SDLC Control

IT Systems Validation & Change Control

Presentation Objectives ,[object Object],[object Object],[object Object],[object Object]

Some Background History (Whats been happening ?)

Common themes in all regulations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Common themes in all regulations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Common themes in all regulations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Auditable Quality ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

How is this practical ? The cost of any request for change increases as you near “Go-Live” date. (from Boehm, Barry W. Software Engineering Economics . Englewood Cliffs, NJ: Prentice-Hall, 1981) 0 10 20 30 40 50 60 70 Requirements Design Code Development Testing Acceptance Testing Operation Development Phase Cost/Effort to Correct a Problem

The regulation that best fits. ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

The importance of Computer Systems To the business processes. In the last 20 years, the number of previously manual GxP and business processes now computer controlled has increased dramatically.

What does this mean? ,[object Object]

If we ignore the challenge ? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

The Wrong Approach ,[object Object]

The Correct Approach ,[object Object],[object Object],[object Object]

Where Are We In Relation To This #1 ,[object Object],[object Object],[object Object],[object Object]

Where Are We In Relation To This #2 ,[object Object],[object Object],[object Object]

The Validation Exercise. ,[object Object],[object Object],[object Object],[object Object]

Identifying Risks ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Maintaining The Validated State The Business Environment Changes. You Cannot Assume That Just Because the System Was Validated Last Year That It Is Still In a Validated State… ( A continual process ) Remember, Validation Includes Both System and Process!!!

Maintaining our Validated State ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Maintaining our Validated State ,[object Object],[object Object],[object Object]

Change Control Boards (CCBs) ,[object Object],[object Object],[object Object],[object Object]

Control Board Function ,[object Object],[object Object],[object Object],[object Object]

What are the advantages of a change control board ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Proposal ,[object Object],[object Object],[object Object]

If we ignore the challenge ? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

SDLC Control

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SDLC Control