Some useful definitions

COMPUTER SYSTEM VALIDATION (CSV) 21 CFR PART 11
1

Biometrics: A method of verifying an individual’s identity based on unique physical feature(s) or repeatable actions.

Closed Systems - A computer environment where access to the system or data is: controlled by persons who are responsible for the content of the electronic record(s) residing on the system.

Digital Signature - An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and parameters allowing for the identity of the signer and the integrity of the data to be established, maintained and verified.

Electronic Record - Any combination of text, graphics, data, audio, video, or otherinformation represented in digital form. This information is created, modified, maintained, archived, retrieved, or distributed by a computer system.

Electronic Signature - A computer data compilation of any symbol or series of symbolsexecuted, adopted or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.

Open System - A computer environment where access to the system or data is not controlled by persons who are responsible for the content of the electronic record(s) residing on the system.

2

what is basic difference between deviation and NC (non conformance).
Nc could be consider as unplanned deviation.

3

Good question and one that seems to always crop up.

First of all a deviation and non conformance are usually always down to human error. I have seen IQ/OQ protocols where there are sections for both Deviations and non-conformances

Deviation:
A deviation typically is documentation, typically in a verification/validation report, explaining why aspects of the verification/validation were changed from what was originally described in the associated protocol, ie why did the executer deviate from the protocol.

Non-conformance:
A non-conformance is a departure of a quality characteristic from its intended level or state that occurs with a severity sufficient to cause an associated product or service not to meet a specification requirement.
or
A departure of a quality characteristic from its intended level or state that occurs with a severity sufficient to cause an associated product or service not to satisfy intended normal or foreseeable usage requirements.

4

If any minor NC happened and it will not affect the product quality, identity or strength. That is to be recorded and cover in CAPA (corrective and preventive action) or fill a unplanned deviation for the same.