Safety Database Management

Overview

A pharmacovigilance safety database is the central system used to capture, process, review, maintain, and report Individual Case Safety Reports and other safety information.

Mediature GxP Solutions Pvt. Ltd. (MGS) supports Marketing Authorization Holders, pharmaceutical companies, CROs, and other life-sciences organizations with safety database setup, configuration support, user management, case workflow support, validation activities, data review, reporting outputs, reconciliation, change control, and lifecycle maintenance.

Our approach focuses on data integrity, workflow control, regulatory reporting, user access, auditability, validation, configuration management, and reliable case traceability throughout the database lifecycle.

Our Safety Database Services

Database Setup & Configuration Support

Support for initial database setup, company configuration, product configuration, workflow definition, user-role setup, and business-rule alignment.

Product & License Configuration

Support for creation and maintenance of:

• Product masters
• Active ingredients
• Dosage forms
• Strengths
• Marketed products
• License information
• Country information
• Reference safety information
• Reporting rules

Workflow Configuration Support

Support for defining and reviewing case-processing workflows such as:

• Book-In
• Data Entry
• Quality Review
• Medical Review
• Client / PVOIC Review
• Regulatory Reporting
• Case Lock
• Archival

User Access Management

Support for role-based user access, privilege review, account setup, user modification, access revocation, and periodic access review.

Case Data Management

Support for accurate entry, review, maintenance, and updating of safety information within the database.

MedDRA & Drug Dictionary Management

Support for terminology updates, version upgrades, coding configuration, testing, and implementation.

Reporting Rule Configuration

Support for defining reporting destinations, timelines, seriousness criteria, expectedness rules, and applicable regulatory outputs.

Regulatory Output Generation

Support for generation and verification of safety-reporting outputs such as:

• E2B(R3) XML
• CIOMS I
• Other applicable case-reporting formats

Submission Tracking Support

Support for maintaining submission dates, destinations, acknowledgments, transmission status, and related reporting records.

Reconciliation Support

Support for case and submission reconciliation between the safety database, business partners, source records, and regulatory reporting records.

Database Validation Support

Support for validation planning, requirement review, test-script development, execution, deviation handling, and validation documentation.

Change Control & Upgrade Support

Assessment and controlled implementation of configuration changes, dictionary upgrades, system updates, patches, workflow changes, and new functionality.

Audit Trail & Data Integrity Review

Support for review of database auditability, user activities, data changes, record history, and controls supporting reliable safety data.

Database Archival & Retrieval Support

Support for controlled case closure, archival, retention, and retrieval of safety records in accordance with applicable requirements.

Key Database Areas We Support

Depending on scope, MGS may support:

• Case intake configuration
• Case workflows
• Product configuration
• Study configuration
• Reporter information
• Patient information
• Event data
• Seriousness
• Expectedness
• Listedness
• Causality
• Medical coding
• Follow-up information
• Submission data
• Reporting destinations
• Attachments
• Audit trails
• User roles
• Access controls
• Case locking
• Nullification controls
• Archival
• Reconciliation
• Reporting outputs
• Validation documentation

Key Safety Database Considerations

MGS may assess:

• Intended use
• System validation
• Data integrity
• User access
• Workflow segregation
• Review and approval stages
• Case status visibility
• Audit trails
• Coding dictionaries
• Product masters
• Reporting rules
• Submission tracking
• Acknowledgment handling
• Duplicate management
• Change control
• Backup and recovery
• Data retention
• Archival
• System upgrades
• Business continuity
• Periodic review

Our Approach

• Understand

Review the client’s pharmacovigilance processes, product portfolio, reporting obligations, workflow, users, and system requirements.

• Configure

Support setup of products, workflows, users, reporting rules, dictionaries, and other relevant database parameters.

• Validate

Support risk-based verification of critical database functions, workflows, configurations, and reporting outputs.

• Operate

Support routine case processing, data maintenance, user administration, reporting, and reconciliation activities.

• Monitor

Review database performance, access, changes, submissions, acknowledgments, deviations, and data-quality indicators.

• Maintain

Support dictionary upgrades, configuration changes, periodic review, revalidation, archival, and continued validated-state maintenance.

Typical Deliverables

Depending on scope, MGS can provide:

• Database setup support
• Product configuration records
• User-access matrix
• Workflow configuration documentation
• Reporting-rule configuration support
• Validation Plan
• User Requirement Specification
• Test scripts
• Validation Summary Report
• MedDRA upgrade testing
• Submission tracking records
• Reconciliation logs
• Audit-trail review support
• Change-impact assessments
• Periodic-review documentation
• Database status trackers
• Archival and retrieval support

Why Choose MGS

PV Operations & System Integration

MGS combines pharmacovigilance process knowledge with safety-database and compliance requirements.

Workflow-Focused Configuration

Database workflows can be aligned with defined case-processing, review, approval, reporting, and closure responsibilities.

Data-Integrity Focus

Our approach considers access control, auditability, traceability, data changes, submission records, and record retention.

Validation & Change-Control Support

MGS can support both initial database validation and ongoing lifecycle changes such as upgrades and configuration modifications.

Flexible Support Model

Services can be tailored to database setup, routine administration, validation, reporting, reconciliation, or complete lifecycle support.

Who We Support

MGS can provide Safety Database Management support for:

• Marketing Authorization Holders
• Pharmaceutical companies
• Biopharmaceutical organizations
• CROs
• Generic-drug manufacturers
• Product-license partners
• Organizations implementing new safety databases
• Organizations migrating or upgrading existing PV systems
• Teams requiring database validation or compliance remediation