Tempo v6.5 Release Notes

Introducing the Tempo v6.5 release

• New packages
  • Laboratory Execution System (LES)
  • Augmented Work Instructions (AWI)
• General platform updates
• Procedures & batches
• Locations & resources
• Integrations

New packages

Laboratory Execution System (LES)

Added
Built for the modern quality control lab, Apprentice's Laboratory Execution System (LES) helps organizations release batches faster with real-time quality control. Scientists can author rich digital work instructions, manage samples and lab resources at scale, and execute test methods on mobile and wearable devices.

The Tempo LES package includes the following components:

• Procedures
• Exceptions
• Locations
• Equipment
• Materials
• Samples
• Integrations
• Tandem

It also works seamlessly with Tempo MES package functionality to eliminate delays and drive action on real-time quality feedback across all production teams. Empower your scientists and operators to work together to prevent deviations and achieve faster batch release.

New functionality developed for LES includes:

• Samples
• Sampling action
• Arrays
• Load Plate action
• Sample and Sample Plate Table inputs
• Table Formula action

Samples

Added
A sample is typically taken from a pharmaceutical batch and is used for testing the quality of the drug being produced. LES allows users to add, manage, and organize samples and sub-samples within the system.

Samples are organized into classes and subclasses within LES. The name, description, standard properties, and result (custom) properties of classes and subclasses can be managed according to an organization's preferences.

Users can add samples manually from the new Samples page (cloud Tempo > Samples > Samples) or during the manufacturing process using the Sampling action described below. Sub-samples can also be aliquoted from a parent sample as needed.

Once a sample has been added to Tempo, users can review or manage that sample's information, usage log, history, sub-samples, and attached procedures, as applicable.

When building a test method procedure template, the author can define the class, subclass, range, total replicates, and dilution properties of the sample for the specific test method. The author can also use the Resource input to prompt an analyst to scan a sample.

When working with a sample test plan batch run, the quality control supervisor can allocate samples on the Parameters tab on a batch run.

For additional information on samples, review the Samples Overview article.

Sampling action

Added

A requirement of pharmaceutical drug manufacturing is to create or take samples as part of the manufactured drug product and perform testing on the samples to ensure that the drug is of high quality prior to release. These samples need to be created, identified, and tracked. To support this requirement, procedure templates now support two sampling actions so that operators can create new sample inventory during batch execution:

• Create Sample: Instructs the person executing the procedure to create a new sample.
• Take Sample: Instructs the person executing the procedure to consume material in order to take a sample from an existing material sublot.

When an operator completes the sampling action, the system creates a new sample ID and prints a label, if required. The system automatically associates the primary output lot number from the batch run with the sample.

Arrays

Added

An array can be any plates, boxes, gels, or other physical holder to hold samples. LES allows users to add, manage, and organize arrays within the system. In addition to tracking the arrays themselves, LES also tracks configurable zone information for where samples should be and are loaded onto the array during testing.

Arrays are organized into classes and subclasses within LES. The name, description, and properties of classes and subclasses can be managed according to an organization's preferences.

Users can add arrays from the new Arrays page (cloud Tempo > Arrays > Array Instances). Once an array has been added to Tempo, users can review or manage that array's information, layout, usage log, attached procedure runs, and history, as applicable.

When building a test method procedure template, the author can define the class, subclass, and zones of the array for the specific test method. The author can also prompt an analyst to scan an array using the Resource input and to load an array using the Load Plate action described below.

Load Plate action

Added
A requirement of pharmaceutical drug testing is to ensure tracking of samples within any arrays used for testing. The Load Plate action provides a visual grid with the mapping information an analyst would need to determine placement of different standards or samples. Once loaded, this grid also provides access to traceability information for each loaded sample.

Sample & Sample Plate Table inputs

Added
Two new Table input types, Sample and Sample Plate, facilitate recording data related to sample testing within the LES.

• Sample: A Sample table allows data to be recorded manually by an analyst in a table format. This table type is designed for cases where a procedure does not use the Load Plate action.
• Sample Plate: A Sample Plate table allows data to be recorded via an instrument integration (i.e., with TetraScience) or manually by an analyst in a table format. This table type requires the previous use of the Load Plate action as part of the procedure for traceability.

Table Formula action

Added
The new Table Formula action allows the author to set a source Sample or Sample Plate table and determine how to group testing results.

Performing mathematical calculations, such as mean, sum, or standard deviation, on data entries within a table is common practice within pharmaceutical manufacturing. This action requires the specification of a Sample or Sample Plate source table and can support various groupings that the data may require, including grouping by sample or dilution. The output is then calculated during run execution.

