21 CFR Part 11 Compliance

Overview

21 CFR Part 11 establishes requirements for electronic records and electronic signatures when they are used in place of paper records and handwritten signatures in FDA-regulated activities.

Mediature GxP Solutions Pvt. Ltd. (MGS) supports pharmaceutical, biopharmaceutical, API, medical-device, laboratory, pharmacovigilance, and other regulated organizations with Part 11 assessments, gap analysis, remediation planning, validation support, procedural controls, and lifecycle compliance.

Our approach evaluates both technical controls and procedural controls, helping clients ensure that electronic records are trustworthy, reliable, secure, attributable, and appropriately protected throughout their lifecycle.

Our 21 CFR Part 11 Compliance Services

Part 11 Gap Assessment

Assessment of computerized systems and associated procedures against applicable electronic-record and electronic-signature requirements.

Electronic Record Controls

Review of controls related to creation, modification, review, approval, storage, retrieval, retention, and protection of electronic records.

Electronic Signature Controls

Assessment of electronic-signature functionality, identity controls, signature manifestation, authorization, and linkage to associated electronic records.

User Access & Security Review

Evaluation of authentication, user roles, privileges, account management, password controls, and unauthorized-access prevention.

Audit Trail Assessment

Review of audit-trail functionality, configuration, retention, review practices, and ability to reconstruct significant system activities.

System Validation Support

Support for demonstrating that computerized systems perform as intended and reliably execute required GxP functions.

Procedural Control Review

Assessment or development of SOPs governing system administration, user management, electronic signatures, audit trails, backup, recovery, incident handling, and change control.

Gap Remediation Support

Development and implementation support for corrective actions addressing identified technical or procedural compliance gaps.

Periodic Compliance Review

Support for periodic assessment of continued compliance following system changes, upgrades, vendor updates, or evolving business use.

Key Part 11 Areas We Assess

Depending on the system and intended use, MGS may review:

• System validation
• Record accuracy
• Record completeness
• Record retrieval
• Record retention
• Protection of electronic records
• User authentication
• Role-based access
• Authority checks
• Operational checks
• Device checks
• Audit trails
• Electronic signatures
• Signature manifestation
• Signature-to-record linkage
• Password management
• User-account lifecycle
• Backup and recovery
• Data archival
• Change control
• Incident management
• System documentation
• Training
• Procedural controls

Technical & Procedural Controls

Part 11 compliance requires more than software functionality alone.

MGS evaluates the interaction between:

Technical Controls

• Access restrictions
• Authentication
• Audit trails
• Electronic signatures
• Security settings
• Data retention
• Backup
• System configuration
• Record retrieval

Procedural Controls

• SOPs
• User-account management
• Audit-trail review
• Electronic-signature governance
• Change management
• Incident handling
• Backup and recovery procedures
• Periodic review
• Training
• Record retention

Our Approach

• Define Scope

Identify systems, electronic records, electronic signatures, business processes, and applicable regulatory use.

• Assess

Evaluate existing technical and procedural controls against applicable Part 11 requirements.

• Identify Gaps

Document weaknesses in system functionality, configuration, procedures, governance, or validation.

• Prioritize

Classify gaps according to risk to data integrity, product quality, patient safety, and regulatory compliance.

• Remediate

Support implementation of technical, procedural, validation, or governance improvements.

• Verify & Maintain

Confirm corrective actions and support continued compliance through change control, periodic review, and lifecycle management.

Deliverables

Depending on scope, MGS can provide:

• 21 CFR Part 11 assessment
• Gap-analysis report
• Compliance checklist
• System risk assessment
• Remediation plan
• SOP recommendations
• Validation-documentation support
• Audit-trail assessment
• Access-control assessment
• Electronic-signature assessment
• CAPA support
• Periodic-review support
• Compliance-status tracker

Why Choose MGS

Technical & Quality Perspective

MGS evaluates both computerized-system functionality and the quality procedures required to control its use.

Risk-Based Assessment

Compliance gaps are prioritized based on their potential impact on GxP records, quality, safety, and data integrity.

Practical Remediation

Recommendations are designed to be technically realistic and compatible with actual system operation.

CSV Integration

Part 11 requirements can be integrated with broader Computer System Validation and lifecycle activities.

Data-Integrity Focus

Our approach considers how electronic records are created, modified, reviewed, approved, retained, and protected.

Who We Support

MGS can provide 21 CFR Part 11 compliance support for:

• Pharmaceutical manufacturers
• API manufacturers
• Biopharmaceutical organizations
• Medical-device companies
• Laboratories
• CROs
• Pharmacovigilance organizations
• Contract manufacturers
• Quality departments
• IT and digital teams
• Organizations implementing new GxP software
• Sites undergoing system remediation or regulatory inspection readiness