Tempo v6.3 Release Notes

Introducing the Tempo v6.3 release

Tempo is the intelligent, all-in-one manufacturing solution for life sciences that works seamlessly across all stages of drug production. Designed around the needs of scientists, Tempo is built for speed and flexibility; it allows resource definitions, master recipes, and production data to be shared instantly across teams – making the tech transfer process quick and easy.

The Tempo v6.3 release includes, but is not limited to, new features and enhancements to optimize production, maintenance, and decision making:

• Quality review process: Ensure procedures and batches deliver the highest level of quality.
• Intuitive procedure authoring: Develop comprehensive templates and resources with ease.
• Self-service experience: Empower supervisors and authors with the information and actions they need.
• System role and user interface (UI) updates: Manage roles and access features intuitively within the system.

Quality review process

Tempo v6.3 includes a variety of new features and enhancements that ensure procedures and batches deliver the highest level of quality.

Printed procedure and batch run reports

The following enhancements have been made to procedure and batch run reports:

• Improved the look and feel of run reports. They now more closely resemble the reports displayed within the Tempo MES web application.
• Added the ability to print a complete procedure and batch run report or export it to PDF.
• Added the ability to require users to enter a password to print, annotate, or access a report.

For additional information on the procedure run report, refer to the Printing or Exporting a Procedure Run Report article. For additional information on the batch run report, refer to the Printing or Exporting a Batch Run Report article.

Critical value identification for relevant inputs and actions

A new Review field within procedure templates allows procedure authors to identify a specific input or parameter as a critical process parameter, critical quality attribute, or other reviewable value. This field is available for Value, Measure, and relevant Parameter inputs, as well as Formula actions.

When an operator reaches one of these inputs or actions during execution, the value records to the procedure or batch run and the system handles the critical value according to the system's critical value exception configurations.

For additional information about the Value, Measure, and Parameter inputs or Formula action, refer to the relevant sections of the Understanding Input Types & Options and Understanding Action Types & Options articles. For additional information on configuring exceptions, refer to the Configuring Exceptions article.

New exception and critical value system configurations

In order to allow quality managers to better prioritize exception and critical value review, administrator users can now determine the severity and signature requirement, if applicable, for exceptions and critical values. These configurations are managed via Configuration > Exceptions.
For the purpose of determining severity and signature requirements, all exceptions and critical values are grouped into the following types:

• Critical values
• Process exceptions
• Process notes
• Resource exceptions
• Value exceptions

Each exception or critical value type can be configured to either trigger or not trigger an exception, which will add an item for review on the Exceptions page. For types that trigger an exception, the exception can be automatically assigned a severity of low, moderate, high, or critical; they can also be configured to require either one or two signatures for approval.

For additional information, refer to the Configuring Exceptions article.

Exception execution blocking at the procedure level

Procedure authors may now configure at a procedure template level whether specific exception types should block operators from continuing to execute a procedure or batch run. These settings are disabled by default and can be enabled for one or more exception and critical value type via the More Options icon (three dots) > Template Exception Settings.

If an operator is blocked from progressing within the procedure, they may view the procedure in preview mode but may not take additional action until the associated exception is approved.

For additional information about managing template exception settings, refer to the Template Exception Settings section of the Creating a Procedure Template article. For additional information about exception blocking as part of the operator experience, refer to the Exception Blocking article.

Updated page for exceptions review

The following updates have been made to the Exceptions page to make it easier for quality managers to review exceptions and critical values:

• Enhancements to the Exceptions page UI to increase readability, including an organized view for exception context information.
• Addition of Trigger Event, Procedure Run Label, Step Name, and Batch Run ID column options.
• Enhancement to Procedure Run link, which now opens the specific step that prompted the exception.
• Enhancements to support streamlined review of critical value and exception initial entry and override values, as applicable.

Improved visibility into conditions and exceptions on iOS

To make it simpler for operators to understand the conditions for specific inputs and actions, the iOS app now provides the following cues for operators:

• A Scan Conditions button allows the operator to launch the material, equipment, or location input conditions configured for the resource from the Scan Code tool.
• When an input triggers an exception during procedure or batch execution, an error explanation displays in red text.

