What is Computer System:

Computerized systems are the system which used extensively to create, capture, analyze, and maintain electronic record, report information and to control equipment and processes in life sciences industry.

According to American National Standards Institute (ANSI) defines systems as “people, machines, and methods organized to accomplish a set of specific functions.”

Computer or related systems can refer to computer hardware, software, peripheral devices, networks, cloud infrastructure, personnel, and associated documents.

Such computer systems must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

Computerized System Access and Security (level of access, roles & responsibility)

Any computer system that is used in a Regulatory environment must have a secure user log on and password to prevent unauthorized use.

Full use should be made of access controls to ensure that people have access only to functionality that is appropriate for their job role and that actions are attributable to a specific individual.

Companies must be able to demonstrate the access levels granted to individual staff members and ensure that historical information regarding user access level is available. Controls should be applied at both the operating system and application levels.

The system administrator role, including any rights to alter files and settings, should be assigned to personnel independent from those responsible for the record content.

Shared logins or Generic user access should not be used. Where the computerized system design supports individual user access, this function must be used. This may require the purchase of additional licenses.Shared, read-only user accounts that do not allow the user to modify data or settings are acceptable for viewing data.

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