Augmented Work Instructions (AWI)

Added
Apprentice’s Augmented Work Instructions (AWI) is the only cloud-native, digital work instructions software built for pharma. Operators and scientists can author and augment digital work instructions, execute procedures on mobile and wearable devices, and ingrain quality into steps with exception handling.

Use AWI as a first step towards digitization. With AWI, a site can set up the foundation for a platform, Tempo, that can scale to a MES and LES.

The AWI package includes the following components:

• Procedures
• Exceptions
• Tandem

AWI is available to purchase on its own, or bundled with other packages in our Tempo Manufacturing Cloud. For more information on AWI, refer to the Augmented Work Instructions page of the Apprentice website.

General platform updates

Unified package environment

Enhanced
With v6.5, all of Apprentice's packages are available within a single environment. As part of this update, roles and permissions were identified across Apprentice packages and minor improvements were made to ensure all solutions within the Tempo Manufacturing Cloud include an accurate roles and permissions model.

Tandem External role update

One update related to roles and permissions in 6.5 is a change to the Tandem External role (previously referred to in Tandem systems as External. With other roles in the system, a user assigned multiple roles receives all permissions associated with those roles. However, the Tandem External role overrides any other permissions and will prevent any user who is assigned the Tandem External role from accessing additional system functionality.

Refreshed platform navigation panel

Enhanced
The Tempo Manufacturing Cloud has been updated to include a newly-designed navigation panel. The refreshed navigation panel, which continues to live on the left side of the user interface (UI), delivers a more modernized experience for the user.

List of navigation panel changes

• The way users access the navigation panel has changed. Previously, users hovered over the panel with their cursor to expand the menu on the web application. Now, users click keyboard_double_arrow_right Expand in order to interact with the full navigation panel.
• Previously, the names of available system components displayed in the navigation panel, organized by package. Now, users access available system components by clicking the relevant package icon, then selecting the related component from the expanded panel.
  • cloud Tempo
  • Tandem
  • Business Intelligence
  • settings Platform
  • account_circle Profile
  • logout Log out
• Samples and Arrays have been introduced to the Tempo section of the navigation panel to support the new LES product and its functionalities.
• The Organization section of the navigation panel was renamed to Platform. The Platform section still includes the same system features as before (Configuration, Users, User Groups, Devices, Locations, Statuses).
• Integrations, Transfers, Events, and Unit of Measure are new MES and LES features, which are now located within the Platform section of the navigation panel.
• The Groups section, which is located under Platform (previously Organization), was renamed to User Groups.

Unit of Measure configuration page

Added
Units of measurement are used in many places across the platform, and each organization may have specific sets of units that are relevant to them. In order to simplify an organization's experience with units of measurement, users with relevant permissions can now select the relevant units for that organization's system via the Units of Measurement page (settings Platform > Unit of Measure).

The list of units of measure consists of hundreds of standard units that span across different categories such as mass, volume, time, and more. From this page, users can enable or disable specific units of measure in the system, as well as designate or disable specific units for use in inventory tracking of materials.

Immutable system resource and object IDs

Enhanced
In order to ensure uniqueness over time, the following name or ID fields have been made read-only after creation:

• All resource Classes: Name
• All resource Subclasses: Name
• Material lot: Lot number
• Material sublot: Sublot name
• Location: ID
• Status: Name
• Groups: Group ID
• Integration: Name
• Equipment Instance: Equipment ID
• Samples: Sample ID
• Material Definition: Material ID
• Array Instance: Array name

Procedures & batches

In-suite authoring for procedure templates

Added
In order to eliminate back-and-forth between authoring and testing a draft procedure, the Tempo iOS app now offers a Designer Mode for users to propose modifications to draft procedure templates.

While in Designer Mode, users can mark steps and content for addition, deletion, or modification.

Changes proposed on the iOS app can be reviewed by procedure authors within the procedure template on the web app. From the web app, procedure authors can review, modify, and confirm added, deleted, or modified data.

Import steps from another procedure template

Added
To improve the procedure authoring experience, users can now copy existing steps from another procedure template into a draft procedure template within the same system. Imported steps maintain information from the original, such as instructions, inputs, actions, signatures, and step navigation. When importing steps, the user should review and can adjust any information that requires updating.

This new functionality is available for all draft procedure templates, whether they are based on a PDF source document or fully digital.

• If the draft procedure template is based on a PDF, the user can import one step at a time by selecting the relevant text area > file_download Import Step.
• If the draft procedure template is fully digital, the user can import one or more steps at a time using the Import Steps button on the procedure template Augmented Steps page.

