Computer System Validation:- Computer System Validation (CSV) is often
referred to as software validation. Regulated companies perform validation
projects to prove that their software or system is performing the way it is
supposed to work, and not performing in ways that it isn’t intended to work.
Why Need to Computer
System Validation :- There are several of
examples as to why software validation is important. Look at our library of Warning Letters to see more than 200 reasons to
validate your software or systems. Our Computer
System Validation Boot Camp students
read a case study about Therac-25, a radiation therapy machine from the 1980s.
Due to programming issues, the machine could administer the wrong amount of
radiation to patients (often as a huge overdose), which led to serious injuries
and even death. Had there been software validation standards in place, these
types of instances could have been identified and remediated prior to the
treatment of patients.
Computer system
validation is serious and the FDA and other regulatory agencies do not take
this lightly.
Definition of US FDA Term :- “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” – General Principles of
Software Validation: Final Guidance for Industry and FDA Staff
KEY Point
As Per USFDA Term
“Confirmation by
examination”
– must have defined user needs and intended uses. The user can be a patient,
someone in the hospital, a lab tech, a QA engineer, a manufacturing person.
Examine the software to confirm that it functions as defined in the requirements
and that it will be suitable for its intended use.
“provision of
objective evidence” – there must be defined software
requirements. Document all validation activities and test results.
“user needs and
intended uses” – examine the software to ensure that it meets the user
needs and defined requirements. This could include design reviews, code
reviews, testing, etc. Define what the user needs to do with the software and
how they will use the software.
“particular
requirements implemented through software” – confirm that the
requirements can be consistently fulfilled (not just in a single situation).
This could include stress testing multiple data sets, performance testing with
many users in many locations, testing with multiple browsers or web apps, testing
from multiple devices (and even mobile apps), etc. Define how the software
needs to work to enable the intended use.
“consistently
fulfilled” –
need to have objective evidence of this confirmation (for inspections).
Document all validation activities and test results. The examination needs to
confirm that the software will work in all anticipated situations.
Note :- This is Only Knowledge Purpose and Blog Contain is my View + Internet Search and Guideline.
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