For newcomers to the pharmaceutical and other FDA-regulated industries, understanding validation processes for automated systems is crucial. This article provides a comprehensive overview of fundamental concepts and standard requirements, essential for ensuring compliance and operational efficiency.

At E2i, drawing from over 40 years of experience supporting clients in pharmaceuticals, life sciences, and food and beverage sectors, we’ve honed our expertise in designing and implementing automated systems subject to FDA oversight. 

Below we outline common acronyms, relevant standards, and typical documentation to facilitate a deeper understanding of validation procedures.

Key Acronyms

Acronyms are pervasive in regulated industries. Here are some frequently used ones:

• CFR: Code of Federal Regulations
• COTS: Commercial off-the-Shelf
• DMS: Document Management System
• FDA: Food and Drug Administration
• FS: Functional Specification
• GAMP: Good Automated Manufacturing Practice
• GDP: Good Documentation Practice
• GMP: Good Manufacturing Practice
• HDS: Hardware Design Specification
• IQ: Installation Qualification
• ISPE: International Society for Pharmaceutical Engineering
• OQ: Operational Qualification
• PQ: Performance Qualification
• QA: Quality Assurance
• RTM: Requirements Traceability Matrix
• SDS: Software Design Specification
• URS: User Requirements Specification

Applicable Standards

Compliance with regulatory guidelines is paramount in FDA-regulated industries. Here are two key standards:

21 CFR Part 11: This FDA regulation focuses on electronic records and signatures, mandating reproducibility and non-modifiability of electronic records. It sets stringent requirements for electronic signatures, emphasizing unique identification traits for each user.

GAMP 5: Developed by ISPE, GAMP 5 offers a risk-based approach to compliant computerized systems. It provides comprehensive guidance on the lifecycle management of automation systems, ensuring adherence to regulatory standards.

Typical Documentation

Documentation is essential for demonstrating compliance and ensuring system integrity. Here are some common types of documentation:

– User Requirements Specification (URS): Captures end-user requirements at a high level, serving as the foundation for subsequent design documentation.

– Functional Specification (FS): Elaborates on URS by detailing system functionalities and configurations.

– Hardware Design Specification (HDS): Documents hardware specifications, including components and part numbers.

– Software Design Specification (SDS): Details software configurations necessary to meet FS requirements.

– Validation Plan: Establishes a testing strategy for validating the system, defining roles and responsibilities.

– Installation Qualification (IQ): Verifies proper installation and configuration of the system according to design documentation.

– Operational Qualification (OQ): Ensures system operation aligns with design specifications, testing functionalities and performance.

– Performance Qualification (PQ): Validates system performance under real-world conditions, confirming operational procedures.

– Summary Reports: Summarize testing results and corrective actions taken, reviewed and approved by end-users.

– Requirements Traceability Matrix (RTM): Correlates system requirements with testing protocols to ensure comprehensive validation.

At E2i, we prioritize adherence to regulatory standards and best practices in validation processes. Our expertise in automation validation ensures clients achieve compliance and operational excellence.

Contact our team to learn more about E2i’s automation validation services.