|Ability to search, view and report on master data based on tags/labels
|Support the upgrade of all configured information and maintain data integrity when updating or upgrading application software versions.
|Ability to monitor and control data exchange on all interfaces with message and error logging.
|Data from integrations is historized, stored for use in trending and analysis
|App has to display the time elapsed since starting a process step
|Ability to add equipment context to historize time series data
|Ability to define and maintain batch record documentation for regulatory compliance (electronic batch record)
|Provide the ability to print the material history record
|Ability to scan and read auto-id codes generated or used by other other systems and capture their data into the material history record.
|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
|Ability for Apps to record completion of a process step with all related information
|Track process execution of the Production Models by Apps
|All material tracking history will include context of the operator performing the activities
|All material tracking history will include context of equipment used in processing
|All material tracking history will include date and time stamps
|All tracked information and logs will be available as part of material and process history records.
|Ability to track material attributes during production operations with associated capabilities to browse their history and their trending e.g. temperature, assays, etc.
|Ability to query history records by any related dimension. Ie. equipment, user, work order, material, time, duration, etc.
|All records shall be Contemporaneous. Data captured should include the date and time of the activity/action
|All records shall be Original; all originally recorded data shall be maintained.
|All records shall be Complete. Records shall include all data related to activity with no deletion or overwriting.
|All records shall be Enduring, ie. store, managed and unalterable for the full retention period.
|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.
|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.
|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.
|Ability to manage an authorized change of Digital History Record with full audit trail
|Equipment & cleaning log - The system must be able to create logs for registration of use, maintenance, calibration & cleaning of equipment and rooms.