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.The General Principles of Software Validation (FDA 2002) defines verification as "Software verification provides objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements for that phase." It also defines Validation as "Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled".The software validation guideline states: “The software development process should be sufficiently well planned, controlled, and documented to detect and correct unexpected results from software changes." Annex 11 states "The validation documentation and reports should cover the relevant steps of the life cycle." Weichel (2004) recently found that over twenty warning letters issued by the FDA to pharmaceutical companies specifically cited problems in Computer System Validation between 19."Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.Process validation involves a series of activities taking place over the lifecycle of the product and process.".
This is allowed for in the regulations, provided that a clear and approved justification is documented in the Validation Plan (VP).
This combined testing of OQ and PQ phases is sanctioned by the European Commission Enterprise Directorate-General within ‘Annex 15 to the EU Guide to Good Manufacturing Practice guide’ (2001, p.
6) which states that: This requirement has naturally expanded to encompass computer systems used both in the development and production of, and as a part of pharmaceutical products, medical devices, food, blood establishments, tissue establishments, and clinical trials.
This standard was written for a biological manufacturing company and was then written into the PDA's Technical Report # 39,thus establishing the industry standard for cold chain validation.
This was critical for the industry due to the sensitivity of drug substances, biologics and vaccines to various temperature conditions.
Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines.