Validating pharmaceutical systems
Such procedures are developed through the process of validation.
This is to maintain and assure a higher degree of quality of food and drug products.
Qualification includes the following steps: There are instances when it is more expedient and efficient to transfer some tests or inspections from the IQ to the OQ, or from the OQ to the PQ.
This is allowed for in the regulations, provided that a clear and approved justification is documented in the Validation Plan (VP).
In use, several interconnected problems led to several devices giving doses of radiation several thousands of times higher than intended, which resulted in the death of three patients and several more being permanently injured.
The FDA introduced 21 CFR Part 11 for rules on the use of electronic records, electronic signatures (FDA 1997).
The FDA regulation is harmonized with ISO 8494, which treats "verification" and "validation" as separate and distinct terms.
On the other hand, many software engineering journal articles and textbooks use the terms "verification" and "validation" interchangeably, or in some cases refer to software "verification, validation, and testing (VV&T)" as if it is a single concept, with no distinction among the three terms.
The desired results are established in terms of specifications for outcome of the process.
Qualification of systems and equipment is therefore a part of the process of validation.
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages.