Validating edit control
Additional validation procedures also include those that are designed specifically to ensure that modifications made to an existing qualified development flow or verification flow will have the effect of producing a product, service, or system (or portion thereof, or set thereof) that meets the initial design requirements, specifications, and regulations; these validations help to keep the flow qualified.It is a process of establishing evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements.It is a process that is used to evaluate whether a product, service, or system complies with regulations, specifications, or conditions imposed at the start of a development phase.
To solve this kind of difficulties, some regulatory bodies or compendial methods usually provide the advices on what the circumstances or conditions that the performing of a specified system suitability test should be applied and compulsory.
Each template of DQ, IQ, OQ and PQ usually can be found on the internet respectively, whereas the DIY qualifications of machinery/equipment can be assisted either by the vendor's training course materials and tutorials, or by the published guidance books, such as step-by-step series if the acquisition of machinery/equipment is not bundled with on- site qualification services.
This kind of the DIY approach is also applicable to the qualifications of software, computer operating systems and a manufacturing process.
In some contexts, it is required to have written requirements for both as well as formal procedures or protocols for determining compliance.
It is entirely possible that a product passes when verified but fails when validated.