Electronic Forms & Checklists Management

Checklyst is a 21 CFR Part 11 compliant software that allows to transform paper-based process into a digital model. It provides functionalities to design, configure and use a customized electronic checklist.

Business Opportunity Positioning for CheckLyst

Several Business Processes are executed with the support of paper based checklist forms containing typically a template of instructions or tasks that need to be executed according to a pre-defined workflow. According to the template, the operator usually acknowledge/confirms the completed tasks, records notes when required during the execution phase and finally signs the template form to confirm the completion of all the activities.

The main risks are related to human errors: wrong inputs or the lack of the inputs at all. To mitigate these risks effort in terms of reviewing  activities is required in order to assure the correct execution and documentation of  the activities. Other complexities are related to cost of control: maintenance, storage and archiving of this paper based forms and very difficult data management and reporting having all this data in paper.

CheckLyst improves business performance and compliance with high value solutions to digitalize paper forms and checklists

CheckLyst Overview

CheckLyst  is a cloud native web application that provides scalability to accommodate increased business needs, offering competitive advantages over traditional solutions. Its microservices architecture is a best practice for building large-scale systems and a prerequisite for performance optimization.

CheckLyst can be configured to manage different plants of the same company (one installation for several plants). Each plant can manage its own users and data independently from other plants (Data Segregation), the date is shown in the company local Time zone format.

CheckLyst can be configured to allow access through network userid and password.
Users of different domains can be configured as users of the same company plant.

Critical Success Factors are:

Solution flexibility and high configuration capabilities

Checklyst manage electronic records and electronic signatures in adherence with the main applicable regulations (such as CFR21 Part 11, EU cGMP Annex 11)
CheckLyst is GMP System validated according to J&J SDLC methodology and currently used in 3 J&J sites.

Increase business performance and compliancel.
Reduce Risks. Discover CheckLyst solutions

CheckLyst System Settings

Users function allows to configure users authorizations. User authorizations can be defined at department and prototype type level.

Audit Trail function allows to access the system Audit Trail where the changes to the system configurations, prototype and instances are tracked

Workflows function allows to configure specific Approval or Retirement Workflows to be used to approve or retire prototypes.

Prototype Types function allows to define the process that has to be managed in CheckLyst for a specific Department (i.e. Cleaning Process for Packaging department)

Departments function allows to define company departments to which the prototype will be linked to.

Data Sources function allows to configure connection with external system.

Increase the digitalization of business process with High Value CheckLyst solution

CheckLyst Prototypes Configuration

The prototype represents the template used to model the set of instructions, the needed inputs and the desired outputs. The design and the approval of a checklist prototype is possible using the Prototype editor.

Prototype Editor consists of two main components:

Users function allows to configure users authorizations. User authorizations can be defined at department and prototype type level.

Audit Trail function allows to access the system Audit Trail where the changes to the system configurations, prototype and instances are tracked

The prototype represents the template used to model the set of instructions, the needed inputs and the desired outputs. The design and the approval of a checklist prototype is possible using the Prototype editor.

It provides functionalities to design,
configure and use a customized electronic checklist

Use Case - CheckLyst New J&J Plant Implementation:

The aim of the project was to improve the managemet of the following GMP critical processess by introducing electronic custom forms in CheckLyst – Checklist Manager solution:

-Cleaning equipment and production line management
-Recipe management
-Label reconciliation
-Line cleaning status check
-Overdue Training Impact Assessment
-Batch record review management

Now, these processes are more robust, controlled and reliable to avoid human errors, unexpected results and critical execption

Solution flexibility and high configuration capabilities

CheckLyst Instances Execution

Once the prototype has been approved the user can create, execute and complete the instance (checklist/form).
Each instance guides the operator in the execution of the activities required by the specific business process (instructions output) and allows the collection of the needed information (user inputs).
The instances can be executed using a standard PC or workstation, in mobility with an iPad and with the support of a touchscreen.

 

During the instance execution the users can confirm steps through 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 after its closure

Our Team

We are proud of our team’s deep experience.
Many of us have worked together closely on prior projects.

Alessia Pezzoli

Co-Founder & CEO

​Degree in Statistical and Economic Sciences awarded in 2003 by University “La Sapienza” of Rome. Co-founder and Partner of Kydea srl Over 15 years of experience as Business Analyst and Project Manager in several projects for Pharmaceutical Companies.

Massimiliano Carosi

Co-Founder & CTO

​Degree in Mathematics in 2001 and the Ph.D. degree in Mathematics in 2007 at the University of Rome “Tor Vergata”. Project and technical manager in many research projects. Over 25 years of experience in software design, data modeling and database analysis and design.

Emanuele Rossi

Devops Leader

​Over 20 years of experience on server platforms, like Windows server, VMware-vSphere, Sun Solaris-Oracle. Expert in network management and system configuration.

Giuseppe Lepparello

Head of Development

​Degree in Mathematics in 2001 at the University of Rome “Tor Vergata”. Co-founder and CEO of Matematici and co-founder of Matematici Ricerca e Sviluppo, innovative start-up. Project and technical manager in many research projects. Over 20 years of experience in software design and database analysis and design.

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