Data interchange

SPC on manufactured products SQC on laboratory operations communicate with corporate CIM system improved QA/QC on products reduced testing costs correlate laboratory analyses and process measurements faster solutions to production problems tested in laboratory faster notification of backlog problems improved electronic data interchange capabiUties automated communication with inventory, ordering, and materials planning systems... 

Is Electronic Data Interchange (EDI) available for inventory transactions with ABC Co. ... 

Data interchange - accepting and returning data via various file transfer mechanisms. 

Clinical Data Interchange Standards Consortium (CDISC)... 

The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit group that defines clinical data standards for the pharmaceutical industry. CDISC has developed numerous data models that you should familiarize yourself with. Four of these models are of particular importance to you ... 

The Clinical Data Interchange Standards Consortium (CDISC) and its Submission Data Standards group have provided another way to broadly categorize clinical trial data. 

Operational Data Model (ODM) for clinical data interchange... 

Over the past 30 years, business automation systems and plant automation systems have developed along different paths, particularly in the way data are acquired, managed, and stored. Process management and control systems normally use the same databases obtained from various online measurements of the state of the plant. Each level in Figure 16.1 may have its own manually entered database, however, some of which are very large, but web-based data interchange will facilitate standard practices in the future. 

Note for Guidance on the Electronic Data Interchange (EDI) of Individual Case Safety Reports (ICSRS) and Medicinal Product Reports (MPRS) in Pharmacovigilance during the Pre-and Post-Authorisation Phase in the EEA (EMEA/115735/2004) (Eudra Vigilance TIG adopted September 2004)... 

Instrument interface for data interchange. -Computational support. 

D3] Cambier, Jim, Biometric Data Interchange Formats—Part 6 Iris image data, ... 

Public Meeting on Clinical Data Interchange Standard Consortium Version 3 Submission Data Standards and Electronic Case Report Tabulations, October 2, 2003, Rockville, MD (Posted October 7, 2003)... 

Currently, most INDs are submitted in paper form, often accompanied by an electronic disk with hyperlinks. Purely electronic submissions are still rare, in large part because of a lack of standardization and electronic sophistication on the part of the FDA. There is currently a Clinical Data Interchange Standards Consortium (CDISC) test underway assuming it proves successful, it is likely that CD ISC will emerge as a common electronic submission standard for INDs, New Drug Applications (NDAs), and Abbreviated New Drug Applications (ANDAs) over the next three to five years. 

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