Under this sub section they have mentioned how to control the information getting generated throughcomputer systems/softwares (LIMS) and how to protect, restrict the access to the information that is getting generated.
Now my question is Normal system locks and password protection will be sufficient to control, protect and restrict the access?? or should we implement much more integrated and advanced systems for the control of data and management of information??
Can we adopt the USFDA 21 CFR part 11: Electronic records and electronic signatures requirements and computer system validation?? Is Computer system validation required ??
Now my question is Normal system locks and password protection will be sufficient to control, protect and restrict the access?? or should we implement much more integrated and advanced systems for the control of data and management of information??
Can we adopt the USFDA 21 CFR part 11: Electronic records and electronic signatures requirements and computer system validation?? Is Computer system validation required ??