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✓ FDA 21 CFR Part 11
✓ ICH E6 (R3)
✓ EU Annex 11
✓ ISO 9001
✓ ISO 13485

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FDA Regulations ▼
21 CFR Part 11 - Electronic Records
21 CFR Part 820 - Quality System
21 CFR Part 58 - GLP
21 CFR Part 210/211 - GMP
ICH Guidelines ▼
ICH E6 (R3) - GCP
ICH Q7 - GMP for APIs
ICH Q9 - Quality Risk Management
EU Regulations ▼
EU Annex 11 - Computerized Systems
EU MDR 2017/745
GDPR - Data Protection
ISO Standards ▼
ISO 9001 - Quality Management
ISO 13485 - Medical Devices
ISO 14971 - Risk Management
RQ
Welcome to RegulatoryIQ! I'm your AI compliance assistant with access to over 500+ regulatory documents. Select a regulation from the dropdowns above or ask me any question about regulatory compliance. Try the suggestions below!
We're implementing a new LIMS system for our pharma lab. What are the key validation requirements?
RQ
For a LIMS system in a pharmaceutical laboratory, you'll need to follow a comprehensive validation approach. Here's your roadmap: Risk Assessment (GAMP 5): Your LIMS is likely Category 4 (configured software), requiring full validation. Key Validation Deliverables: 1. User Requirements Specification (URS) • Sample management workflows • Result entry and calculations • Audit trail requirements per 21 CFR Part 11 • Integration with instruments • Reporting capabilities 2. Validation Plan • Define scope (which modules/functions) • Identify critical vs non-critical features • Test strategy based on risk 3. IQ/OQ/PQ Protocols: • IQ: Server specs, software version, user access setup • OQ: Each configured workflow, calculations, reports • PQ: End-to-end business processes with real samples Critical Part 11 Requirements: ✓ Unique user logins (no shared passwords) ✓ Electronic signatures for result approval ✓ Audit trail capturing all data changes ✓ Periodic review procedures Data Integrity Focus Areas: • Define "raw data" for your lab • Backup and recovery procedures • Archive and retrieval process • Review trail for critical decisions 📋 Key Regulations: 21 CFR Part 11, EU Annex 11, FDA Data Integrity Guidance, USP <1058> Would you like me to create a validation timeline or focus on a specific area?
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Part 11 checklist
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E-Signatures Requirements
ALCOA+ Principles
CSV Validation
EU MDR Tech Docs
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Interactive Gap Assessment

Electronic Records (21 CFR Part 11)

60%

Data Integrity (ALCOA+)

80%

Quality Management System

40%

Clinical Trial Compliance

60%

Compliance Analysis Report

Generated: Real-time Analysis

92%

Overall Compliance Score

Based on FDA, ICH, EU MDR Requirements

✅ Electronic Signature Implementation

21 CFR Part 11.50 - 11.200

Compliant

System meets all requirements for electronic signatures including unique identification, two-factor authentication, and non-repudiation controls. Audit trail captures all signature events.

⚠️ Data Integrity Controls

EU Annex 11, Section 7

Minor Gap

Recommend strengthening backup procedures and implementing automated data verification checks. Current manual processes may introduce risks during data migration activities.

❌ System Validation Documentation

21 CFR Part 11.10(a)

Critical Gap

Missing Installation Qualification (IQ) and Performance Qualification (PQ) documentation. User Requirements Specification needs updating to reflect current system configuration.

Ready-to-Use SOP Templates

📄 Electronic Records SOP

21 CFR Part 11 compliant template

📊 Data Integrity SOP

ALCOA+ principles implementation

🔍 Audit Trail Review SOP

EU Annex 11 requirements

✅ CSV Protocol Template

Complete validation package

📝 Change Control SOP

ICH Q10 aligned process

🎯 CAPA Management SOP

ISO 13485 compliant

📦 Complete Template Package Benefits:

  • ✓ 50+ ready-to-use regulatory templates
  • ✓ Fully customizable Word & Excel formats
  • ✓ Pre-filled with regulatory citations
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  • ✓ Includes implementation guides
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Our AI is trained on thousands of regulatory documents and provides accurate compliance assessments with specific citations.

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Template Packages

Ready-to-Use Compliance Templates

Professional templates developed by regulatory experts. Download instantly and customize for your organization.

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21 CFR Part 11 Complete Package

Everything you need for Part 11 compliance

$ 299

One-time purchase

  • ✓ Electronic Records SOP Template
  • ✓ Electronic Signature SOP Template
  • ✓ System Validation Protocol
  • ✓ Audit Trail Review Checklist
  • ✓ User Access Control Matrix
  • ✓ Training Records Template
  • ✓ Risk Assessment Template

Instant download • Word & PDF formats

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Complete Gap Assessment Toolkit

Comprehensive compliance assessment tools

$ 499

One-time purchase

  • ✓ FDA 21 CFR Part 11 Gap Checklist
  • ✓ EU Annex 11 Gap Checklist
  • ✓ ICH E6 (R3) Assessment Tool
  • ✓ Data Integrity Assessment
  • ✓ CSV Assessment Template
  • ✓ Remediation Plan Template
  • ✓ Executive Summary Template
  • ✓ BONUS: 1hr Consultation Call

Most popular • Instant download • Excel & Word formats

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GxP SOP Bundle

Essential SOPs for GxP compliance

$ 399

One-time purchase

  • ✓ Document Control SOP
  • ✓ Change Control SOP
  • ✓ Training Management SOP
  • ✓ CAPA Management SOP
  • ✓ Internal Audit SOP
  • ✓ Deviation Management SOP
  • ✓ Vendor Management SOP

Instant download • Fully customizable

Individual Template Packs

CSV Package

$199

Computer System Validation templates including URS, IQ, OQ, PQ protocols

Clinical Trial Pack

$249

Essential clinical trial documents including protocol template, ICF, monitoring plan

EU MDR Package

$349

EU MDR compliance templates including technical documentation, clinical evaluation

ISO 9001 Kit

$269

Complete ISO 9001:2015 quality management system documentation and procedures

ISO 13485 Kit

$299

Medical device QMS documentation with quality manual and procedures

Data Integrity Pack

$179

ALCOA+ compliance tools, data integrity SOPs, and audit checklists

Audit Prep Bundle

$229

FDA inspection readiness checklist, mock audit templates, response templates

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