For additional information on importing steps into a procedure template, review the Creating & Managing Augmented Steps article.

Batch and procedure template report

Added
To ensure the ease of reference for batch and procedure template documents outside of the system, a new template report button displays on batch and procedure templates. This button allows users to print a hard copy or export a PDF that includes the information from any specified tabs on a batch or procedure template.

Batch and procedure template archiving

Added
At the end of the lifecycle of a template, authors may choose to archive a template that will no longer be used.

If a template is archived, this prevents users from starting new runs, importing steps, duplicating, or otherwise engaging with the template. However, users with appropriate permissions can review the information, history, and revisions related to the archived template. This information is available on a new Procedure Templates (Archived) page available via cloud Tempo > Procedures > Templates > more_vert More Options.

Standard deviation operator for procedure template Formula & Table Formula actions

Added
In order to support the calculation of the standard deviation of a list with values during execution, Formula and Table Formula actions now support standard deviation as an advanced operator.

Batch run parameter improvements and additions

Added
A variety of improvements have been made to provide an organized, user-intuitive layout for batch run parameter management.

The new Parameters tab on a batch run provides a single place to reference and update material, equipment, process, and sample parameters. This tab replaces the previous Process Parameters and parameter information from the BOM/BOE tab. (Other elements from the BOM/BOE tab now display on the new Batch run Resources tab, described below.)

The Parameters tab displays the relevant information about a batch run's parameters. From this tab, a user can apply a batch parameter group (described below), update parameters, and/or allocate material or sample inventory.

Additionally, the user experience for overriding a parameter value on a batch run has been simplified. The override dialog now provides additional information to users regarding the parameter and more guidance regarding static and dynamic overrides.

Procedure and batch run Resources tab

Added
The new Resources tab on a procedure or batch run captures all inputs and actions that reference or use equipment, materials, or samples and displays them in a single place for ease of reference. From this tab, users can review everything related to these resources that occurred during a run. This tab replaces the specific resource information from the BOM/BOE tab.

Batch parameter groups

Added
Within Tempo, parameters help provide flexibility in a single batch template, but previously required manual review and update for each batch. The new batch parameter group feature allows for specific sets of parameters to be saved, managed, approved, and applied as a group. This reduces the number of recipes and configuration time required while also reducing the opportunity for parameter data entry errors in a batch run.

After creating a batch template and making it effective, a user can create a new batch parameter group for a specific batch via the new Parameter Groups page (cloud Tempo > Batches > Parameter Groups). After the user reviews or updates all parameters within the group, the parameter group can be sent for review and approval following the same approval workflow as procedure or batch templates, if required.

Once a batch parameter group has been locked and made effective, it can be applied to a batch run that has not yet been started using the new Use Parameter Group button on the Parameters tab. When applied, the group overrides all of the parameter values set within the batch. (If circumstances require, the values from the group can also be overridden.)

Batch template dynamic and static parameter values

Added
To support additional clarity during batch template authoring and approval, a user may now define static and dynamic parameter overrides while drafting a batch template, rather than waiting to define these on the batch run.

Dynamic ranges based on batch-specific parameter values

Added
With previous releases, procedure authors have been able to set a specific number or formula result for the upper and lower bound of an acceptable value range for certain kinds of inputs and actions.

Now, when appropriate, authors can set the acceptable value range in the following areas of the system using batch parameter functionality as well:

• Value input: Number type
• Measure input: Manual Entry type
• Formula actions
• Dispense action: Manual Dispensing Mode

This allows for more flexibility to create a single standardized procedure template that can accommodate various batch sizes and other characteristics. The upper and lower bound for these values can then be updated for each batch run according to any specific needs of that run.

User assignment for procedure runs

Added
In addition to assigning users to batch runs, Tempo now supports assigning users to procedure runs via the procedure run’s Assign tab.

Document assignment for procedure templates and runs

Added
In addition to assigning documents to batch templates and runs, Tempo now supports assigning documents to procedure templates and runs via a new Documents tab.

Sampling action within procedure templates

Added
Procedure templates now support two sampling actions. Organizations that use Tempo MES and do not use Tempo LES cannot store information about a sample within the system using these sampling actions, but they may use these actions to reduce material lot inventory and/or print a label, if required.
For additional information on how this functionality supports organizations that use both MES and LES, refer to the Sampling action release note entry in the LES section of release notes.

Locations & resources

Resource transfer

Added
System admins can now use a new Transfers page (settings Platform > Transfers) to copy certain resource information from their development or test environment to their validation environment or from their validation environment to their production environment.

