User Requirements
This page provides a listing of regulated requirements that were utilized to build the Tulip product.
The user requirements on this tab are organized into two categories: ALCOA and ERES and have the following fields:
ID: The ID provides a unique reference to the requirement. The format was changed to ABC-1234 in LTS7 to directly link the numbering from the tickets used internally for development. The prior ID was maintained as a cross reference since LTS7.
Requirement: A brief description that describes the user requirement.
Implemented By: The Product Spec(s) that provide the feature/functionality to support the user requirement. Features may be used individually or in combination with other features to achieve/meet the requirements.
GxP
ALCOA
| ID | Requirement | Implemented By |
|---|---|---|
| PLAT-8734 (852) | System must provide accurate time server synchronization and shall utilize the same time source. | |
| PLAT-8865 (800) | All records shall be Contemporaneous. Data captured should include the date and time of the activity/action. | |
| PLAT-8867 (801) | All records, including audit trail shall be Legible, ie. shall be human readable throughout the retention period. | |
| PLAT-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. | |
| PLAT-8915 (804) | All records shall be Complete. Records shall include all data related to activity with no deletion or overwriting. | |
| PLAT-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. | |
| PLAT-8920 (802) | All records shall be Original; all originally recorded data shall be maintained. | |
| PLAT-8946 (806) | All records shall be Enduring, ie. stored, managed, accessible and unalterable for the full retention period. | |
| PLAT-8948 (805) | All records shall be Consistent, ie capture and recorded in the same manner and in the correct sequence of the acitivities or action being recroded. |
ER ES
| ID | Requirement | Implemented By |
|---|---|---|
| PLAT-8807 (32) | All Users have to be uniquely identified. | |
| PLAT-8809 (29) | Access and use of system and its components shall be limited to authorized users. | |
| PLAT-8829 (26) | Ability to authenticate all defined users with a unique username and password using a single sign-on (eg. oAuth, LDAP, Active Directory, etc). | |
| PLAT-8859 (121) | Ability to define procedural sequences with relevant process information that can guide an operator through task execution. | |
| PLAT-8866 (33) | Display the current user logged in during any interaction with the system. | |
| PLAT-8869 (856) | Continuous signing sessions require two signature components for first signing but only one (secret) component for subsequent signings. | |
| PLAT-8871 (855) | For records supporting batch release it should be possible to generate printouts indicating if any of the data has been changed since the original entry. | |
| PLAT-8872 (830) | All data changes must be captured in audit trail. Audit trail can be turned off or on for GxP needs. This may only be performed by an administrator; it cannot be performed by a user executing an APP. | |
| PLAT-8874 (848) | The ability to discern invalid or altered records. Ability to annotate data is changed. For GMP or critical data changes annotation can be configured as required. | |
| PLAT-8883 (814) | Ability to view, display and and print accurate and complete records, including any attachments, electronic signatures and their associated audit trails. | |
| PLAT-8888 (811) | All records, electronic signatures, and audit trails must be human readable and protected to ensure they are readily retrievable throughout a pre-defined retention period. | |
| PLAT-8891 (816) | The manifestation of an electronic signature should contain the user's full name, date & time, meaning of signature human readable format; the record itself should contain these elements. | |
| PLAT-8893 (815) | Provide an unalterable and enduring link between records and their associated electronic signatures; they cannot be removed, changed, copied, transferred or deleted. | |
| PLAT-8899 (43) | All user maintenance activities shall be recorded. | |
| PLAT-8902 (817) | Ability to require multiple electronic signatures for a record. Ie co-signer, verifier, etc. | |
| PLAT-8904 (820) | Electronic signatures have to be secured and not allowed to be falsified. They can only be used by their genuine owners. | |
| PLAT-8905 (819) | All electronic signatures have authenticate the signatoree 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. | |
| PLAT-8906 (818) | If more than one signature is required the electronic signature shall capture the role of each signatoree. Eg. trainer, verifier, co-signer, etc. | |
| PLAT-8937 (808) | All records have to include the date, time, action or activity, user, and reason for change if applicable. | |
| PLAT-8939 (35) | Automatic logout user from system after a configurable amount of inactivity time. |