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riganati.blogspot.com

A Piece of My Mind

A blog about quality, test management, and computerized systems validation.

http://riganati.blogspot.com/

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A Piece of My Mind | riganati.blogspot.com Reviews
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A blog about quality, test management, and computerized systems validation.
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1 by daniel riganati
2 in the toolbox
3 application lead
4 create iq protocol
5 application manager
6 business analyst
7 operations manager
8 quality manager
9 perform vendor audit
10 develop sops
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by daniel riganati,in the toolbox,application lead,create iq protocol,application manager,business analyst,operations manager,quality manager,perform vendor audit,develop sops,develop training materials,technical lead,test analyst,validation lead,blogthis
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A Piece of My Mind | riganati.blogspot.com Reviews

https://riganati.blogspot.com

A blog about quality, test management, and computerized systems validation.

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1

A Piece of My Mind: What is a computerized system?

http://riganati.blogspot.com/2012/06/what-is-computerized-system.html

A Piece of My Mind. An irregular journal of what's on my mind. Friday, June 1, 2012. What is a computerized system? What is a computerized system? How is it different from a computer system? System is a computer system with a purpose. When we talk about a computer system, we are simply referring to the hardware and software that comprise the computer system. But when we talk about a computer ized. System, we are referring to a function (process or operation) integrated. Why is this distinction important?

2

A Piece of My Mind: Cracking the Code: 21 CFR Part 11 Authentication and Authorization

http://riganati.blogspot.com/2012/06/cracking-code-21-cfr-part-11.html

A Piece of My Mind. An irregular journal of what's on my mind. Monday, June 25, 2012. Cracking the Code: 21 CFR Part 11 Authentication and Authorization. Recently, I was asked what are the 21 CFR Part 11 compliance implications with the following scenario:. 21 CFR Part 11: Authentication and Authorization. Concerns identifying the user:. 1110(d) Limiting system access to authorized individuals. 1110(g) Use of authority checks to ensure that only authorized individuals can use the system. The clause in red.

3

A Piece of My Mind: Validation Roles and Responsibilities

http://riganati.blogspot.com/2012/07/validation-roles-and-responsibilities.html

A Piece of My Mind. An irregular journal of what's on my mind. Monday, July 16, 2012. Validation Roles and Responsibilities. Who is responsible for validating a computerized system? Validating a computerized system is not a single event. It involves many activities and deliverables (see my previous post Validation is a Parallel Process, Not a Parallel Universe. The following list is an example drawn from the Validation Plan Template. Example of Validation Roles and Responsibilities. Create System Design ...

4

A Piece of My Mind: Now on Technorati

http://riganati.blogspot.com/2012/07/now-on-technorati.html

A Piece of My Mind. An irregular journal of what's on my mind. Friday, July 6, 2012. Now you can find A Piece of My Mind on Technorati. Posted by Daniel Riganati. Subscribe to: Post Comments (Atom). View my complete profile. I work at the intersection of project and quality management leading the way from good practice to best practices in information systems development and computerized systems validation. Documents, Templates, and More. A Piece of My Mind Toolbox. 21 CFR Part 11. Validation – It&...

5

A Piece of My Mind: June 2012

http://riganati.blogspot.com/2012_06_01_archive.html

A Piece of My Mind. An irregular journal of what's on my mind. Monday, June 25, 2012. Cracking the Code: 21 CFR Part 11 Authentication and Authorization. Recently, I was asked what are the 21 CFR Part 11 compliance implications with the following scenario:. 21 CFR Part 11: Authentication and Authorization. Concerns identifying the user:. 1110(d) Limiting system access to authorized individuals. 1110(g) Use of authority checks to ensure that only authorized individuals can use the system. The clause in red.

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A Piece of My Mind

A Piece of My Mind. An irregular journal of what's on my mind. Monday, July 16, 2012. Validation Roles and Responsibilities. Who is responsible for validating a computerized system? Validating a computerized system is not a single event. It involves many activities and deliverables (see my previous post Validation is a Parallel Process, Not a Parallel Universe. The following list is an example drawn from the Validation Plan Template. Example of Validation Roles and Responsibilities. Create System Design ...

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