International Pharmaceutical

GAMP 5 - Good Automated Manufacturing Practice

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GAMP 5 provides a risk-based framework for validating computerized systems in pharmaceutical and related industries. ATEK's environmental monitoring platform is designed with GAMP 5 principles, providing the validation documentation needed for GxP environments.

Authority: International Society for Pharmaceutical Engineering (ISPE)

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Why Choose ATEK for GAMP 5 Compliance

Pre-Built Validation Packages

Ready-to-use IQ/OQ/PQ documentation reduces validation time and effort.

Risk-Based Approach

Validation documentation scaled appropriately to system risk and your specific use case.

Data Integrity Built-In

ALCOA+ principles embedded in platform design ensure audit-ready data.

Supplier Qualification

Comprehensive supplier documentation supports your vendor qualification process.

GAMP 5 Requirements

Key compliance requirements and how ATEK addresses each one.

Requirement Description ATEK Solution
risk-based
Risk-Based Approach
 Validation effort should be commensurate with the risk and complexity of the system.
Risk-Appropriate Validation
ATEK provides validation documentation packages scaled to system risk, from basic IQ/OQ to comprehensive protocols.
software-categories
Software Categories
 Systems are categorized (1-5) based on complexity and configuration requirements.
Category 4 Configured Product
ATEK's platform is a Category 4 configured product with documented configuration and validation support.
validation-lifecycle
Validation Lifecycle
 Computerized systems must be validated throughout their lifecycle.
Ongoing Validation Support
Release notes, change documentation, and revalidation guidance provided with each platform update.
documentation
Documentation Requirements
 Appropriate documentation must be maintained based on system category and risk.
Comprehensive Documentation
IQ/OQ/PQ protocols, user requirements specifications, and functional specifications available.
change-control
Change Control
 Changes to validated systems must be managed through formal change control.
Change Documentation
All platform changes are documented with impact assessment and validation recommendations.
data-integrity
Data Integrity
 Systems must maintain data integrity throughout the data lifecycle.
ALCOA+ Compliance
Data is Attributable, Legible, Contemporaneous, Original, and Accurate with complete audit trails.
supplier-assessment
Supplier Assessment
 Suppliers of computerized systems should be assessed for quality and capability.
Supplier Qualification Support
ATEK provides quality documentation, SOC 2 aligned security documentation, and audit support for supplier qualification.

Understanding GAMP 5

GAMP 5 (Good Automated Manufacturing Practice Guide, Version 5) was published by ISPE in 2008 and remains the industry standard for computerized system validation in pharmaceutical and related regulated industries. The guide provides a risk-based approach that scales validation effort to system complexity and impact.

Risk-Based Validation

GAMP 5’s fundamental principle is that validation effort should be proportionate to risk:

  • Higher risk systems require more extensive validation
  • Lower risk systems can use streamlined approaches
  • Risk assessment guides validation strategy

Software Categories

The guide defines categories that help determine validation requirements:

Category Description Validation Approach
1 Infrastructure Software Verification of installation
3 Non-Configured Products Configuration documentation
4 Configured Products Configuration and testing
5 Custom Applications Full SDLC documentation

ATEK as Category 4

ATEK’s environmental monitoring platform is a Category 4 Configured Product:

  • Commercial off-the-shelf software
  • Configured to customer requirements
  • No custom code development
  • Validation through configuration documentation and testing

How ATEK Supports GAMP 5 Compliance

ATEK provides the documentation and features needed for validated environments.

Validation Documentation

Our validation packages include:

  • User Requirements Specification (URS): Template for documenting your requirements
  • Installation Qualification (IQ): Verify correct installation
  • Operational Qualification (OQ): Verify system operates as specified
  • Performance Qualification (PQ): Verify system performs in your environment
  • Traceability Matrix: Link requirements to testing

Data Integrity

ALCOA+ principles are embedded in our platform:

  • Attributable: All data linked to user accounts
  • Legible: Clear, readable data presentation
  • Contemporaneous: Real-time data capture
  • Original: First-capture data storage
  • Accurate: Calibrated sensors, validated calculations
  • Complete: No gaps in monitoring records
  • Consistent: Standardized data formats
  • Enduring: Long-term data retention
  • Available: Data accessible when needed

Related Solutions

Explore ATEK monitoring solutions for GAMP 5 compliance.

Biotech & Pharma

GxP-compliant monitoring for pharmaceutical manufacturing.

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Cleanroom Monitoring

Differential pressure and environmental monitoring for cleanrooms.

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Medical Devices

Environmental monitoring for medical device storage.

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GAMP 5 FAQs

What is GAMP 5?

GAMP 5 (Good Automated Manufacturing Practice Guide, Version 5) is a guidance document published by ISPE that provides a risk-based approach to validating computerized systems in pharmaceutical and related industries. It's widely accepted by regulatory agencies including FDA and EMA.