Intuitive procedure authoring

Tempo v6.3 includes a variety of new features and enhancements that allow procedure authors to develop comprehensive templates and resources with ease.

Enforced sequentiality in procedure and batch execution

Enforce Sequentiality, a new setting to enforce sequentiality within a procedure or batch run, has been added to procedure and batch templates and is enabled by default.

• For procedure templates, Enforce Sequentiality can be accessed via the More Options icon (three dots) > Template Configuration Settings. When enabled, the enforce sequentiality feature requires operators to follow a procedure's steps in order.
  • Within each section in a procedure template, procedure authors may set whether that section can be executed in parallel by operators if Enforce Sequentiality is enabled. To enable parallel execution for a specific section, locate the section, then select the More Options icon (three dots) > Enable Parallel Execution.
• For sequentiality within a batch template unit operation, the Enforce Sequentiality setting can be accessed via the More Options icon (three dots) to the right of the unit operation name > Configure Unit Operation. When enabled, the enforce sequentiality feature requires operators to follow the batch unit operations in order.
• For sequentiality across batch template unit operations, the Enforce Sequentiality setting can be accessed via the More Options icon (three dots) icon within the batch run header > Edit Configurations. When enabled, the enforce sequentiality feature requires operators to follow the batch unit operations in order.

Batch authors also have the ability to change the order of batch template unit operations and procedures within a unit operation by clicking the More Options icon (three dots) to the right of the unit operation or procedure name, then selecting the relevant direction to move the item (e.g., "Move right").

For additional information on enforced sequentiality for procedure templates, refer to the Template Configurations Settings section of the Creating a Procedure Template article. For additional information on enforced sequentiality within batch templates, refer to the Creating and Configuring a Batch Template article.

Conditional navigation in procedure execution

Step Navigation, previously handled as an input condition, has been moved to a new Step Navigation section of the augmented step builder. The UI for the step navigation builder has been updated to ease the process of adding a step navigation condition.

Step Navigation allows the procedure author to design a more dynamic flow to step execution, rather than strict adherence to an order from top to bottom. Depending on the conditions added to step navigation, operators may have the option to repeat steps during execution, may be required to repeat steps during execution based on a condition, or may skip one or more steps based on a condition. These conditions can be based on any previously executed input.

For additional information, refer to the Step Navigation section of the Augmented Steps Overview article.

Streamlined and enhanced acceptable conditions for actions and inputs

In order to allow procedure authors to set a more consistent experience around acceptable conditions for actions and inputs, conditions within the system have received a significant refresh, including the following changes:

• Parameter conditions now are set only at the parameter level, not the input level, to avoid duplicative or conflicting conditions
• Replacement of Single and Multiple conditions with new Value(s) condition, where appropriate
• Replacement of Yes/No and Pass/Fail conditions with new Two Choice condition
• Removal of conditions for external resources for material and equipment Resource inputs (as these resources would be managed outside of Tempo)
• Support for multiple conditions for resource inputs (e.g., Class/Subclass/Specific Resource, Alternative Resource, and Usability)
• Support for relevant conditions for Dropdown inputs
• Support for range conditions for Value, Measure, and relevant Parameter inputs
• Enhancements to conditions for Location inputs, including the ability to set "is" or "is in" location conditions, as well as check location usability
• Addition of conditions to Formula actions to match those for Value inputs
• Addition of Specific Resource condition level for material and equipment input conditions, in addition to Class and Subclass.
• Addition of Greater Than or Equal To and Less Than or Equal To conditions for all numeric inputs
• Addition of conditions for Date and Time Capture inputs to validate that the captured date/time falls within process parameters

For additional information about conditions for a specific input or action type, refer to the relevant sections of the Understanding Action Types & Options and Understanding Input Types & Options articles.

Advanced formula functionality

The Formula action has received significant functionality enhancements, including:

• The addition of advanced operands, such as log and root
• The ability to evaluate the formula expression by using simulated values
• The ability to configure default values for inputs or actions that may be skipped during execution, if appropriate

The Date/Time Formula action has also been separated into its own action to allow the procedure author to more intuitively build date/time formulas.

For additional information, refer to the Formula and Date/Time Formula sections of the Understanding Action Types & Options article.

