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 - LDAP Signature Widgets should accept a correct username/password pair
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
QA-T651	Signature Step : 07 / LDAP Signature Widgets should reject wrong/empty passwords

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.