TULIP DOCS (LTS4)User Requirements
This page provides a listing of requirements that were utilized to build the Tulip product. It is organized into the following sections.
| Category | Function |
|---|---|
| GxP | ALCOA |
| ER - ES | |
| Integration | Integration |
| Intelligence | Analytics |
| Reporting | |
| Visualization | |
| Models & Master Data | All Models |
| Equipment Models | |
| Material Models | |
| Production Models | |
| Non-functional | Performance |
| Maintenance | |
| System | |
| Production Management | Preparation & Dispatching |
| Planning | |
| Monitoring & Tracking | |
| Execution | |
| Resource Management | Equipment Control |
| Material Control | |
| User Control |
GxP
ALCOA
| ID | Requirement | Implemented By |
|---|---|---|
| 33 | Display the current user logged in during any interaction with the system. | |
| 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 acitivities or action being recroded. | |
| 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. |
ER - ES
| ID | Requirement | Implemented By |
|---|---|---|
| 19 | Provide the ability to configure an e-signature requirement for any master data definition or model's status transition in the approval workflow | |
| 31 | User record has to include valid full name | |
| 35 | Automatic logout user from system after a configurable amount of inactivity time | |
| 37 | Disable user account when user exceeds the configured number of failed authentication attempts. This applies to all access methods available to any records within the system and during electronic signature authentication. | N/A not supported |
| 43 | All user maintenance activities shall be recorded. | |
| 51 | Content (master data) modifications must be audit trailed. | |
| 111 | Provide managed way to modify equipment model definitions with full audit trail. | |
| 161 | Provide managed way to modify production model definitions with full audit trail. | N/a roadmap |
| 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 | |
| 814 | Ability to view, display and and print accurate and complete records, including any attachments, electronic signatures and their associated audit trails. | |
| 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 signatoree. Eg. trainer, verifier, co-signer, etc. | |
| 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. | |
| 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 priveleges to system resources and data | |
| 822 | Ability to define password policies including rules for password strength, password aging and password repitition. | N/A not supported |
| 823 | Ability to periodically check accounts against configured policy (e.g., password aging). This requirement applies to all access methods available to any records in the system. | N/A not supported |
| 824 | Ability to enforce automatic expiration of passwords by configured policy. This requirement applies to all access methods available to any records in the system. | N/A not supported |
| 825 | All user access to the system shall be tracked. User access activities shall be included in audit trail. Unauthorized access attempts to the system must be recorded. | N/A roadmap |
| 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. | |
| 828 | Only approved connector configuration are available for production execution activities | N/A not supported |
| 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 | |
| 845 | Ability to identify data tables or columns as GxP data | N/A Roadmap |
| 846 | If GxP data is changed after being approved then approval needs to be rejected. Ie batch record needs to be reapproved. | |
| 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. | |
| 849 | Changes to batch record, GMP or critical data should be governed by a global configuration to allow/disallow changes. | N/A Roadmap |
| 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. | |
| 856 | When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual. |
Integration
Integration
| ID | Requirement | Implemented By |
|---|---|---|
| 23 | Ability to use biometric devices for login and authentication. | |
| 26 | Ability to authenticate all defined users with a unique username and password using a single sign-on (eg. oAuth, LDAP, Active Directory, etc). | |
| 57 | Allow integration of simple IIoT end-points for data input and capture | |
| 58 | Allow integration of advanced IIoT end-points for interaction with equipment and collaboration with devices | |
| 59 | Ability to integrate legacy equipment or devices as an IIoT end-point | |
| 62 | Data from integrations is historized, stored for use in trending and analysis | |
| 63 | Data from connected end-points can be sent to other connected end-points | |
| 64 | Data from connected end-points can be sent to connected core systems (MES, QMS, PLM, LIMS, and Sample Inventory) | |
| 65 | Data from connected end-points can be sent to other content | |