New augmented step actions

The following actions can now be added to procedure templates and executed during procedure or batch runs:

• Material output: Enables procedure authors to guide the operator to consume material quantities during the course of a procedure, record their exact actions and automatically update the inventory accordingly where quantities have been consumed/decremented inside a sublot.
• Consume material: Enables procedure authors to guide the operator to create a new intermediate or output material during the course of a procedure and record their exact actions.
• Dispense: Enables procedure authors to guide the operator to dispense material quantities during the course of a procedure, record their exact actions and automatically update the inventory accordingly.
• Timer: Enables procedure authors to guide the operator to record start and end time and calculate elapsed time, with options for stopwatch and countdown.
  • A new clock icon has been added to the iOS app to allow operators to view active timers.
• Equipment status: Enables procedure authors to guide the operator to change equipment status during execution.
• Create label: Enables procedure authors to guide the operator to define custom label descriptions specifically aligned to material sublots. The material sublot needs to reference another resource action in order to print the related QR code.
  • The iOS app supports printing upon execution as long as the operator's iOS device is set up to support printing using a Labelworks PX LW-PX400 bluetooth printer.

For additional information, refer to the relevant sections of the Understanding Action Types & Options article.

Significant figure guidance for measure input values

Procedure authors must now provide information about the maximum number of integer digits and required number of decimal place digits that an operator will be allowed to provide for manually-entered units of measure. This guides the operator to input number values accurately within the defined specifications.

For additional information, refer to the Measure section of the Understanding Input Types and Options article.

Self-service experience

Tempo v6.3 includes a variety of new features and enhancements that empower supervisors and authors with the information and actions they need.

Batches and procedures

Recipe transfer for batch and procedure templates

To accelerate environment transfers and minimize time spent resolving entry errors, admins and users with appropriate permissions can now move effective batch and procedure templates, including step inputs, across different system environments. The export option is available via the More Options icon (three dots) for batch and procedure templates; the import option is available via the More Options icon (three dots) on the main Batch or Procedure Template page.

A unique hash code that can be copied (for export) and pasted (for imports) is used to transfer the recipe through system transfer. This means that the batch or procedure template does not need to be downloaded to an individual’s computer to make the transfer. Upon export, the unique hash code will be maintained for 7 days before it is expires and a new code would need to be generated to transfer the recipe.

Imported templates maintain version parity when possible. If the destination system already has the same version import, a new version will be created. All new imported templates will have an additional ID marked as "Imported" for import identification.

Upon import, the system will perform a check against existing system objects, such as materials, to either reference the existing material within the new system or create a new material automatically to support the recipe.

Procedure and batch run page updates

Production systems need an intuitive and understandable UI to empower self-service use. With this in mind, a number of enhancements have been made to pages within the procedure and batch run UI:

• Improved the procedure and batch runs pages to make it easier for users to navigate, access, and review the information most important to them. This includes the addition and redesign of multiple tabs (e.g., Steps, Exceptions, BOM/BOE, and Parameters).
• Updated the batch runs page to achieve parity with the procedure runs UI and to make it easier to find the status of a run.
• Updated the batch run page to add a table list view and provide the ability to toggle between list view and scheduling view.
• Reordered the columns on the batch runs page and renamed the Run ID column to Internal ID.

For additional information on procedure runs, refer to the Reviewing a Procedure Run article. For additional information on batch runs, refer to the Reviewing a Batch Run article.

Material inventory allocation

The following enhancements have been made to the batch run BOM/BOE tab:

• Added the ability to allocate one or more inventory sublots per BOM item.
• Added the ability to specify which sublots are “suggested” or “required,” and the quantity per sublot.

Batch template and run page updates

The following enhancements have been made to the batch template and batch run creation experiences:

• The Start Batch Run page (Batches > Runs > Start New Batch Run) has been updated to achieve parity with the Create Batch Template page.
• Helper text and tool tips have been added to both pages.
• Controls have been added to lock fields that should not be changed in various states of a batch run.

For additional information on Batch Templates, refer to the Creating and configuring a batch template article. For additional information on Batch Runs, refer to the Starting a Batch Run article.

