Validation in regulated industries covers a wide range of disciplines each with its own objectives, documentation requirements, and challenges.
This glossary provides clear explanations of the most commonly used validation terms and their role within regulated environments.
A
Analytical Instrument Validation (AIV)
The verification that analytical instruments and their associated software operate accurately, reliably, and consistently throughout their lifecycle. It includes calibration, qualification, and performance testing to ensure valid results and compliance with regulatory standards.
Annex 11
A European Union guideline outlining the requirements for computer systems used in pharmaceutical and biotech manufacturing. Annex 11 focuses on data integrity, security, and validation of computerized systems.
Audit Trail
A chronological record of all system activities that enables the reconstruction of events. Audit trails are essential for traceability and compliance, documenting who performed an action, when it occurred, and what changes were made.
C
CAPA (Corrective and Preventive Action)
A process used to identify, investigate, and correct non-conformances while preventing their recurrence. CAPA ensures continuous improvement and maintains validated systems in a controlled state.
Cleaning Validation (CV)
The process of demonstrating that cleaning methods effectively remove residues of active ingredients, cleaning agents, and potential contaminants from manufacturing equipment. Cleaning validation prevents cross-contamination and ensures product safety.
Cold Chain Validation (CCV)
The validation of systems and equipment that control temperature-sensitive processes such as storage and transportation. Cold chain validation ensures that conditions remain within defined limits to maintain product quality and stability.
Commissioning and Qualification (C&Q / CQV)
Structured activities performed during the installation or startup of systems, facilities, or equipment. Commissioning confirms proper installation and functionality, while qualification documents that performance meets approved design and quality criteria.
Computer Software Assurance (CSA)
A risk-based approach to software validation promoted by regulatory authorities such as the FDA. CSA focuses on critical thinking, risk assessment, and efficient testing to ensure compliance while reducing unnecessary documentation effort.
Computer System Validation (CSV)
The formal process of testing and documenting that a computer-based system performs as intended in a secure, reliable, and traceable manner. CSV ensures data integrity and compliance in computerized environments.
Continuous Process Verification (CPV)
An ongoing method of monitoring manufacturing process performance and product quality in real time. Continuous verification ensures that critical parameters remain in control and deviations are detected promptly.
D
Data Integrity
The assurance that data is complete, consistent, accurate, and protected from unauthorized alteration. It is a core principle of regulated environments, ensuring that all information remains reliable and verifiable throughout its lifecycle.
E
Electronic Signature
A secure digital authorization that verifies the identity of the signer and confirms the authenticity and integrity of electronic records. Electronic signatures are a key compliance requirement under 21 CFR Part 11 and Annex 11.
Equipment Validation (EV)
A qualification process that verifies equipment design, installation, operation, and performance. It provides documented assurance that equipment functions consistently and within approved specifications.
G
Method Validation (MV)
A structured process used to confirm that analytical or testing methods are scientifically sound, precise, accurate, and suitable for their intended use. Method validation ensures data reliability and regulatory compliance.
P
Periodic Review
A scheduled evaluation of validated systems to confirm continued compliance, performance, and data integrity. Periodic review helps ensure that systems remain aligned with regulatory and operational requirements over time.
Process Validation (PV)
The collection and assessment of data throughout process design, qualification, and production to demonstrate that a manufacturing process can consistently deliver products meeting pre-defined specifications and quality attributes.
R
Retrospective Validation
Validation of a system already in use, performed through the evaluation of historical data, maintenance logs, and performance records. It is often required when compliance gaps are identified or new regulatory expectations are introduced.
Risk-Based Approach
A validation strategy that focuses resources on the functions and processes that pose the greatest potential risk to product quality, patient safety, or data integrity. This approach aligns validation effort with true regulatory and operational priorities.
T
Traceability
The ability to track each requirement, test, change, or deviation throughout the validation lifecycle. Traceability ensures end-to-end visibility and demonstrates compliance during audits or inspections.
U
Utility Validation (UV)
The documented verification of utility systems such as purified water, clean steam, compressed air, process gases, and HVAC. Utility validation ensures that these systems operate reliably within defined parameters and do not compromise product quality or safety.
V
Validation Lifecycle Management (VLM)
A comprehensive approach that integrates all validation activities from requirement definition and risk assessment to testing, deviation handling, and periodic review. VLM ensures that validated systems remain in a state of control throughout their operational life.
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21 CFR Part 11
A U.S. FDA regulation establishing the criteria for electronic records and electronic signatures. It ensures that electronic data and digital approvals are trustworthy, reliable, and equivalent to paper-based documentation.