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Quality and Process

Quality and Process

 

The number of drug targets and potential therapies has grown dramatically. These advances will yield therapies that are targeted to specific sub-populations. 

The net result is that more therapies must be tested more efficiently.

Firms are required to manage to achieve quality goals, and to control processes to produce results in a consistent manner.

Information systems are integral to achieving these goals. Systems must have intelligent features, while meeting regulatory requirements and external data standards. 

...AXON assists clients in improving processes across the development cycle.

Systems must be properly validated as electronic record systems (21CFR11), will increasingly use common data models (CDISC), permit publication of submissions in standard formats (e-Sub PDFs, eCTD), and in some cases must protect patient privacy (HIPAA).

 

Sarbanes-Oxley (SOX) and risk-based approaches are now added to this list of concerns.

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