Regulatory Compliance

🎯 Compliance Overview

Masetra is designed from the ground up to meet the stringent regulatory requirements of the pharmaceutical industry. Our platform helps organizations maintain compliance while improving operational efficiency and quality management processes.

⚖️ Key Regulatory Standards

FDA 21 CFR Part 11

Electronic Records and Electronic Signatures

Masetra fully complies with FDA 21 CFR Part 11 requirements for electronic records and signatures:

Electronic Records Requirements

Record Integrity: Immutable audit trails for all system activities
Data Accuracy: Validation of data entry and processing
Record Retention: Configurable retention periods with automated enforcement
Record Accessibility: Easy retrieval and export of records
System Security: Role-based access control and authentication

Electronic Signatures Requirements

Signature Association: Binding signatures to specific records
Signature Verification: Unique user identification and authentication
Signature Intent: Clear indication of signing intent
Signature Linking: Permanent association with signed records
Signature Controls: Secure signature creation and management

Good Manufacturing Practice (GMP)

Pharmaceutical Quality Standards

Masetra supports GMP compliance through:

Quality Management System

Deviation Management: Systematic deviation reporting and investigation
CAPA System: Comprehensive corrective and preventive action management
Change Control: Controlled change management processes
Quality Risk Management: Risk assessment and mitigation tools
Quality Review: Periodic quality system evaluation

Documentation Control

Document Lifecycle: Complete document management from creation to archive
Version Control: Automated versioning and approval workflows
Document Security: Access control and confidentiality protection
Document Retention: Automated retention and disposal schedules

ISO 9001:2015

Quality Management Systems

Masetra supports ISO 9001:2015 compliance through:

Leadership and Commitment

Management Review: Automated reporting for management review meetings
Policy Management: Quality policy deployment and communication
Resource Management: Resource allocation and tracking

Planning and Support

Risk Management: Integrated risk assessment tools
Document Control: Comprehensive document management
Competence Management: Training and competency tracking

Operation and Performance

Process Control: Workflow automation and control
Monitoring and Measurement: Performance metrics and dashboards
Nonconformity Management: Deviation and CAPA management
Continual Improvement: Improvement opportunity identification

ISO 13485:2016

Medical Devices Quality Management

For medical device manufacturers, Masetra supports:

Regulatory Requirements

Design and Development: Design control documentation
Production Control: Manufacturing process control
Supplier Control: Supplier qualification and monitoring
Customer Feedback: Complaint handling and analysis

Product Realization

Planning: Product realization planning
Validation: Process validation documentation
Traceability: Product traceability throughout lifecycle
Sterility: Sterility assurance documentation

🌍 Regional Compliance

East African Community (EAC)

Regional Pharmaceutical Standards

Masetra complies with EAC pharmaceutical regulations:

Uganda National Bureau of Standards (UNBS)

Quality Standards: Compliance with UNBS pharmaceutical standards
Manufacturing Licenses: Support for license application documentation
Product Registration: Product registration support documentation

Kenya Pharmacy and Poisons Board (PPB)

Good Manufacturing Practice: PPB GMP compliance support
Quality Control: Laboratory data management
Pharmacovigilance: Adverse event reporting support

Tanzania Food and Drugs Authority (TFDA)

Manufacturing Standards: TFDA compliance documentation
Quality Assurance: Quality system documentation
Regulatory Reporting: Regulatory submission support

International Standards

WHO Guidelines

Good Manufacturing Practice: WHO GMP compliance
Quality Assurance: WHO quality assurance guidelines
Pharmacovigilance: WHO pharmacovigilance standards

ICH Guidelines

Q7: Active Pharmaceutical Ingredients GMP
Q8: Pharmaceutical Development
Q9: Quality Risk Management
Q10: Pharmaceutical Quality System

🔧 Compliance Features

Audit Trail System

Comprehensive Activity Logging

Audit Trail Components

User Actions: All user activities with timestamps
Data Changes: Before/after values for all modifications
System Events: Automated system activities
Security Events: Login attempts and security events
Approval Actions: All approval and rejection activities

Audit Trail Features

Immutable Records: Non-modifiable audit trail entries
Searchable Logs: Advanced search and filtering
Export Capabilities: Export to regulatory formats
Retention Management: Configurable retention periods
Real-time Monitoring: Live audit trail monitoring

Electronic Signature System

21 CFR Part 11 Compliant Signatures

Signature Types

Digital Signatures: Cryptographically secure signatures
Electronic Signatures: System-generated electronic signatures
Wet Signatures: Scanned physical signature integration
Group Signatures: Role-based signature authority

