Hi everyone,
I have a question for you. I have been asked if a written result is always required in the “Result” field in an OQ, (Pharma equipment). My thoughts are that if the acceptance criteria has a range, then a written result is required. If however the acceptance criteria is as simple as “The Light goes on”, a Yes/No or Pass/Fail tick box followed by a “performed by / initial/date” would suffice.
What are your views on this? Is it written anywhere the an actual hand written result is required? Doe this “hand writing” add any value to the result?
As you indicated: For attribute data, such as Yes/No or Pass/Fail, a checkmark is acceptable. For variable data, an actual result must be recorded. An initial/date is required in either case.
As to your question regarding better validity from a handwritten entry: If someone wanted to falsify data, they could just as easily do that with variable data as with attribute data.
The regulatory authorities document what is acceptable and ticks are never acceptable.
If you layout your document to enable ticks to be used then your document is simply none compliant and highlights your ignorance of the regulatory requirements.
The minimum that is acceptable to a regulator is a dated initial and that is only acceptable as long as the full signature along with the sample initial is registered within the document.
Elaborative statements & tick mark both are acceptable. Only thing is that one should wisely draft the protocol where it is required to put elaborative statement & where to tick mark. Approach open & shut question can be reffered for the same.