| 100 | Ability to retrieve, examine, and view batch/lot and material attributes used in the processing step (e.g. potency), from external source. | |
| 101 | Ability to use a scale and record scale readings like (but not limited to) Zero, Tare, Gross Weight, Net Weight | |
| 149 | Ability to provide access to relevant documents such as SOPs at process step | |
| 234 | Ability to send and receive data from legacy equipment or devices | |
| 236 | Ability to capture time series data from (historize) manufacturing equipment | |
| 238 | Ability to add equipment context to historize time series data | |
| 239 | Ability to capture (historize) alarm and event information from equipment | |
| 242 | Ability to retrieve all historized information for a specific equipment with date-time filters | |
| 342 | Ability to automatically capture data from process equipment in fermentation production | |
| 431 | Ability to automatically submit sample transfer order to external material system. | |
| 433 | Material transfer orders to external system shall contain sample information (ID, name, description) and location information (room, storage equipment, location in equipment). Ie. room name, floor number, freezer id, location in freezer, etc. | |
| 436 | Ability to query from externals system the available material in sample inventory. ie samples stored in freezers, incubators, etc | |
| 437 | Ability to define and execute a material transfer order to issue material from sample inventory | |
| 438 | Ability to define and execute a material transfer order to store material in sample inventory | |
| 836 | Ability to retrieve information from external a system of record so that Apps can get the required information for execution fo a specific process step. | |
| 844 | Ability to transfer or send history records to external system of record. Record can be transferred in their entirety at the completion of a process or in parts as steps in the process are completed |
Intelligence
Analytics
| ID | Requirement | Implemented By |
|---|---|---|
| 245 | All tracked information must be available for analysis | |
| 464 | Ability to perform analysis on batch/lot and material history records. Ie query history records based on any attribute of the material | |
| 465 | Ability to query history records by any related dimension. Ie. equipment, user, work order, material, time, duration, etc. | |
| 832 | Ability to view and perform analysis on audit trail data | |
| 833 | Abillty to view and perform analysis on all captured data, including audit trail and annotations |
Reporting
| ID | Requirement | Implemented By |
|---|---|---|
| 244 | Ability to view and print a version of App that define a specific Master Batch Record (MBR) or Master Device Record (MDR). The report shall contain all steps, procedures, parameters, input materials, output materials, calculations, labels and annotations. | |
| 246 | All tracked information must be available for reporting | |
| 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 | |
| 462 | Ability to view and display the material history record for a specific batch/lot and material | |
| 463 | Ability to browse (view and display) forward and backwards batch/lot and material genealogy at all level of the material tracking hierarchy. | |
| 847 | Ability to view complete history record for material item production (Digital History Record). |
Visualization
| ID | Requirement | Implemented By |
|---|---|---|
| 13 | Provide visibility to approvals or tasks by user, group, role. | |
| 20 | Provide visibility to dependencies of master data definitions and models on model components. ie where used information on master data definitions, models and model components | N/A roadmap |
| 21 | Ability to search, view and report on master data based on tags/labels | |
| 60 | Data from connected end-points can be visualized as simple metrics | |
| 61 | Data from connected end-points can be visualized in graphical format such as gauges, indicator, dial, scales, etc. | |
| 247 | All tracked information must be available for visualization |
Models & Master Data
All Models
| ID | Requirement | Implemented By |
|---|---|---|
| 10 | Content can have multiple tags/labels to help with sorting and finding content | N/A roadmap |
| 11 | Provide a configurable workflow for approval of new or modified content (including connectors, components, tables) | |
| 15 | Provide ability to apply status to managed content. E.g. Development, In Review, Released, Published, etc. | |
| 16 | Manage the release to use of content based on approval status. | |
| 18 | Provide ability to manage one or more master data definitions or models simultaneously | |
| 22 | Ability to configure collections of user/reason codes to be used for classification of events and data during execution and defined in master data and model elements. | |
| 49 | Provide a managed way to configure and maintain content including creating, copying, editing, making obsolete, and deleting. | |
| 50 | Disallow deletion of content that have been used in execution of a work order or material processing. | |
| 52 | Content must have configurable workflow to require a review and approval by people with appropriate authority before they are published for use in production. | |
| 53 | All content must have configurable version control. | |
| 67 | Ability to build apps consisting of a number of pre-configured app components. ie for modularity and consistency | |
| 70 | Tulip has to display the current batch/lot currently being worked on | |
| 77 | Ability for content to display relevant process and production data as a metric. Ie. number, gauge, indicator etc. | |
| 78 | All contents have to guide operators thru the process steps in an easy intuitive manner. Ie. easy navigation between process steps | |
| 79 | All content has to display the current process step that is being worked on | |
| 80 | Ability for content to display documents including PDFs, formatted text, spreadsheet, diagrams, etc.. Ie work instruction documentation, product specification | |
| 81 | Ability to display rich media including Photo (JPG, BMP, PNG format), Video (MP4, MOV format) | |
| 82 | Ability for apps to display complex graphical media with zoom/enlarge capability including PDF, JPEG, PNG, and VGS. | |
| 83 | Ability to configure signature to complete a process step. | |
| 84 | Ability for content to guide operator thru the execution of a process flow model | |
| 87 | Content screens can be populated to the extent possible based on context of entered data. Ie. text fields, drop downs for users to selection, etc. | |
| 88 | Ability to designate certain content fields to be required for data entry | |
| 89 | Ability to configure alerts based on criteria of the entered data | |
| 90 | Ability to configure job aids for assistance. e. click on "help" to get instructions or show how-to procedure | |
| 91 | Ability for content to have text, drop down and check box fields for user input | |
| 93 | App has to provide navigation between process steps from external input. Ie. scanner, button, switch, I/O triggers, etc. | |
| 99 | Ability to display the acceptable quality limits to the operator during the execution with an indication of whether the current value is inside/outside the limits. | |
| 104 | All tracked information must be accessible and viewable for users in a workflow. | |
| 290 | Provide managed process execution that guides the user through the production process as defined in a Production Model including the workflow, process logic, validation requirements, process parameters, material inputs and material outputs. | |
| 458 | Provide a managed content repository to manage the distribution and deployment of content . Ie App "store" or "exchange"; a library of components | N/A roadmap |
| 459 | Ability to add additional information about content in the content repository including description, installation instructions, and rating. | N/A Roadmap |
| 853 | Provide the ability compare version of master data definitions and models including Apps, Connectors, Tables, and Components. | N/A roadmap |
Equipment Models
| ID | Requirement | Implemented By |
|---|---|---|
| 71 | Tulip has to display the current equipment being utilized if applicable | |
| 153 | Ability to configure actions for automaton system or equipment alarms by alarm severity | |
| 157 | Provide a managed way to configure and maintain definitions of equipment models including creating, copying, editing, making obsolete, and deleting. | |
| 158 | Disallow deletion of equipment model definitions that have been used in execution of a work order or material processing | |
| 160 | Support equipment model definition using hierarchies and equipment classes | |
| 162 | The equipment model should have definition of equipment classes and equipment groups. | |
| 163 | The equipment model should have definition of capability, availability, status, and reservations. | |
| 164 | The equipment model should have definition of location and assignments. | N/a roadmap |
| 167 | All equipment instances must be uniquely identified. | N/a roadmap |
| 169 | Provide a managed way to configure and maintain a state model for an equipment, equipment group or equipment class with allowed transitions (eg. "running" and "not running" - running state; "clean", "in use", "not clean" - cleaning state) | |
| 170 | Provide a managed way to configure state models so that state models can define definitions of configurable transition rules. The rules may be dependent on equipment status, material attributes, batch.lot attributes, etc. | |
| 186 | Ability to define and maintain equipment attributes. | |
| 197 | Ability to collaborate on definition of models including ability to simultaneously author/change model definition for equipment, material and production. | |