Signature Controls

User Authentication: Multi-factor authentication
Signature Intent: Clear indication of signing intent
Signature Binding: Permanent association with records
Signature Verification: Signature authenticity verification
Signature Revocation: Signature invalidation when needed

Document Control System

GMP Compliant Documentation

Document Lifecycle

Creation: Document creation with templates
Review: Multi-level review workflows
Approval: Authorized approval processes
Distribution: Controlled document distribution
Retrieval: Easy document search and retrieval
Archive: Automated document archiving

Document Security

Access Control: Role-based document access
Version Control: Automated version management
Change Control: Controlled document changes
Confidentiality: Document confidentiality protection
Integrity: Document integrity verification

Validation Support

Computer System Validation (CSV)

Validation Documentation

User Requirements Specification (URS): System requirements documentation
Functional Specification (FS): Detailed functional specifications
Design Specification (DS): Technical design documentation
Validation Protocol (VP): Testing protocols and procedures
Validation Report (VR): Test results and validation summary

Validation Testing

Installation Qualification (IQ): System installation verification
Operational Qualification (OQ): System operational testing
Performance Qualification (PQ): System performance testing
Regression Testing: Ongoing system validation
Change Control: Validation impact assessment

📊 Compliance Reporting

Standard Reports

Pre-built Regulatory Reports

Quality Reports

Deviation Summary: Monthly deviation statistics
CAPA Effectiveness: CAPA completion and effectiveness
Audit Findings: Audit results and corrective actions
Training Records: Employee training completion
Supplier Performance: Supplier quality performance

Compliance Reports

21 CFR Part 11 Compliance: Electronic record compliance status
GMP Compliance: GMP compliance assessment
ISO Compliance: ISO standard compliance status
Audit Trail Reports: Comprehensive audit trail summaries
Change Control Reports: Change control effectiveness

Custom Reporting

Flexible Reporting Capabilities

Report Builder

Drag-and-Drop Interface: Easy report creation
Data Filtering: Advanced data filtering options
Chart Types: Multiple visualization options
Export Formats: PDF, Excel, CSV export
Scheduled Delivery: Automated report delivery

Regulatory Submission Support

eCTD Format: Electronic Common Technical Document support
FDA Submission: FDA regulatory submission formats
EMA Submission: European regulatory submission formats
WHO Submission: WHO regulatory submission formats
Regional Submission: Regional regulatory submission support

🔒 Data Privacy and Protection

European Data Protection Regulation

Data Subject Rights

Right to Access: Data access request fulfillment
Right to Rectification: Data correction capabilities
Right to Erasure: Data deletion when appropriate
Right to Restrict: Data processing restriction
Right to Portability: Data export in standard formats

Data Protection Measures

Privacy by Design: Built-in privacy protection
Data Minimization: Collection of only necessary data
Purpose Limitation: Data use restriction to stated purposes
Storage Limitation: Automated data retention
Integrity and Confidentiality: Data security measures

Data Sovereignty

Regional Data Residency

Data Location

East Africa Hosting: Data hosted within East Africa
EU Hosting: EU data residency options
US Hosting: US data residency options
Custom Hosting: Client-specific hosting arrangements
Multi-region Support: Global data distribution

📈 Compliance Monitoring

Real-time Compliance Dashboard

Live Compliance Status Monitoring

Key Metrics

Compliance Score: Overall compliance health
Open Items: Outstanding compliance items
Due Dates: Upcoming compliance deadlines
Risk Levels: Current compliance risk assessment
Trend Analysis: Compliance performance trends

Alert System

Due Date Alerts: Upcoming deadline notifications
Non-compliance Alerts: Compliance violation notifications
Risk Alerts: Elevated risk condition notifications
System Alerts: System health and security alerts
Custom Alerts: Organization-specific alert configuration

Automated Compliance Checks

Continuous Compliance Monitoring

Scheduled Checks

Daily Checks: Daily compliance verification
Weekly Reports: Weekly compliance summaries
Monthly Reviews: Monthly compliance assessments
Quarterly Audits: Quarterly compliance audits
Annual Reviews: Annual compliance evaluations

Compliance Rules Engine

Rule Definition: Custom compliance rule creation
Rule Execution: Automated rule evaluation
Violation Detection: Non-compliance identification
Remediation Tracking: Corrective action tracking
Exception Management: Compliance exception handling

📞 Support

For compliance questions, contact info@masetra.com or call +256-760-927180.

Last updated: July 30, 2025