Validacions

Validacions, commonly translated as validations in English, refer to the processes and activities used to determine whether a product, system, data set, or procedure conforms to defined requirements and user needs. They are applied across industries and domains to ensure quality, safety, reliability, and compliance.

Data validation is a key area, focusing on ensuring information is accurate, complete, and consistent before it is stored or used. Typical checks include type and range validation, format validation, and consistency rules, often implemented through schemas, validators, and business rules.

Software and system validations aim to prove that a product performs as intended in its real-world context. This usually involves a plan-based lifecycle of testing and evidence gathering, including formal validation plans, traceability, and reproducible results. In regulated sectors such as healthcare, finance, and aviation, validation is closely tied to compliance requirements and may require documentation, audits, and independent review.

Process validation is common in manufacturing and life sciences. It demonstrates that a manufacturing process, when operated within predefined parameters, consistently yields products that meet predefined quality attributes. Activities include installation qualification, operational qualification, performance qualification (IQ/OQ/PQ), and ongoing monitoring.

In practice, validation is distinct from verification: validation asks "are we building the right product?" while verification asks "are we building the product right?" International and industry standards, such as ISO 9001, GMP, and ICH guidelines, provide frameworks for conducting and documenting validations.

This concise overview highlights core concepts and common applications, without prescribing a single universal method, recognizing that the exact approach depends on context, risk, and regulatory requirements.