| 201 | Ability to define specialized equipment parameters and configuration for a process step based on assigned equipment or equipment class. Ie liquid handling and hitpick parameters or setup configuration | |
| 345 | Track current equipment current status and state transitions. State transitions including status before and after transition will be included in the equipment history logs. |
Material Models
| ID | Requirement | Implemented By |
|---|---|---|
| 94 | Ability to view material dispatching lists in a content. | |
| 95 | Ability to view material information for a batch/lot in an App. Information includes all material as part of a material hierarchy, ie. cohort, plate, well, etc.) | |
| 96 | Ability to view batch/lot dispatching lists in content | |
| 102 | Ability to display sampling plan requirements to user | |
| 103 | Ability to guide operator in execution of sampling plan. Ie extract materials from batches/lots and disposition of sample material | |
| 136 | BOM shall include definition of quantities and UOM for each BOM element | |
| 178 | Provide a configurable multi-level material tracking for batch, lot, plate/tray, well, unit, flask. | |
| 179 | Ability to assign material properties to any level of the material tracking hierarchy | |
| 180 | Ability to propagate material attributes to associated materials in the material tracking hierarchies. e.g. assigning material attributes to final product from intermediates. | |
| 188 | Standard non configurable material attributes must include quantity, UOM, status, expiration date, location, process step | |
| 190 | Ability to define a UoM and the conversion formulas and rules between UoMs |
Production Models
| ID | Requirement | Implemented By |
|---|---|---|
| 27 | Provide a managed way to define label templates and formats with process and operation specific parameters. Ie. parameters are replaced with specific values when labels are processed for printing during process execution | |
| 98 | Ability to view current process step in the context of the executing production model. | |
| 115 | Provide managed library of process and production model components or modules to be used in process and production model definitions | N/A roadmap |
| 118 | Ability to configure steps and states for work on orders, materials or equipment in a workflow | |
| 119 | Ability to configure procedural elements for work on orders, materials or equipment in a workflow | |
| 121 | Ability to define procedural sequences with relevant process information that can guide an operator through task execution. | |
| 122 | Ability to define process flows that can be executed in parallel with one another | |
| 123 | Ability to define process and material workflows structures that can be executed in sequence with one another | |
| 124 | Ability to define procedural elements in process and material workflows that can be repeated in sequence, ie configurable number of iteration of the same step both min. and max. number of iterations. | |
| 125 | Ability to define conditions to route process between steps in the workflow. These conditions can be based on state change in other steps or time constraints, equipment status, critical alarms, completion of other steps or defined timers. | |
| 127 | Disallow completion of work until all required processing steps have been performed. i.e. disallow batch close when there are incomplete processing steps. | |
| 130 | Ability to define criticality of process parameters in the process. Ie identify data columns as critical to quality. | |
| 133 | Ability to parameterize a process and production model definitions. Ie. create generic definition using parameterization that are substituted by specific production order information prior to release to production. | |
| 147 | Ability to provide formatted textual work instructions | |
| 148 | Ability to provide multi-media work instructions | |
| 150 | Ability to define steps and procedural elements that are triggered by time-based events such as timers or date-time. | |
| 151 | Ability to configure allowed overrides for steps and procedural elements. An override can be allowed for out of spec conditions and can require additional approval using e-signature | |
| 154 | Ability to use process values from previous process steps in any procedural element or step workflow. | |
| 252 | Verify equipment is in an appropriate state to begin processing. Eg. clean, calibrated, not already in use, etc. | |
| 255 | Ability to verify that equipment (room, suite, area, etc.) meets routine cleaning requirements and prevent process start if cleaning status requirement is not met prior to start of processing. | |
| 333 | Ability to execute processing logic and data collection triggered by equipment state transitions | |
| 346 | Provide a managed way to capture equipment events during production processing. All events will be logged with cause and timestamp. These events may be - Stop causes, Downtime events, Breakdowns, Repair, Etc. |