Document upload for batch runs

Users with relevant access may now add documents to a batch run. This functionality supports the ability to collect key documentation for a specific batch in one place. Documents can be added at the specific batch run level via the Documents tab and can only be accessed on the Tempo web application.

Procedure and batch templates send back to draft

Procedure and batch authors now have the ability to send a procedure or batch template that is in review back to a draft state. This functionality is available by clicking the lifecycle status widget (In Review), then selecting Send Back to Draft.

Procedure and batch run states (review, hold, and abort)

The following enhancements have been made to the procedure and batch run states:

• Allow a supervisor or quality manager to abort a procedure or batch run or place it on hold. These options are available by clicking the lifecycle status widget for relevant batch or procedure run statuses and allow the user to temporarily or permanently stop a procedure run from moving forward.
• Automatically track and view the current state of a procedure.

For additional information on procedure run states, refer to the Reviewing a Procedure Run article. For additional information on batch runs, refer to the Reviewing a Batch Run article.

Batch run modification setting option

Users with appropriate access in the Tempo web application may now set whether batch run modification is allowed. This setting is available on the specific batch run level via the Batch Run Information tab > Allow Batch Run Modification checkbox and can be updated before a batch is locked and planned.

If Allow Batch Run Modification is enabled, the user can mark a unit operation or procedure as N/A, modify parameter values on Not Started procedures, and insert new procedures.

Improved operator exception experience for iOS

In order to prevent operators from encountering unintentional execution flow blockers that might occur during a batch or procedure run, the Tempo operator experience now includes the following logged user override features:

• Operators can enter the ID of a QR code for resources manually.
• Operators can override sequentiality to proceed to the next step when the current step is not completed.
• Operators can complete a procedure before completing all the steps.
• Operators can recalculate formulas and enter values for uncalculated formulas manually.
• Operators can enter failed integration read or write values manually.
• Operators can override the value of any input or action and display all of the impacted values that are referenced when overriding a specific value.
• Operators can sign for a step before completing all the inputs and actions.

Whenever an operator applies a workaround to continue the process execution, the system enforces the following measures:

• A timestamped log to document the action according to 21 CFR part 11 guidelines.
• The user executing the workaround has the proper level of permission and authentication.
• If applicable, an additional signature is mandated.
• Exceptions are generated to be reviewed by a qualified reviewer.

Material, equipment, and location

CSV export/import

To accelerate environment transfers and minimize time spent resolving entry errors, the following resource lists can now be imported and exported to CSV:

• Materials (including class / subclass and definitions)
• Equipment (including class / subclass and instances)
• Locations
• Statuses
• Inventory (including lots / sublots)

Updated equipment calibration toggle

The equipment calibration toggle has been changed to an optional configuration feature, allowing users to enable only for pieces of equipment that require calibration. When enabled, a Calibration Data tab displays, which tracks equipment calibration data in real-time as part of its overall usability state.

For more information on equipment calibration, refer to the Equipment Instance Overview article.

New event-based equipment triggers

The following event-based triggers have been added to the configuration of equipment classes, which automatically change the status of the equipment in the system after a specified amount of time has passed. Triggers ensure equipment is continuously cleaned, calibrated, and ready for use.

• Timer trigger
• Counter trigger
• Recurring trigger

For more information on event-based triggers, refer to the Creating an Equipment Class article.

Updated subclass requirement

Equipment and material subclasses are now required to be configured in the system. Previously, configuring subclasses was an optional step. This new requirement ensures resource navigation is more manageable by providing granular control and more consistency when defining resources.

For more information on creating equipment and material subclasses, refer to the Creating an Equipment Subclass and Creating a Material Subclass articles.

Setting and locking default values for resource properties

Setting and locking default values is now an option when configuring an equipment or material's standard or custom properties. When default values and properties are set, equipment instances and material definitions inherit those given values. Locking the values then prevents other authors from changing them in the system. If values are not locked, web users with the correct system permissions can override them at the equipment or material's class, subclass, or instance levels.

For more information on default values and resource properties, refer to the Equipment Class & Subclass Overview and Material Class & Subclass Overview articles.

Equipment & material location compatibility

Users can now set on the location unit level whether specific equipment and material instances are compatible with the location. This allows users to enforce that only approved or compatible resources are associated with the unit. During sublot material movement, the system will check to ensure that the sublot is compatible with the location it's being relocated to.

