routine templates covering the most common pharma manufacturing workflows. These can be imported into any organization and customized.
| Preset | Steps | Duration | Use Case |
|---|---|---|---|
| TIER 1 Daily Meeting | 12 | 15 min | Standard SQCDP review with action management and escalation |
| 5S Workplace Audit | 25 | 45 min | Comprehensive Sort/Set/Shine/Standardize/Sustain audit with photo evidence |
| Gemba Walk | 15 | 30 min | Structured leadership walkthrough: safety, process flow, visual management, team engagement |
| Equipment Pre-Use Check | 10 | 15 min | Visual inspection, calibration verification, functional tests, safety interlocks |
| Production Line Startup | 8 | 20 min | Utilities, line clearance, materials, equipment parameters, first-article, supervisor approval |
| Shift Changeover | 10 | 15 min | Production summary, quality issues, action handover, equipment status, dual sign-off |
Importing a Library Template
- Navigate to Routines → Template Library
- Browse the available presets
- Click Import on the desired template
- Customize the steps, labels, and configuration for your site
- Save as your organization's template
Do not build from scratch. Import the closest library preset, then customize. The TIER 1 Daily Meeting preset, for example, already includes the SQCDP review structure, action management steps, and escalation checkpoint that most pharma sites need. Customization takes 15 minutes. Building from scratch takes hours.
Executing a Routine
Starting an Execution
- Open a routine template
- Click Start Execution
- The routine opens in execution mode with all steps listed
Working Through Steps
For each step:
- Enter the required data (check, text, number, photo, signature, etc.)
- Optionally add notes for context or exception documentation
- The completed at timestamp is automatically recorded when the step is finished
Execution Lifecycle
| Status | Description |
|---|---|
| in_progress | Execution started, steps being completed |
| completed | All required steps finished, results recorded |
| aborted | Execution stopped before completion |
When an execution is completed, the completedAt timestamp is set automatically. If sign-off is required, the supervisor receives a notification and can review the results before countersigning.
Worked Example: Equipment Pre-Use Check
Routine: Equipment Pre-Use Check for Filling Machine FM-204
| Step | Type | Operator Entry | Notes |
|---|---|---|---|
| Equipment ID Scan | barcode_scan | FM-204-SN-00847 | Barcode verified |
| Equipment clean and free of residue | checklist_item | Pass | — |
| No visible damage or wear | checklist_item | Pass | — |
| Equipment condition photo | photo_capture | [Photo uploaded] | Minor scratch on housing — cosmetic only |
| Calibration sticker current? | yes_no | Yes | — |
| Next calibration due date | date_input | 2026-08-15 | 4 months remaining |
| Safety guards in place | checklist_item | Pass | — |
| Emergency stop functional? | yes_no | Yes | Tested — immediate halt confirmed |
| Equipment fit for use? | yes_no | Yes | — |
| Operator sign-off | signature | [Digital signature] | — |
Result: Equipment FM-204 cleared for use. Record stored with full step-by-step evidence, operator identity, and timestamps. Supervisor signs off within 10 minutes.
Scheduling
Routine templates can be scheduled for automatic creation of instances at defined intervals:
| Schedule Parameter | Description |
|---|---|
| Frequency | daily, weekly, monthly, or custom cron |
| Time | When the routine should be started |
| Assigned To | Users or roles responsible for execution |
| Active | Whether the schedule is currently enabled |
Scheduled routines appear in the operator's task list at the configured time, ensuring that recurring verification activities are never forgotten.
Operator Certification
For GxP-critical routines, ProBeya tracks operator certification:
- After an operator completes a defined number of successful executions (configurable threshold) with a quality score of ≥80%, they are automatically awarded a certification for that routine
- Certifications have an expiry date and can be revoked by supervisors
- The certification record includes: who is certified, for which routine, awarded date, expiry date, and the execution history that qualified them
This supports EU GMP Chapter 2.8 ("Personnel... should receive training appropriate to the duties assigned to them") and FDA 21 CFR 211.25 ("adequate training, including current good manufacturing practice training").
Use the certification system to build a competency matrix. When a new operator joins the team, assign them to execute key routines under supervision. Once they meet the certification threshold, the system automatically records their qualification. During an inspection, you can demonstrate that every operator performing a GxP-critical activity has been trained, assessed, and certified — with objective, data-driven evidence.
Analytics
The Routines module provides seven analytics procedures for continuous improvement:
| Analytics View | What It Shows |
|---|---|
| Completion Rate | % of scheduled routines completed on time vs. expected |
| Average Duration | Mean execution time by template — identifies where operators are struggling |
| Step-Level Pass Rate | Per-step compliance rate — surfaces the steps that fail most often |
| Operator Performance | Execution speed and quality by operator — identifies training needs |
| Trend Analysis | Time-series view of completion and quality metrics |
| Overdue Instances | Routines that were started but not completed |
| Certification Status | Active, expiring, and expired certifications by operator |
The Step-Level Pass Rate analytics view is where you find your improvement opportunities. If Step 4 ("Calibration sticker current?") fails 15% of the time across all equipment pre-use checks, you do not have an operator problem — you have a calibration scheduling problem. The routine execution data becomes an input to your continuous improvement cycle.
Integration with ProBeya Ecosystem
Routines connect to the broader platform:
- KPI Boards: Routine completion rates and scores feed directly into SQCDP KPIs
- Action Log: Failed steps or aborted routines can generate tracked actions with one click
- Link Hub: Attach QR codes to equipment for tap-to-start routine execution — scan the code on the filling machine and the Equipment Pre-Use Check opens automatically
- Spatial Digital Twin: Anchor routines to specific locations on floor plans for location-aware execution
- TIER Meetings: The TIER 1 Daily Meeting preset structures the daily standup as a routine itself
Regulatory Context
Routine execution records in ProBeya support compliance with:
- EU GMP Annex 11 Section 7.1: Electronic records of GMP-relevant activities
- 21 CFR Part 11: Electronic records with attributable, timestamped entries and electronic signatures
- EU GMP Chapter 4.29: "Batch processing records should be kept for at least one year after the expiry date of the finished product batch"
- ICH Q10 Section 3.2.2: Monitoring of process performance through standardized verification
- EU GMP Chapter 2.8: Training records demonstrating operator competency (via certification)
The combination of step-by-step data capture, digital signatures, supervisor sign-off, and immutable audit trail creates electronic records that meet ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Permissions
| Action | Required Role |
|---|---|
| Execute routines and view results | Workspace member |
| Create, edit, and delete templates | Workspace admin |
| Sign off on completed executions | Supervisor |
| Manage certifications | Workspace admin |
| View analytics | Workspace member |
| Import library templates | Workspace admin |
| Full access across workspaces | Organization admin |
Related Features
- Standard Work Checklists — Simpler checklist feature for basic verification tasks
- Link Hub — Attach QR codes to equipment for tap-to-start routine execution
- Spatial Digital Twin — Anchor routines to specific floor plan locations
- Gemba Walk — The Gemba Walk routine preset provides a structured leadership walk
- Shift Handover — The Shift Changeover preset structures handover communication