Non-functional
Maintenance
| ID | Requirement | Implemented By |
|---|---|---|
| 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. | |
| 46 | Provide safe and reliable start-up and shut-down of the system securing complete system and data integrity. | N/A non functional |
| 47 | Manage access to system administration and maintenance functions to users with appropriate privileges | |
| 55 | Provide a managed way to subscribe or install content in a specific workstation or processing area | |
| 834 | The solution including Apps, data and connectors shall be provided as a service. Ie Software as a Service | "N/A non functional |
| 835 | The solution including Apps, data and connectors shall be able to be installed on prem. | N/A non functional |
| 840 | Ability to support multiple languages and specialized characters. | |
| 850 | Ability to test Apps in production execution during the development and review process. |
Performance
| ID | Requirement | Implemented By |
|---|---|---|
| 838 | Comply with customer specific Recovery Point Objectives (RPO). Eg. RPO of 0 hours, so that no data is lost upon failure. | N/A non functional |
| 839 | Comply with customer specific Recovery Time Objectives (RTO). Eg. 72 hours, so that no more than 3 day’s production is lost in the event of failure | N/A non functional |
| 841 | Apps need to support business critical operations and comply with customer specific uptime requirements as defined in SLAs. Eg. 99.99% | N/A non functional |
| 842 | Support specific number of concurrent users as defined by customer license agreements and SLAs | |
| 843 | Apps need to support business critical operations and comply with downtime requirements as defined in SLAs. Eg. downtime is only scheduled during non-production hours, or agreement with customer. | N/A non functional |
System
| ID | Requirement | Implemented By |
|---|---|---|
| 12 | Ability to assign and notify multiple users for a given approval workflow of all content. | |
| 14 | Ability to automatically escalate overdue approval or tasks. | N/A not supported |
| 34 | System date and time cannot be changed by users during normal operation and production execution. Only admin with appropriate privileges can change system date and time. | |
| 38 | Date and time must be displayed in the current locale | |
| 39 | Support daylight saving time bi-annual hour changes | |
| 40 | Support leap years date adjustment automatically | |
| 56 | Apps can be used without external keyboard and mouse. | |
| 66 | Tulip can be used in environment where operators wear gloves. i.e. sterile or clean areas where the operator is gowned up and has gloves on | |
| 72 | App has to display the time elapsed since starting a process step | |
| 73 | Ability for apps to display rich media. ie. audio video | |
| 75 | Ability to send notifications from any content screen. Ie. email, txt message, alarms. | |
| 105 | Support of Tulip operation on mobile devices | |
| 461 | Only approved content can be used for production execution activities | |
| 851 | Provide portability of configuration and components with full version, audit trail and history information. Ie. models and components can be exported and imported between environments and instances. | N/A Roadmap |
| 852 | System must provide accurate time server synchronization and shall utilize the same time source. |
Production Management
Execution
| ID | Requirement | Implemented By |
|---|---|---|
| 76 | Ability for content to display relevant process and production data in either graphical format. Ie. pareto, bar graphs, pie graph | |
| 85 | Tulip has the ability to upload photos and videos as part of execution. | |
| 86 | Tulip has the ability to capture photos during execution. | |
| 258 | Ability to complete steps with process values that are not within the predefined limits if appropriate exception/deviation information and approval is entered | |
| 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. | |
| 260 | Ability to track equipment use in production execution by material unit and work order. | |
| 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 | |
| 291 | Provide sequence management of process steps so that Apps can get required information for execution of a specific process step | |
| 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 | |
| 295 | Verify that all required data has been entered and collected as prescribed by the step on completion. Disallow to progress on execution path if verification fails | |
| 296 | Prompt for, verify and capture an e-signature as part of a step execution if an e-signature is required in the step's configuration | |
| 297 | Provide a managed and authorized way to capture (log) and document any deviation from normal process execution as exceptions. An exception log will include a reason, risk category, and comments. | |
