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to design, configure and use 

  a customized Checklist digital model


Features and Function

CheckLyst Multiplant Management

CheckLyst allows to manage different plants  with the same installation. Each plant is a logical workspace where  authorized users can perform and maintain specific plant configurations (system settings  and prototypes) and document processes through digital models, checklists or forms (instances)

CheckLyst Multiplant Management assures:

  • Data Segregation
  • Time zone Management

CheckLyst System Settings

The system settings configuration of each  plant can be easily performed and maintained by users.  Available configuration functionalities are:

  • Users function allows to configure users authorizations. User authorizations can be defined at department and prototype type level
  • Departments function allows to define company  departments to which the prototype will be linked to
  • Prototype Types function allows to define the process that has to be managed in CheckLyst for a specific Department
  • Workflows function allows to configure specific Approval or Retirement Workflows to be used to approve or retire prototypes
  • Data Sources function allows to configure connection with external system
  • FTPs Server function allows to configure FTP service to be used to automatically export PDF files of Prototypes and Instances

CheckLyst Template (Prototype) Building and Configuration

The prototype represents the template used to model the digital process. The design and approval of a prototype is managed  through the Prototype Editor. The Prototype Editor function allows to:

  • Design the business process structure, the hierarchy and the relations between the business operations through a three-level function: 

► Items: Represent the basic operations of a business process

► Groups: Represent a set of operations of a business process with own properties and logic

► Pages: Organization of a set of elementary processes  chronologically or conceptually independent

  • Configure properties of items, groups and pages to design the behaviors of the digital process execution
  • Define the schedule and workflow for the execution of the digital process
  • Define signature and approval steps 
  • Create new prototype by copying or importing an already existing prototype


Prototypes Simulation

CheckLyst provides a simulation environment that allows stakeholders to walk through the process in a step-by-step manner and to check whether the process actually exposes the desired behavior.
The simulation instances are maintained in the system as evidences that the prototype configuration has been tested.

Review and Approval

Users can quickly navigate to prototypes that are available for review and approval. The system automatically notify via email the pending approval action to users with the approval role required by the specific workflow.  Approvers can review the prototype and the related simulation instances. 

The system guarantees that approval sequence configured in the workflow is respected.

The prototype versions are automatically managed by the system (when a new version becomes active the previous one is automatically obsoleted).

Possibility to specify a future activation date.

Approver can reject a prototype and specify a reason for rejection.

Approval is performed with 21 CFR Part 11 compliant electronic signature.

Instance Execution

Once the prototype has been approved the user can start to execute the instances that provide the operation steps foreseen by the digitized process (prototype).  Each instance guides the user in the execution of the activities (instructions output) and allows the collection of the needed information (user inputs).

The system execute automatic checks on the validity of the provided input and on the overall validity of the executed operations.

Specific Exceptions can be raised during the instance execution to allow Review by exception.

The instances can be executed using a standard PC or workstation, in mobility with an iPad and with the support of external devices as touchscreen and barcode readers.

During the instance execution the users can confirm steps through 21 CFR Part 11 compliant Electronic Signature based on network userid and password. Users can also configure a PIN to be used in alternative to the network password.

The PDF of a completed instance can be exported manually or automatically

Audit Trail 

CheckLyst generates an automatic audit trail to track the following system events:

  • Prototypes creation and all changes of state
  • Instances creation and all changes of state
  • Instance signature issue and failure
  • All instance data changes executed during instance execution
  • Workflow signature issue and failure. 
  • All changes to system settings configuration
  • Security related events (failed login, successful login). 

In addition each item of the instance has a specific history table that shows all the changes performed on the specific item.

System architecture

CheckLyst is an application hosted on Microsoft’s Internet Information Services (IIS)
compatible with Google Chrome browser and iOS

Compatible with the HTML 5 standard

CheckLyst has a native cloud architecture infrastructure that can be detailed as follow: 

  • The Frontend level that provides the html/js/css skeleton of the application. A load balancer distributes the requests among all the frontend servers. Each frontend server will be equipped with the frontend MVC application, containing the pages and the client scripts. Each frontend page will use the API provided by the second level
  • The API level contains the API servers. Each API server will be replicated to face scalability issues. A second load balancer will distribute the requests among them. The API servers interfaces with the data level
  • Data level contains a relational cloud database, a key/value pairs persistent cloud cache and a no-sql database