Updated equipment and materials logs

To enable operators with insight into how equipment and materials are being used across the platform, the following logs have been added to the system when configuring equipment instances and material definitions:

• History log: Includes equipment and material creation, deletion, and other updates.
• Usage log: Includes status, calibration data, lot/sublot, procedure, and batch updates.

For more information on history and usage logs for equipment instances and material definitions, refer to the Equipment Instance Overview and Material Definitions Overview articles.

Status stage change requirements

To better support internal and external audits, a new feature has been added that requires operators to provide a PIN, signature, and comment any time an equipment status stage change is made on the web or mobile application. Status stage changes are recorded in the system's logs, which details the name of the operator who made the change, the rationale, timestamp, and more. To review the usage log for a specific resource, navigate to the equipment instance then click the Usage Log tab.

New resource scanning field

A new Scan ID field has been included when configuring equipment instances and material sublots. When an operator scans an equipment instance or material sublot on iOS that includes a Scan ID value, the application now displays the associated sublot or piece of equipment. The Scan ID value is not included for material definitions or regular lots.

Location scanning updates

Scannable QR codes have been added to all location levels in the system (sites, buildings, areas, and units). This change enables authors and operators to:

• Scan location barcodes anywhere in the manufacturing plant to see its current status stages and history logs.
• Scan location barcodes within a procedure being executed.

Standardized lot and sublot language

In order to standardize system nomenclature, all fields that capture or display lot numbers are now called Lot Number, and all fields that capture or display sublot numbers are now called Sublot Number.

System role and user interface (UI) updates

Tempo v6.3 includes a variety of new features and enhancements to enable users to manage roles and access features intuitively within the system.

Updated MES roles

The following MES roles have been introduced to the platform to better support use cases around manufacturing. These role additions provide users with clearer guidance on in-system manufacturing responsibilities.

• System administrator
• External user
• Site administrator - Integration
• Content creator
• Operative
• Quality
• Supervisory
• Executive

For more information on MES roles, refer to the Group Permissions Overview article.

New Group permissions

The way the system provisions security permissions has been remodeled, which allows groups of users to have access to specific sets of MES tasks and responsibilities. To support customer requirements, the system now offers more flexibility around permission assignments: new MES roles, an updated permissions model, and the ability to assign multiple roles and groups.

List of Group changes

• Name change: In the left navigation panel, Teams is now referred to as Groups.
• Remodeled framework: The method in which permissions are provisioned has changed based on a new CRUDA (Create, Read, Update, Assign) framework.
• Group vs. individual user permissions: Users now inherit roles based on the group they are assigned to in the system. More than one role (permission) can be assigned to a group. Roles and permissions are no longer assigned at the individual user level.

For more information on MES groups and permissions, refer to the Group Permissions Overview article.

Navigation panel UI updates

The left-side navigation panel has been updated to include new features and provide access to additional menu options. The navigation panel also groups related features in order to optimize the user experience navigating though the system.

List of menu changes

• The Manuals section has been renamed to Tempo.

  • The link to the Procedure Templates page is now available via Procedures > Templates. (This page was previously available directly via Procedures.)
  • The link to the Procedure Runs page is now available via Procedures > Runs. (This link was previously available in the Business Intelligence section as Procedure Execution.)
  • The link to equipment classes/subclasses is now available via Equipment > Classes/Subclasses. (This page was previously available as an option within Resource Configuration, which has been removed as a menu option.)
  • The link to the Equipment Instances page is now available via Equipment > Equipment Instances. (This page was previously available directly via Equipment.)
  • The link to material classes/subclasses is now available via Materials > Classes/Subclasses. (This page was previously available as an option within Resource Configuration, which has been removed as a menu option.)
  • The link to the Material Definitions page is now available via Materials > Material Definitions. (This page was previously available directly via Materials.)
  • The link to the Exceptions page has been moved to the Tempo section. (This link was previously available in the Business Intelligence section.)

• The Business Intelligence section only displays for relevant system and business administrators and only includes platform logs.

• The Organization section now includes Locations and Statuses as top-level menu options. (These were previously available as options within Resource Configuration, which has been removed as a menu option.)