| 298 | Require e-signature for exception of specific configured risk categories. Ie for high severity or high risk exception require the capture of an e-signature in the history record | |
| 300 | Provide a managed and authorized way to capture (log) and document any comments or exceptions during process execution. | |
| 301 | Ability to re-execute process step respecting any constraints of the process step configuration in the process flow. | |
| 302 | Ability to re-execute process step with override of constraints of the process step configuration in the Master Recipe or material workflow. In such a case an extra e-signature can be required. | |
| 326 | Ability to route and disposition materials based on sampling plans Eg. hold or future hold materials until sample testing results are available | |
| 327 | Ability to route and disposition materials based on results of sample testing (off-line) and/or quality testing (in-line) Eg. hold, reject, scrap, or release materials based on sample result | |
| 329 | Verify entered data is within configured limit and tolerances as configured in the Master Recipe or material workflow process step, and material model. Allow authorized override of this constraint based on configuration | |
| 330 | Ability to automatically or manually log an exception when data is not within configured limits and tolerances. Disallow process completion until exceptions have been logged with configured e-signatures and any authorized overrides have been processed e.g. supervisor signature, scrap, etc. | |
| 358 | Provide configurable way to review exceptions | |
| 406 | Ability to consume by pre-configured unit of measure (UoM) quantities such as weight, volume, etc. | |
| 428 | Ability to adjust batch/lot and material quantities related to sample plan execution | |
| 857 | Ability to print configured labels for sample materials |
Monitoring & Tracking
| ID | Requirement | Implemented By |
|---|---|---|
| 25 | Material history records must include exception approval log. | |
| 261 | Ability to track equipment substitution during process execution. | |
| 303 | Ability to track batch/lot and material rework based on the Master Recipe or material workflow configuration. | |
| 309 | Ability to track use of one source material or load-carrier used for multiple orders Eg. bulk material that is used for different products. | |
| 317 | Ability to track multiple dispensing of the same material continuously for different work orders or batches/lots as part of a campaign | |
| 337 | Ability to track material consumption in a process step. Material consumption may include processing, assembly, weighing, dispensing, etc. | |
| 347 | Ability to track all WIP materials at all material hierarchy levels including batches, lots, and materials. Ie. material tracking history will include all activities performed on materials including issue, consumption, processing, mixing, assembly, movement, transfer, etc. | |
| 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 | |
| 350 | All material tracking history will include context of material hierarchy levels | |
| 351 | All material tracking history will include date and time stamps | |
| 352 | All tracking history information must be retained for historical review and analysis for a configurable retention period | |
| 354 | Ability to track material association to work order and production order at all levels of material tracking hierarchy | |
| 356 | All tracked information and logs will be available as part of material and process history records. | |
| 357 | Ability to track material consumption and use at all levels of the material tracking hierarchy. | |
| 363 | Ability to track and maintain forward and backwards batch/lot and material genealogy at all level of the material tracking hierarchy. Ie view, analyse and query material genealogy | |
| 385 | Ability to track equipment location for mobile equipment. The equipment log will include the equipment's location history or path. | |
| 388 | Ability to track material inventory and its physical location. | |
| 389 | Ability to track material movement history. Ie. path of material in the production process | |
| 390 | Ability to track materials associations using the material tracking model. Ie. track physical material in tray location, trays in batches (Cohorts). | |
| 392 | Ability to track materials handled in load-carriers. | |
| 393 | Ability to track loading of material to a load-carrier and its location within the load carrier. Ie. material in a well, plate, flask, tank, tote, etc. | |
| 394 | Ability to track unloading of material from a load-carrier | |
| 396 | Ability to track and list materials for a work order for reconciliation. | |
| 405 | Ability to manage and track material consumption as part of a process step. Material consumption may include processing, weighing, dispensing, etc. | |
| 407 | Ability to track of material waste and scrap as part of the production process execution. | |
