Bioanalysis Zone

Contents

0. Foreword/Introduction – Chad Briscoe, PRA Health Sciences

1. Laboratory informatics for the bioanalytical laboratory– Bob McDowall, R D McDowall Limited

2. Laboratory information management systems (LIMS) for bioanalysis – Bob McDowall, R D McDowall Limited

3. Development of an integrated informatics solution for advanced bioanalytical business analytics – Jan Miotto, Metrendalytics  LLC

4. Electronic notebooks in the bioanalytical lab: a perspective on determining return on investment (ROI) – Joe Rajarao, IDBS

5. Electronic notebooks: the paperless laboratory – Sarah K Peters, Celerion, Inc. and Linda L Sloup, Celerion, Inc.

6. Computerized systems validation – Bob McDowall, R D McDowall Limited

7. Importance and application of electronic standards in bioanalysis – Dana Vanderwall, Bristol-Myers Squibb

8. Automation tools – Ming Li and Judy Chou, Biogen, Inc.

9. The future of big data in regulated bioanalysis: clouds, trends and transparency – Nick Levitt, TwoCenter Technologies

Appendix: Pertinent Regulations and Guidances in Electronic Data Use – Chad Briscoe, PRA Health Sciences

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