QA-T377

Verifying Completions

OBJECTIVE
Test the following URS:
  • 800 - All records shall be Contemporaneous. Data captured should include the date and time of the activity/action
  • 801 - All records, including audit trail shall be Legible, ie. shall be human readable throughout the retention period.
  • 802 - All records shall be Original; all originally recorded data shall be maintained.
  • 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.
  • 804 - All records shall be Complete. Records shall include all data related to activity with no deletion or overwriting.
  • 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.
  • 806 - All records shall be Enduring, ie. store, managed and unalterable for the full retention period.
  • 807 - All records shall be Available and can be accessed for review, audit or inspection over the lifetime of the record (retention period).
  • 808 - All records have to include the date, time, action or activity, user, and reason for change if applicable.
  • 809 - All records and electronic signatures have to include an accurate date and time stamp. Date & time stamps shall be configurable with the possibility to include the day, month, year, hour, minutes, seconds and time zone.
  • 810 - Provide managed authorized access to all records and electronic signatures including data, information, configurations, and data files.
  • 811 - All records, electronic signatures, and audit trails must be protected to ensure they are readily retrievable throughout a pre-configured retention period.
  • 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"
  • 815 - Provide an unalterable and enduring link between records and their associated electronic signatures; they cannot be removed, changed, copied, transferred or deleted.
  • 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.
  • 817 - Ability to require multiple electronic signatures for a record. Ie co-signer, verifier, etc.
  • 818 - If more than one signature is required the electronic signature shall capture the role of each signatory. Eg. trainer, verifier, co-signer, etc.
  • 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.
  • 820 - Electronic signatures have to be secured and not allowed to be falsified. They can only be used by their genuine owners.
  • 821 - Ability to define access security levels for records and electronic signatures. Ie. user groups and user roles and their associated privileges to system resources and data
  • 852 - System must provide accurate time server synchronization and shall utilize the same time source.
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