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Enforcement, Not Reporting

A Contractor Can't Enter a Cleanroom if Their Gowning Certification Is Expired.

That's not a report. That's enforcement. In pharma, where 21 CFR Part 11 compliance is non-negotiable and FDA auditors demand traceability, disconnected systems from Veeva, SAP, and spreadsheets create gaps. VETTED is the only platform where contractor qualification, training, and safety operations are connected and enforced.

GxP Compliance Dashboard All Systems Compliant
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21 CFR Part 11
Electronic records & signatures
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Audit Trail Complete
All changes logged with timestamps
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Access Controls Active
Role-based permissions enforced
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Training Current
GMP training 100% complete
100%
Audit Trail Compliance
21 CFR
Part 11 Ready
50+
Pharma Clients
Zero
FDA 483s Related to Safety Records

The Enforcement Gap in Pharma

Your ERP tracks batches. Your QMS manages deviations. But who enforces that the maintenance contractor entering your cleanroom has current gowning certification and hazardous materials training? That gap is where compliance failures and incidents happen.

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GxP Documentation

Every safety record must meet GMP, GLP, and GDP requirements. Paper systems and disconnected tools make audit preparation a nightmare.

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Change Control

Safety procedures often require formal change control processes. Tracking changes across disconnected systems leads to compliance gaps.

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Cleanroom Protocols

Cleanroom entry requires specific gowning, training verification, and health screening. Manual processes slow production and risk contamination.

Hazardous Materials

Active pharmaceutical ingredients, solvents, and cytotoxic compounds require specialized handling permits and exposure monitoring.

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Training Documentation

GMP training must be documented, tracked, and verified before work begins. Expired training means work stops - or compliance violations.

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Deviation Management

Safety incidents often trigger quality deviations. Disconnected systems mean double-entry, delayed investigations, and missed root causes.

Compliance Enforced at Every Step

VETTED is designed to support the regulatory frameworks pharmaceutical companies operate within. Our platform architecture supports compliance with key regulations and guidelines.

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FDA 21 CFR Part 11

Electronic records and signatures

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EU Annex 11

Computerized systems compliance

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OSHA 29 CFR 1910

General industry safety standards

Process Safety (PSM)

Highly hazardous chemicals

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GMP Training

Current Good Manufacturing Practice

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ICH Guidelines

Quality and safety harmonization

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Data Integrity

ALCOA+ principles

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Validation

GAMP 5 methodology support

Three Pillars -- Connected and Enforced for Pharma

Contractor Qualification & Compliance. Training & Workforce Compliance. Safety Operations. One record from qualification to incident investigation.

GxP Training That Blocks Non-Compliant Work

Training isn't optional in pharma - it's a regulatory requirement. VETTED's LMS tracks GMP, safety, and SOP training with automatic enforcement. Workers can't access permits, enter cleanrooms, or begin tasks until required training is current and documented.

Automatic work blocking for expired training
SOP-specific training assignments
Training matrices by role and area
Audit-ready training records
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Training Compliance
GMP Fundamentals
Completed - Valid until Dec 2025
Cleanroom Gowning SOP
Completed - Valid until Nov 2025
Hazardous Materials Handling
Due in 14 days - Retraining assigned

Complete Audit Trail for Every Action

21 CFR Part 11 requires attributable, legible, contemporaneous, original, and accurate records. VETTED captures every action with timestamps, user IDs, and before/after states. Electronic signatures meet regulatory requirements with validation protocols included.

Time-stamped audit trail on all records
Electronic signatures with meaning
Change reason capture required
Tamper-evident record storage
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Audit Trail
Permit PTW-2024-0847 Approved
J. Martinez | 2024-02-15 09:23:41 UTC
Risk Assessment Modified
S. Chen | 2024-02-15 09:18:22 UTC
Permit PTW-2024-0847 Created
M. Thompson | 2024-02-15 08:45:03 UTC

Safety-Quality Deviation Integration

When safety incidents impact product quality, your deviation system needs to know immediately. VETTED incidents can automatically trigger quality deviations in your QMS, eliminating duplicate entry and ensuring nothing falls through the cracks.

Automatic deviation triggering
Bidirectional QMS integration
Root cause analysis linking
CAPA tracking across systems
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Deviation Link
Safety Incident INC-2024-0312
Chemical spill in production area
→ Quality Deviation DEV-2024-0089
Auto-created, investigation pending
→ CAPA-2024-0045 Assigned
Spill containment procedure update

Pharma Use Cases

See how pharmaceutical companies use VETTED across their operations.

Cleanroom Operations

Manage cleanroom entry requirements, gowning verification, and environmental monitoring. Block entry for workers without current training or health clearance.

Permit to Work Training Inspections

API Manufacturing

Control hazardous work in API production with specialized permits, exposure monitoring, and PPE verification. Link safety controls to batch records.

Permit to Work JSA Incidents

Lab Safety

Track laboratory safety training, chemical inventory, fume hood inspections, and near-miss reporting. Maintain compliance with lab safety standards.

Training Inspections Incidents

Contractor Management

Pre-qualify contractors for pharmaceutical work, verify GMP training, and control site access. Ensure external workers meet your compliance standards.

Vendor Mgmt Training Permits

Equipment Maintenance

Coordinate maintenance activities with production schedules, manage LOTO permits, and ensure safety during equipment interventions in GMP areas.

Permit to Work JSA Projects

EHS Inspections

Conduct GMP area inspections, safety walkthroughs, and environmental monitoring with mobile-friendly checklists. Auto-generate CAPAs from findings.

Inspections Safety Sidekick Hard Hat Buddy

Integrates With Your Pharma Systems

VETTED connects with the enterprise systems pharmaceutical companies already use.

Custom integrations available for ERP, QMS, LIMS, and other enterprise systems. API documentation provided for IT teams.

Pharmaceutical FAQs

Is VETTED validated for GxP use?
VETTED is built to support 21 CFR Part 11 and Annex 11 compliance. We provide validation documentation packages including IQ/OQ protocols, requirements traceability matrices, and configuration specifications. Your validation team validates the system per your procedures - we provide the documentation to support that process.
How does VETTED handle electronic signatures?
Electronic signatures in VETTED include user authentication, signature meaning (approved, reviewed, verified, etc.), timestamp, and are linked to the specific record version. Signatures are non-repudiable and the audit trail captures all signature events. We support both single sign-on and direct authentication methods.
Can VETTED integrate with our QMS?
Yes. VETTED integrates with major quality management systems including TrackWise, Veeva Vault, MasterControl, and others. Safety incidents can automatically create quality deviations, and CAPAs can be tracked bidirectionally. We also provide a comprehensive API for custom integrations.
How do you handle data hosting for regulated industries?
VETTED offers SOC 2 Type II certified cloud hosting with options for geographic data residency. For organizations requiring it, we also support on-premises deployment. All environments include comprehensive disaster recovery and business continuity capabilities.
What training documentation does VETTED provide?
Our LMS generates training records that meet GMP requirements including trainee identification, training date, trainer identification (for instructor-led), training content reference, and assessment results. Reports can be exported for regulatory submissions and audits.

Ready for Enforcement, Not Just Reporting?

See how VETTED helps pharmaceutical companies maintain compliance while protecting their workforce.