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1. Introduction
2. Biography
3. History of computers in GLP
4. 4 main topics
5. This presentation
6. GLP (computing) requirements
7. GLP requirements (1)
8. GLP requirements (2)
9. Identification of the user
10. Logging on
11. Provantis top level menu
12. Security
13. User identification
14. Access by function
15. Audit trailing and change control (of data)
16. Raw data request
17. Raw data report
18. Electronic signatures
19. Electronic protocol approval
20. Approving a protocol (1)
21. Approving a protocol (2)
22. What is a session?
23. Signing a session (1)
24. Signing a session (2)
25. Helping to run the studies (1)
26. Helping to run the studies (2)
27. Checking completion (1)
28. Checking completion (2)
29. Checking completion (3)
30. Validation rules - range checking
31. Example of logic checking
32. Reduction in errors (1)
33. Reduction in errors (2)
34. Labelling
35. Software development (1)
36. Software development (2)
37. Software development (3)
38. Operational activities (1)
39. Operational activities (2)
40. Validation (1)
41. Validation (2)
42. Requirements definition
43. Example requirements
44. Configurable
45. Calculated endpoints
46. Summary - 4 main topics

Topics Covered

• History of computers in GLP
• Improvements brought about in efficiency and accuracy in data collection and reporting
• The reasons for using computers in GLP
• The most important aspects of computer systems design and operation with regards to GLP

Links

Series:

• Good Laboratory Practice

Categories:

• Methods
• Pharmaceutical Sciences

Talk Citation

Publication History

• Published on March 1, 2012

Financial Disclosures

• Mr. John McNamee has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.