Suppose Autoclve set parameters enter wronge date so i can cut the wrong date put Wright date on electric data with entry errow or wrong date entry and sign and date of correction it’s possible in electronic data record?
This is a Data integrity issue and indicates absolute negligence and carelessness of the Autoclave operator and other concerned persons. If it is one time error then its Ok. If this is repeatative error then it reflects on poor data integrity practices in the organization.
However please ensure following documentation,
You can do manual correction in the date and sign the corrected date. Write reason for correction with date on which corrction was made.
Prepare CAPA plan and ensure that the concerned operator is trained on Data integrity importance and how to check all entries (whether on paper or electronic document) before excution of Audtoclave operation. There should be double checking system for critical parameters / activities.
Keep all above documentation along with Autoclave data which has been corrected as above.
Follow your internal SOP of Data integrity, Good Documentation practices & CAPA etc.
Any data integrity found take deviation and give proper CAPA?
In fact this is a non-conformance. You may raise deviation as per your internal SOP.
And follow above procedure (CAPA) as I have suggested.
First of all autoclave should not have provision to enter date and time mannually,it should be auto synchronised with satalite clock, if defference between autoclave and satalite clock is more than 2-3 minutes or which is mentioned in your SOP then synchronise with satalite clock first and then proceed further.
If synchronisation skipped then take deviation and CAPA.