IS/ISO/IEC 17025:2017 Clause 7, sub clause 7.11 Control of data and information management

#1
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 ??
 
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#2
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 ??
17025 requires that you perform the normal functions that indicate that you take management of your laboratory data seriously. They do not set a level of protection, like other sections of this document they expect you to take measures as appropriate for your organization. A medical testing lab needs more stringent security than the guy who calibrates surface plates.

You need to validate your LMS. That only makes sense for any organization, to prove that your system works properly. CFR Part 11 requirements can be used here, but for most calibration facilities this might be overkill.

Basically, you need to demonstrate that you have taken appropriate measures to protect your customer's data and their confidentiality. This is all part of managing risk to the customer.
 
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