The following resource information can be transferred:

• Materials
• Equipment
• Locations
• Statuses
• User groups
• Sample classes and subclasses
• Array classes and subclasses

When resources like materials and equipment are imported, information related to those specific resources (e.g., class, subclass, locations, statuses, etc.) is also imported.

Material lot potency

Added
The potency of the active pharmaceutical ingredient in materials can differ based on the material lot. Users can now manually record the potency value for new and edited material lots via a new Potency % field.

• For new material lots, the Potency % can be recorded during the addition of the lot (cloud Tempo > Materials > Material Definitions > select the material > Material Lots > New Lot).
• For existing material lots, the Potency % can be recorded by editing the lot (cloud Tempo > Materials > Material Definitions > select the material > Material Lots > locate the lot > Edit Lot).

Integrations

This release provides customers with the capability to configure secure integrations with the critical systems and equipment their organization uses to manufacture their products.

No-Code Integrations

No-code integrations enable organizations to connect to critical systems quickly and immediately leverage them during processes such as procedure authoring. This release will include no-code integrations for the following platforms/protocols:

• Ignition SCADA
• OSIsoft PI
• Veeva
• OPC UA
• TetraScience
• Ganymede
• DeltaV

Ignition SCADA

Added
Ignition is a SCADA (supervisory control and data acquisition) platform utilized in many Commercial Manufacturing Sites around the world. This integration will include the following features and capabilities:

• Connect directly to a SCADA System
• Redundancy + failover support
• Full tag browse support during procedure authoring
• Read or write values to any tag in your SCADA parameter hierarchy during a procedure step
• Easily integrate to devices and systems directly connected to your SCADA system

Use Cases:

• User needs to record process data from equipment during procedure execution instead of taking a manual reading
• User needs to write data back to their SCADA platform during a batch run

Supported data types: Boolean, Byte, Short, Integer, Long, Float, Double, String, DateTime (Read Only)

OSIsoft PI

Added

The PI System is widely and commonly used across the pharma industry for time-series based process historians in the life sciences industry. The purpose of this integration is to allow any aspect of the PI System to be both read or written to from Tempo. In addition, the option to automatically create PI Event Frames for both individual procedures and entire batch operations is configurable via a simple checkbox during authoring. This integration will include the following features and capabilities:

• Connect directly to the PI Web API
• Redundancy + failover support
• Full tag/attribute browse support during procedure authoring
• Read or write current or historical values to your data historian’s data archive tags as well as its asset framework attributes
• Enhanced batch capture support
  • Ability to capture metadata associated with a Tempo batch into PI (Event Frames)
    • Batches
      • Configuration Information
      • Start/End Times (for Batch and Unit Ops) and Planned Start/End Times (for Batch)
      • Signatures
    • Procedures
      • Configuration Information
      • Dynamic Content
      • Start and End Time
      • Links
      • Resources
      • Signatures
      • Inputs
  • All batch/procedures available for viewing in a Gantt chart view for easy leveraging in business analytics
• Get an overview of a full Tempo batch run at a glance

Use Cases:

• User is taking manual samples and needs to add the sample results to their PI Historian with the timestamp the sample was taken.
• User needs to record process data from equipment during procedure execution instead of taking a manual reading
• User wants to perform advanced analytics in their PI System by comparing Tempo Batch Runs in a Gantt chart view

Supported data types: Digital, Float16, Float32, Float64, Int16, Int32, String

Veeva

Added
Veeva is an application built on the Salesforce platform designed specifically for the pharmaceutical and biotechnology industries, often leveraged for Quality, Document Management, and Training. This integration will include the following features and capabilities:

• Connect directly to your Veeva Cloud Environment
• Sync Tempo exceptions to Veeva QMS as deviations
• Easily monitor the status of a synced Veeva exception within Tempo
• Import Veeva images/videos into Tempo as Technique Media
• Sync Tempo Technique Media into Veeva
• Create Tempo procedures by downloading Veeva documentation and adding in augmentations via the Tempo procedure authoring workflow

Use Cases:

• User needs to send Tempo exceptions to Veeva to perform a CAPA
• User wants to use a document in Veeva as a starting point for procedure authoring
• User wants to leverage training media in Veeva within Tempo

OPC UA

Added

OPC is an interoperability standard for the secure and reliable exchange of data in the industrial automation space and in other industries. This integration will include the following features and capabilities:

• Connect directly to any OPC UA Server
• Redundancy + failover support
• Full tag browse support during procedure authoring
• Read or write values to any tag in your OPC Hierarchy during a procedure step
• A seamless flow of information among systems/devices from multiple vendors.

