Qualification Focus: Primarily deals with equipment, utilities, and systems. 

Objective: To provide documented evidence that a specific piece of equipment or system is installed correctly, operates as intended, and meets predetermined specifications. 

Process: Involves a series of steps, often referred to as DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification), to confirm that the equipment or system functions as expected in its intended environment. 

Example: Qualifying an autoclave to ensure it consistently reaches the required temperature and pressure for sterilization. 

Validation Focus: Primarily deals with processes and procedures.

Objective: To provide documented evidence that a specific process will consistently produce a product that meets its predetermined specifications and quality attributes.  Process: Involves challenging the process by performing a series of tests and evaluating the results against pre-defined acceptance criteria. Example: Validating a sterilization process to ensure it consistently kills a specified number of microorganisms, using the qualified autoclave.  

Relationship

Qualification is often considered a subset of validation. You typically qualify the equipment or system used in a process before validating the process itself. This ensures that the process is performed using equipment that is fit for purpose and operating correctly.

In Summary

Qualification ensures that equipment and systems are suitable for their intended use. Validation ensures that processes consistently produce the desired quality of product. Both are essential for ensuring product quality and patient safety in regulated industries.

Links to sources for validation of computerized systems

EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines

Annex 11: Computerised Systems

US Food and Drug Administration (FDA)

FDA 21 CFR Part 11