ABSTRACT
The Scenario. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 473 Developing the Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 475 Maintaining the Validated State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 485 Legacy System Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 485
Electronic Records and Signatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . 486 Specific Validation Work. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 487 The Regulatory Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 488 Moving Forward . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 489 Tackling and Solving Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 489 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 490
THE SCENARIO
As a provider of supply chain services to the pharmaceutical, medical device, consumer (OTC) and hospital services industries, Exel (from now on referred to as the organization) recognizes the requirement to validate systems used to ensure regulatory compliance, a high level of assurance to clients and to continually improve on services provided.