Use Cases:

• User needs to record process data from equipment during procedure execution instead of taking a manual reading
• Most sites leverage a OPC UA middleware layer for real time process data. This integration facilitates read/write functionality to any systems integrated with a clients middleware layer.

Supported data types: Boolean, SByte, Byte, Int16, UInt16, Int32, UInt32, Int64, UInt64, Float, Double, String, DateTime.

TetraScience

Added
The TetraScience no-code integration allows for a robust integration of on prem equipment to the Tempo platform. This integration will include the following features and capabilities:

• Connect directly to on prem equipment at a customer site to capture results data as part of the LES process
• Allows for select TetraSciences Schemas to be directly imported into Apprentice (read from TetraScience)

Use Cases:

• Collect overall equipment results
• Collect detailed equipment sample results
• Collect sample plate results

Ganymede

Ganymede is an equipment integration platform leveraged in the life sciences industry. This no-code integration will allow for a robust integration of on prem equipment to the Tempo platform.

• Connect directly to on prem equipment at a customer site
• On prem edge device controls remains in communication with local equipment to ensure smooth operation in the event of an internet outage
• Immediate access to KPIs for Ganymede connected equipment via an easy to browse integration
• Easy Integration with supported devices and systems directly connected to Ganymede

Use Case:
MES Systems are required to have a robust Scale Integration Solution to support Weigh and Dispense Operations
Supported devices: All Major Brand Scales (Mettler Toledo, Sartorius, Ohaus) to enable Weigh and Dispense

DeltaV

Added
“DeltaV is a distributed control system (DCS) widely utilized in the life sciences industry and directly responsible for operating the on prem equipment that facilitates drug manufacturing. The TetraScience no-code integration allows for a robust integration of on prem equipment to the Tempo platform. This integration will include the following features and capabilities:

• Connect directly to your DeltaV OPC UA Server for real time data collection of critical process values from plant level equipment
• Connect directly to your DeltaV Alarm & Event Database (or replicated data server)
• Supports Dynamic trigger conditions enabling operators to ingest alarms & events based on criticality and other factors to ensure only valid alarms are captured
• Directly View DeltaV Alarms and Events within the Tempo System

Use Cases:

• As a user, I need to pull critical DeltaV Alarms and Events into my MES platform in the event that immediate action is required and I do not have access to DeltaV

Enterprise Middleware / Connectors Integrations and Event Driven Architecture

In addition to no-code integrations, Tempo supports integrations to our ERP APIs via Enterprise Middleware Systems such as SAP BTP, Boomi, Mulesoft, and many others. Additionally, Tempo triggers output to RabbitMQ (event broker) for consumption by middleware to ERP and other external systems.

ERP

Added
Enterprise Resource Planning (ERP) is a type of software that organizations use to manage day-to-day business activities such as accounting, sales, procurement, compliance, and supply chain operations (e.g., SAP, Oracle, D365 etc.) The purpose of this integration is to allow customers to align master data, inventory and production runs between ERP and Tempo. This integration will include the following features and capabilities:

• Streamline complex ERP integrations
• Sync master data (materials, equipment), inventory, status and batch runs
• Easily monitor the data exchange between systems via Tempo integration logs

Use Cases:

• An MES system needs to get critical data and Events into the MES platform such as Materials, Inventory (lots), Process Orders (Batch Runs) and Equipment from ERP
• ERP Integrations
  • Inbound from ERP to Tempo:
    • ERP Material Master data → Tempo Material Definition
      • As part of this integration you can auto create Material Class, Sub-Class and Unit of Measure.
    • ERP Batch and Inventory → Tempo Lot and inventory
    • ERP Equipment → Tempo Equipment Instance
    • ERP Process Order → Tempo Batch Runs
• Outbound Events from Tempo:
  • Batch Run status
  • Inventory Movements
  • Inventory Consumptions
  • Inventory Creation

Public API

Added
The Apprentice Public API is a RESTful API which can be used to create your custom application. Access is granted via an API Key and Secret which can be assigned to specific permissions groups. This ensures that your custom app is only given the specific permission you desire; nothing more, nothing less. The API has both a major and minor version to allow for backward compatibility and continuous updates, while providing you ample time to upgrade your custom app if so desired. Learn more by going into reading Apprentice's Public API documentation.

Use Cases:

• Your company has a unique need which isn’t solved by a no-code integration
• Your company wants to extend Apprentice functionality
• Feeding data into BI platforms via or an ETL pipeline
• Start procedure sample runs from LIMS systems