Does the system adhere to the May 2007 Guidance from the FDA on Computerized Systems used in Clinical Investigations (available at http://www.fda.gov/cder/guidance/7359fnl.htm)?
Yes, BIGR® fully supports the May 2007 Guidance from the FDA on Computerized Systems used in Clinical Investigations via the following mechanisms: individual user accounts, recording unauthorized login attempts, locking a user account after an administrator-defined number of failed login attempts, password expiration after an administrator-defined number of days, strong passwords consisting of a combination of numbers and letters, an explicit logoff mechanism, expiration of a user’s session with automatic logoff after an administrator defined period of inactivity, audit trails and time synchronization with time servers.
Related Questions
- Does the system adhere to the May 2007 Guidance from the FDA on Computerized Systems used in Clinical Investigations (available at http://www.fda.gov/cder/guidance/7359fnl.htm)?
- Do the proposed rule and draft guidance apply to PET dugs used in clinical investigations and basic research?
- Does the final rule apply to PET dugs used in clinical investigations and non-clinical research?
