QA-T377

Verifying Completions

OBJECTIVE
Test the following URS:
  • 8859 (121) - Ability to define procedural sequences with relevant process information that can guide an operator through task execution.
  • 8865 (800) - All records shall be Contemporaneous. Data captured should include the date and time of the activity/action
  • 8867 (801) - All records, including audit trail shall be Legible, ie. shall be human readable throughout the retention period.
  • 8920 (802) - All records shall be Original; all originally recorded data shall be maintained.
  • 8916 (803) - All records shall be Accurate. there must be the ability to build accuracy checks into the design of the system or configure verification for manually entered data as necessary.
  • 8915 (804) - All records shall be Complete. Records shall include all data related to activity with no deletion or overwriting.
  • 8948 (805) - All records shall be Consistent, ie capture and recorded in the same manner and in the correct sequence of the activities or action being recorded.
  • 8946 (806) - All records shall be Enduring, ie. store, managed and unalterable for the full retention period.
  • 8937 (808) - All records have to include the date, time, action or activity, user, and reason for change if applicable.
  • 8890 (810) - Provide managed authorized access to all records and electronic signatures including data, information, configurations, and data files.
  • 8888 (811) - All records, electronic signatures, and audit trails must be protected to ensure they are readily retrievable throughout a pre-configured retention period.
  • 8885 (813) - All data shall be Attributable; data must be identified to the person who did the data collection. Records shall include information about how the data was acquired, action/activity performed, where and and when"
  • 8893 (815) - Provide an unalterable and enduring link between records and their associated electronic signatures; they cannot be removed, changed, copied, transferred or deleted.
  • 8891 (816) - When capturing/acquiring an electronic signature the user must be able to see in human readable format the user's full name, date & time, meaning of signature; the record itself should contain these elements.
  • 8902 (817) - Ability to require multiple electronic signatures for a record. Ie co-signer, verifier, etc.
  • 8906 (818) - If more than one signature is required the electronic signature shall capture the role of each signatory. Eg. trainer, verifier, co-signer, etc.
  • 8905 (819) - All electronic signatures have authenticate the signatory by two distinct elements (e.g. username and password; at least one being a private element), or a secure unambiguous biometrics system that cannot be used by anyone other than their genuine owner.
  • 8904 (820) - Electronic signatures have to be secured and not allowed to be falsified. They can only be used by their genuine owners.
  • 8734 (852) - System must provide accurate time server synchronization and shall utilize the same time source.
  • 8869 (856) - Continuous signing sessions require two signature components for first signing but only one (secret) component for subsequent signings
PRECONDITION
The app "Verifying Completions" has already been created: https://qa.tulip.co/process/Lwbsg7cyYfcHanP8P/steps

The user has access to multiple credentials for the instance. The instance is setup as an LDAP instance.

Covers

urs