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Download a Insight 21CFR part 11 requires that all systems that govern any c GXP process - including Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs), should be validated.

FDA issued a very comprehensive guidance on systems validation.

Therefore, it is of utmost importance that a well-organized approach to system validation projects be in place to ensure that An effective strategy is necessary to develop, verify, install, and maintain computerized systems.

Validation is a complex, time-consuming procedure involving different qualifications of equipment used in drug development and manufacturing quality control.

In order to comply with c GMP, companies are required to record, track, manage, store and easily access various production documents and their detailed change history including Standard Operating Procedures (SOPs), Master Production Batch Record (MPBR), Production Batch Record (PBR), Equipment log books etc.

Historically, all such documents have been maintained on paper by companies in order to comply with FDA's c GMP.

After the orders have been sent to your LIS and resulted, run the STS inquiry portion of the test cases.

STS will inquire on the results to capture and document what was received back from the LIS with notifications if tests are still pending in the Atlas system.




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