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CUSTOMISATION OF CATALYST STANDARD WAREHOUSE MANAGEMENT SYSTEM (WMS) PRODUCT – REPORT GENERATION FOR ELI – LILLY. Automated procedures are increasingly
used by companies in all stages of the manufacturing process. As a result,
key decisions and actions are being taken through electronic interfaces
and many records are being generated electronically. Companies in industries
regulated by the United States Food and Drug Administration (FDA), who choose
to use systems which utilize electronic records and electronic signatures
to replace the paper records and handwritten signatures currently required
by FDA regulation, must comply with Title 21 Code of Federal Regulations
(21 CFR Part 11) Electronic Records; Electronic Signatures. 21 CFR Part 11
document outlines specific controls on the use of electronic records and
electronic signatures, because the FDA believes that the risks of falsification,
misinterpretation, and alteration without leaving evidence are higher with
electronic records than with paper records. Role: Designer & Programmer. |