Cleanroom Management

ProBeya Cleanroom Management provides a dedicated configuration and audit subsystem for voice-operated environments in GxP-regulated facilities. It ensures that every voice command executed in a cleanroom is logged, auditable, and compliant with pharmaceutical quality standards.

Overview

Pharma manufacturing cleanrooms impose strict operational constraints: gowning requirements, limited touchpoints, and stringent documentation. Operators in these environments need to interact with ProBeya without touching screens. Cleanroom Management bridges this gap by defining per-location voice configurations and maintaining a full audit trail of every command executed in cleanroom mode.

The feature separates cleanroom configuration (admin CRUD) from cleanroom auditing (compliance logging and export), enabling independent access control and clear separation of concerns.

Getting Started

1. Navigate to cleanroom settings -- Go to Settings > Cleanroom from the workspace sidebar.
2. Create a configuration -- Click "Create Configuration" and fill in the environment details (name, location tag, command set, display mode).
3. Assign a location tag -- If using NFC or BLE beacons, enter the tag identifier so devices auto-activate cleanroom mode when scanned.
4. Configure behavior -- Choose between full or simplified command sets, set auto-logout timeout, and enable continuous listening if appropriate.
5. Deploy devices -- Register cleanroom devices via the Devices tab to monitor session status and connectivity.

Key Concepts

• Cleanroom Configuration -- A named set of behavior rules for a specific physical cleanroom location. Defines command set, display mode, timeouts, and audit requirements.
• Location Tag -- An NFC tag or BLE beacon identifier that triggers automatic cleanroom mode activation when a device enters range.
• Command Set -- Either full (all voice commands available) or simplified (restricted to essential operational commands for high-risk areas).
• Display Mode -- standard or large text mode. Large mode uses bigger fonts for readability through cleanroom visors.
• Continuous Listening -- When enabled, the microphone stays active between commands, eliminating the need for a wake word in hands-free environments.
• Audit Narration -- When requireAuditNarration is enabled, operators must verbally confirm their actions, which are recorded in the audit trail.
• Auto-Logout -- Configurable timeout (in minutes) after which an inactive cleanroom session automatically ends to prevent unauthorized access.

How It Works

Configuration Management

Administrators create one or more cleanroom configurations, each representing a physical cleanroom location. Multiple configurations can share the same location tag (e.g., different configs for day shift vs. night shift). The system supports up to 50 configurations per organization -- typical pharma sites rarely exceed 20 cleanroom environments.

NFC / BLE Auto-Activation

When a device scans an NFC tag or detects a BLE beacon, the client calls getByLocationTag to find matching configurations. If autoActivate is enabled, cleanroom mode starts immediately with the matched config's settings. If multiple configs match, the client selects the appropriate one based on shift or time-of-day rules.

GxP Audit Trail

Every voice command executed during a cleanroom session is logged via the logCommand procedure. Each audit entry records:

• Session ID and user identity
• Raw spoken command text
• Parsed intent and executed procedure
• Command parameters (as JSONB)
• Execution result (success, failure, or cancelled)
• Precise client-side timestamp
• Device ID and location tag

Audit Export

Compliance officers can query the audit log with filters (user, date range, result status) and export the data as CSV for archival or submission to quality management systems. The CSV includes all fields needed for regulatory review.

Audit Summary

Aggregated metrics provide at-a-glance compliance dashboards showing commands per day, success rate per user, and overall result distribution. Server-side aggregation ensures fast performance even for months of audit data.

Configuration

Setting	Description	Options
Name	Friendly name for the cleanroom environment	Free text
Location Tag	NFC/BLE beacon identifier for auto-activation	Free text (optional)
Auto-Activate	Start cleanroom mode automatically when tag detected	On / Off
Command Set	Available voice commands in this cleanroom	full / simplified
Auto-Logout (min)	Idle timeout before automatic session end	1-999 minutes
Display Mode	Text size for cleanroom visor readability	standard / large
Continuous Listening	Keep microphone active between commands	On / Off
Require Audit Narration	Operators must verbally confirm actions	On / Off

Permissions

Role	Access
Organization Owner / Tenant Admin	Full CRUD on configurations, full audit access
Site Admin / Workspace Admin	Full CRUD on configurations, full audit access
Operator	Use cleanroom mode (commands are logged automatically)
Auditor / QA	Read-only access to audit logs and CSV exports

All procedures are organization-scoped. Audit log data never leaks across tenants. Deleting a configuration does not remove associated audit logs -- those remain permanently for compliance.

Tips & Best Practices

Start with simplified command sets

For initial deployment in high-risk cleanrooms, use the simplified command set. This reduces the chance of misinterpreted commands while operators build familiarity. Upgrade to full once success rates stabilize above 90%.

Enable audit narration for critical processes

In GMP-critical areas, enable requireAuditNarration so that every operator action includes a verbal confirmation recorded in the audit trail. This provides an additional layer of documentation for regulatory inspections.

Use auto-logout to prevent session hijacking

Set auto-logout to 5-15 minutes for shared cleanroom terminals. This ensures that if an operator forgets to end their session, the next operator does not inadvertently execute commands under the previous user's identity.

Troubleshooting

Issue	Cause	Solution
NFC tag not activating cleanroom mode	Location tag in config does not match the scanned tag value	Verify the exact tag identifier in the cleanroom configuration
Audit log shows gaps	Client-side logging failed due to network issues	Check device connectivity; audit entries are logged per-command, not batched
CSV export times out	Date range covers too many entries	Narrow the date range; typical exports should cover 1-3 months at a time
"Configuration not found" on delete	Config was already deleted or belongs to another org	Refresh the configuration list and try again
Continuous listening drains battery	Microphone stays active indefinitely	Reduce auto-logout timeout or disable continuous listening for battery-powered devices

FAQ

Can I have multiple cleanroom configs for the same physical room? Yes. Multiple configurations can share the same location tag. This is useful for different shift configurations (day shift with full commands, night shift with simplified commands). The client selects the appropriate config based on context.

Are audit logs deleted when I remove a cleanroom configuration? No. Audit logs are linked to voice sessions, not configurations. Deleting a configuration only stops future auto-activation for that location. All historical audit data remains intact for compliance.

How many cleanroom configurations can I create? There is no hard limit in the API, but the system is designed for typical pharma site scales (1-50 configurations). The list endpoint fetches all configs without pagination, which performs well up to this range.

Related Features

• Voice Analytics -- Usage and adoption metrics for voice commands across the organization
• GxP Compliance -- Broader GxP compliance framework including electronic signatures and audit trails
• AI Intelligence -- AI-powered natural language processing that enhances voice recognition
• KPI Boards -- The operational KPIs that operators update via voice commands in cleanrooms