specs/models/M_APP_VER_COMP
App Version Completion
A completion log is an append-only list of all "completion" events that occured for a given Tulip App. Each completion contains base fields ( Start Time, End Time, Duration, Logged in User, Station Name, Comments, Step Time, Version) as well fields that change from App to App depending on the steps, variables, and records defined for that App.
Fields
Each completion log contains the following fields
| Name | Description |
|---|---|
| Start Time | The time the App began running. |
| End Time | The time when the "Complete" event occured. |
| Duration | The total time between the start and end time. |
| Logged in User | The user that was logged in at the station as the App was running. |
| Station Name | The name of the station where the completion occured at the time it occured. |
| Station ID | The unique ID of the station where the completion occured |
| Comments | Any comments added to the completion. |
| Step Time | How long was spent on each individual step. |
| Step List | A list of all steps and step groups in the app at the time of completion |
| Version | The version of the App for which the completion occured. |
| Variables | The value, at the time of the completion, for each variable in the App. Each value results in a distinct entry in the completion log. |
| Records | The value, at the time of the completion, for each record in the App. Each record results in a distinct entry in the completion log. |
| Application Name | The name of the application at the time that the app was completed |
| Application ID | The unique of the ID of the application where the completion was registered |
| Execution ID | The unique ID of the completion |
| Canceled | Indicates whether the app was "canceled" in other words, halted before completion after being started. If a run of the app is cancesled, it is not considered in Analyses. |
Tests
| ID | Name |
|---|---|
| QA-T100 | Record Placeholders : 06 - Table Data Tab |
| QA-T108 | Signature Step : 03 - Signature form should allow any user to submit it when configured so |
| QA-T109 | Signature Step : 04 - Signature form should allow only the current user to submit it when configured so |
| QA-T110 | Signature Step : 05 - Signature forms should only be submittable a single time per process run |
| QA-T111 | Signature Step : 06 - Signature forms should display the user name and timestamp of submission in data exports |
| QA-T112 | Signature Step : 07 - Signature widgets should accept username and password in LDAP mode |
| QA-T207 | Analytics - Completion Data can be Ignored by Analytics |
| QA-T328 | Apps Page : 06 - App Completions Export Data |
| QA-T389 | Completions - Parallel Players have separate Completions |
Requirements
| ID | Requirement |
|---|---|
| 21 | Ability to search, view and report on master data based on tags/labels |
| 41 | Support the upgrade of all configured information and maintain data integrity when updating or upgrading application software versions. |
| 42 | Ability to monitor and control data exchange on all interfaces with message and error logging. |
| 62 | Data from integrations is historized, stored for use in trending and analysis |
| 72 | App has to display the time elapsed since starting a process step |
| 238 | Ability to add equipment context to historize time series data |
| 248 | Ability to define and maintain batch record documentation for regulatory compliance (electronic batch record) |
| 249 | Provide the ability to print the material history record |
| 259 | Ability to scan and read auto-id codes generated or used by other other systems and capture their data into the material history record. |
| 267 | All process execution activities have to be recorded in history log and include the ID of user that is performing the activity and date-time stamp |
| 292 | Ability for Apps to record completion of a process step with all related information |
| 293 | Track process execution of the Production Models by Apps |
| 348 | All material tracking history will include context of the operator performing the activities |
| 349 | All material tracking history will include context of equipment used in processing |
| 351 | All material tracking history will include date and time stamps |
| 356 | All tracked information and logs will be available as part of material and process history records. |
| 427 | Ability to track material attributes during production operations with associated capabilities to browse their history and their trending e.g. temperature, assays, etc. |
| 465 | Ability to query history records by any related dimension. Ie. equipment, user, work order, material, time, duration, etc. |
| 800 | All records shall be Contemporaneous. Data captured should include the date and time of the activity/action |
| 802 | All records shall be Original; all originally recorded data shall be maintained. |
| 804 | All records shall be Complete. Records shall include all data related to activity with no deletion or overwriting. |
| 806 | All records shall be Enduring, ie. store, managed and unalterable for the full retention period. |
| 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. |
| 827 | Ability to capture data during App execution and identify the data with the version of the App that was used and its status in the workflow. ie. be able to identify if data was generated during App testing, review or approved states. |
| 830 | All data changes must be captured in audit trail. Audit trail can be turned off or on GxP needs. This may only be performed by an administrator; it cannot be performed by a user executing an APP. |
| 831 | Ability to manage an authorized change of Digital History Record with full audit trail |
| 900 | Equipment & cleaning log - The system must be able to create logs for registration of use, maintenance, calibration & cleaning of equipment and rooms. |