Frequently Asked Questions

We ship a complete validation package including:

• IQ/OQ script sets
• Comprehensive test harness
• Full trace matrix
• Risk assessment documentation

Your team performs the Performance Qualification (PQ) on your specific environment. Our validation approach is designed to satisfy the most stringent regulatory requirements with minimal effort from your team.

Yes, our Enterprise tier offers a containerized LLM solution that can be deployed on-premises. This includes:

• GPU-optimized container for maximum performance
• CPU fallback option for organizations without dedicated GPUs
• Air-gapped deployment option for highly secure environments
• Regular model updates via secure package delivery

For organizations with strict data residency requirements, this solution ensures all data processing occurs within your controlled environment.

FieldGuardian™ is fully compliant with both EU Annex 11 and FDA 21 CFR Part 11 requirements. All logged entries are:

• Time-stamped with non-modifiable timestamps
• Versioned with complete history
• Reviewable through the management dashboard
• Secured with role-based access controls
• Protected with audit trails for all system interactions

Our solution is designed as a GAMP 5 Category 1 system (Non-configurable), making validation straightforward for regulated environments.

The setup process is remarkably fast:

• 90 seconds to install the extension via the Chrome Web Store
• Approximately 20 minutes to upload your SOP ZIP files to the management dashboard
• Optional 30-minute training session for end users

Most organizations can be fully operational within a single business day, with no IT department involvement required due to our zero-integration approach.

FieldGuardian™ works with any web-based system, including but not limited to:

• ServiceNow
• Veeva QualityDocs
• Oracle SCM
• TrackWise
• MasterControl
• Custom or homegrown LIMS and QMS systems

Our combination of DOM analysis and OCR technology ensures compatibility with virtually any browser-based form system, regardless of its underlying technology or age.

Our extension uses a multi-layered approach to identify compliance-related form fields:

1. DOM Analysis: First, we scan the Document Object Model for text areas and input fields with labels suggestive of quality documentation (e.g., "Root Cause," "Corrective Action," etc.).
2. Pattern Recognition: We identify common form patterns used in ServiceNow, Veeva, and other QMS systems.
3. OCR Fallback: For legacy systems or unusual interfaces, we use optical character recognition to identify form fields visually.

This approach ensures reliable field detection across a wide range of platforms without requiring custom configuration.

We implement industry-leading security measures:

• Client-Side Encryption: All text is encrypted with WebCrypto API before transmission.
• PII Detection: Automatic identification and masking of personally identifiable information.
• No Data Retention: All analysis payloads are purged within 10 seconds of processing.
• "No Training" Flag: We use OpenAI's "no training" policy to ensure your data never contributes to model training.
• SOC 2 Type II Compliance: Our infrastructure and processes are independently verified.

For Enterprise customers, our on-premises solution offers complete data isolation within your own environment.

Training requirements are minimal:

• A 30-minute introduction session is typically sufficient for end users.
• We provide an optional 60-minute advanced session for managers who will be reviewing and overriding suggestions.
• Training materials including videos, quick reference guides, and full documentation are provided.

Most users find the system intuitive and require little formal training to become productive.

SOP updates are flexible and can be handled in several ways:

• Manual uploads through the management dashboard whenever SOPs change
• Optional scheduled updates (weekly, monthly, or quarterly)
• Enterprise customers can set up automatic synchronization with their document management system

All SOP changes are versioned with complete history, ensuring traceability between compliance suggestions and the specific SOP versions they reference.

We offer tiered support options based on your plan:

• Pilot: Email support during business hours with 24-hour response time
• Growth: Priority email and chat support with 4-hour response time
• Enterprise: 24/7 dedicated support with 1-hour SLA, including phone support and named Technical Account Manager

All customers have access to our comprehensive knowledge base, community forums, and regular webinars on compliance best practices.