What are GAMP software categories?

GAMP 5 defines five software categories: Category 1 (Infrastructure Software), Category 3 (Non-Configured Products), Category 4 (Configured Products), and Category 5 (Custom Applications). Each category has different validation requirements based on risk and complexity.

What GAMP category is ATEK's platform?

ATEK's environmental monitoring platform is classified as Category 4 - Configured Product. This means it's a commercial product that is configured for your specific use but not custom developed. We provide validation documentation appropriate for Category 4 systems.

What validation documents does ATEK provide?

ATEK provides comprehensive validation packages including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, as well as user requirements specifications and functional specifications.

How does ATEK support data integrity requirements?

ATEK's platform is designed with ALCOA+ principles: data is Attributable (linked to users), Legible (clearly readable), Contemporaneous (recorded when generated), Original (first recording), and Accurate (error-free). Complete audit trails ensure data integrity.

Do I need to revalidate when ATEK updates the platform?

ATEK provides release notes and change impact assessments with each update. Minor updates typically don't require revalidation. Major updates include guidance on revalidation requirements and updated documentation.

Need Help with GAMP 5 Compliance?

Our team of compliance experts can help you implement monitoring solutions that meet GAMP 5 requirements. Contact us for a consultation or demo.

Customized compliance assessment for your facility

Validation documentation packages (IQ/OQ/PQ)

Expert support for audits and inspections

Speak with a Compliance Expert

Our team is available to discuss your specific GAMP 5 compliance requirements.

compliance@atek.io

Get in Touch

Related Regulations

Canada

GUI-0050 Annex 11

Health Canada's GUI-0050 Annex 11 provides detailed guidance on the application of Good Manufacturing Practices (GMP) to computerized systems used in pharmaceutical, radiopharmaceutical, biological, and veterinary manufacturing. This guidance was adopted from PIC/S PE-009-15 Annex 11: Computerised Systems, ensuring that Canadian manufacturers meet internationally recognized standards for data integrity, security, and system validation. ATEK's environmental monitoring platform is designed to help organizations achieve and maintain compliance with these comprehensive requirements.
United States

21 CFR Part 11

FDA 21 CFR Part 11 establishes the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures. ATEK's environmental monitoring platform is designed from the ground up to help organizations achieve and maintain compliance with these critical regulations.
Canada

GUI-0066 Annex 7

Health Canada's GUI-0066 Annex 7 establishes Good Manufacturing Practice (GMP) guidelines specifically for selected non-prescription drugs in Canada that bear a Drug Identification Number (DIN) and appear on the List of Non-Prescription Drugs Not Subject to Certain Testing Requirements. Covering product categories such as toothpastes, mouthwashes, sunscreens, antiperspirants, throat lozenges, anti-dandruff products, acne treatment products, athlete's foot treatment products, diaper rash treatment products, antiseptic skin cleansers, and medicated skin care products, this annex provides modified interpretations of the parent guide GUI-0001. ATEK's environmental monitoring platform provides the technical infrastructure necessary to achieve and maintain compliance with these GMP requirements through continuous monitoring, automated documentation, and comprehensive data management.
Canada

GUI-0069

Health Canada GUI-0069 provides environmental control guidelines for the storage and transportation of pharmaceutical products in Canada. These guidelines establish the requirements for monitoring, controlling, and documenting environmental conditions including temperature and humidity to ensure product quality, safety, and efficacy throughout the supply chain. ATEK's environmental monitoring platform is specifically designed to meet or exceed these guidelines through continuous monitoring, automated compliance documentation, and comprehensive data management.
Canada

GUI-0119

Health Canada's GMP Guidelines for Sterile Drug Products establishes comprehensive requirements for the manufacture of sterile pharmaceutical products. These guidelines ensure that sterile drugs are produced in a controlled manner to minimize contamination risks and maintain product quality and safety. The guidelines cover facility design, environmental monitoring, personnel controls, and manufacturing processes specific to sterile product production. ATEK's environmental monitoring platform is designed to support organizations in maintaining compliance with these critical requirements through continuous monitoring, documentation, and reporting of environmental conditions.
International

ISO 14644-1:2015

ISO 14644-1:2015 is the international standard for the classification of air cleanliness in cleanrooms and associated controlled environments. It establishes classification levels (ISO Class 1-9) based on airborne particle concentration, defines classification procedures using light scattering airborne particle counters, and specifies sampling and statistical methods for verification. ATEK's environmental monitoring platform provides comprehensive support for continuous compliance with ISO 14644-1, integrating particle counting data, environmental parameters, and automated documentation to maintain cleanroom integrity and regulatory compliance.

Ready to Simplify GAMP 5 Compliance?

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