| 427 | Ability to track material attributes during production operations with associated capabilities to browse their history and their trending e.g. temperature, assays, etc. |
Planning
| ID | Requirement | Implemented By |
|---|---|---|
| 202 | Ability to define effectivity to and from dates for content |
Preparation & Dispatching
| ID | Requirement | Implemented By |
|---|---|---|
| 253 | Disallow steps from completing until the correct material, material quantity, has been consumed or identified | |
| 274 | Ability to start processing for work orders by starting to track material (batches, lots, units, etc.). Tracking information should respect tracking hierarchy (kits, trays, wells, flasks, jigs, etc.) | |
| 276 | Work order have to be approved and released for production before any material can be started. Ie starting batches/lots | |
| 277 | Ability to view dispatching list by equipment. Ie for any element of the equipment hierarchy such as area, machine, work center, etc. | |
| 278 | Dispatch priority of work orders and batches/lots can be controlled using predefined configurable dispatching strategies | |
| 288 | Ability to track dispatching of work orders and materials to production once they are released. | |
| 289 | Ability to exclude a work order from the dispatch list. | |
| 456 | Ability to define and dispatch work orders for the different segments of the manufacturing operation. | |
| 457 | Ability to define work order types to indicate special processing or release procedures. Ie normal, testing, prototype, validation, rush, etc. |
Resource Management
Equipment Control
| ID | Requirement | Implemented By |
|---|---|---|
| 97 | Visibility to equipment allocation during work order and batch/lot execution to determine future equipment availability during dispatching activities | |
| 168 | Ability to provide an equipment inventory list by use. Ie. material batch/lot (Cohort), Master Recipe, material workflow, equipment model, etc. | |
| 185 | Ability to define quantity and capacity constraints for equipment | |
| 231 | Ability to transfer configuration and parameters to equipment for process setup | |
| 344 | Ability to track all equipment status and movement if relevant. Ie. equipment tracking history or equipment logs will contain complete history of activities performed by or on an equipment | |
| 371 | Ability to control automated equipment state (start, stop, pause, resume, etc.) during the execution of a process step. | |
| 372 | Track the real-time status of all equipment instances | |
| 378 | Ability to assign operators to equipment or equipment group at login. | |
| 386 | All maintenance activities on equipment will be tracked and maintained as part of the equipment logs. i.e. calibration, PMs, repairs, etc. | |
| 450 | Ability to guide operators through equipment specific tasks. Ie loading and unloading of trays, setup, cleaning, etc. | |
| 900 | Equipment & cleaning log - The system must be able to create logs for registration of use, maintenance, calibration & cleaning of equipment and rooms. |
Material Control
| ID | Requirement | Implemented By |
|---|---|---|
| 215 | Ability to receive production order from a system of record with associated material list | |
| 391 | All materials must be identifiable through auto-id (e.g. barcodes) | |
| 426 | Ability to transfer sample material as defined in sampling plan |
User Control
| ID | Requirement | Implemented By |
|---|---|---|
| 24 | Provide a managed way to define and maintain definitions of a user model including creating, editing, and disabling of users. | |
| 28 | Provide a method for defining privileges to Master Data access and modification by role at element level. Eg. configuration of role or user group for a App or App component and what privileges they have such as view, comment, edit, approve, etc. | |
| 29 | Access and use of system and its components shall be limited to authorized users. | |
| 32 | All Users have to be uniquely identified | |
| 44 | Ability to revoke user access to the system both permanently and temporarily with appropriate authorization | |
| 45 | Ability to send notifications about any disabled user accounts within 1 minute of occurrence | N/A non functional |
| 114 | The user model includes ability to define access control to all elements of the system including libraries, administration, transactions, functions, apps, integrations, analytics, reporting, etc.c | |
| 375 | The user model includes ability to define access control for execution of model components. Ie. users, roles, groups that are allowed to execute a process step, data collection, completions, etc. | |
| 380 | Ability to manage and track multiple users as working on the same process step. Ie. process execution of work order, batch, lot, material, etc. | |
| 854 | Creation, change, and cancellation of access authorizations should be recorded. |