A Case Study in the SciCord No-Code Method

Transform Existing Spreadsheets into a Production-Grade System

Benefits

1. Quick implementation and Ease-of-Use for lab personnel
2. Use of existing spreadsheets and processes
3. Enhancements/Upgrades and testing performed quickly
4. Compliance and Validation Materials (Requirements, Risk Assessments, Validation Plans and Reports)

Situation

In May 2022, a customer embarked on plans to optimize their operations, implementing a closed expansion process. The aim of the closed expansion protocol was to enable the simultaneous expansion of multiple products within a single facility, eliminating concerns about cross-contamination through airborne particles. The new process introduced the risk of inadvertent contamination when similar flasks containing different products were present in the same room.

To address this issue, the scientists devised a spreadsheet-based batch record system. This solution not only managed the expansion process but also ensured proper segregation of products. However, it fell short of compliance standards.

---

---

Impact:

The closed expansion process was scheduled to be implemented for production in 2023, necessitating a compliant and robust flask management process.

Outcomes:

This customer joined forces with SciCord to transform their existing spreadsheets into a production-grade batch record system. This transformation involved the development of several modules to digitize all aspects of the process:

---

---

To initiate the batch record development process, the engineers provided SciCord developers with one or more workbooks. The workbooks laid out the process steps and defined the flow of materials and required calculations. The workbooks form the basis of the module and are integrated with LIMS. In a matter of days, the first iteration of a process is implemented (plug and play) in a test environment for review by the engineers. Typically, 2-4 iterations of each module are required to finalize the process. Each module can be developed and ready for documentation and testing in just a few weeks.

“Enhancements/upgrades and testing performed quickly.”

No-Code Configuration turns Spreadsheets into an Opportunity

SciCord provides a platform for an entire research and development organization. Utilize your existing spreadsheets and import existing data for a seamless transition.

Outcome

By recognizing the value of spreadsheets and offering a controlled environment for their integration, SciCord aims to address these challenges and achieve the following outcomes:

• Minimize setup and administrative effort: Implementing the SciCord solution takes weeks instead of months, reducing the time and resources required for deployment.
• Intuitive Interface: Users are already familiar with the spreadsheet interface, which minimizes the learning curve and facilitates ease of use.
• Minimize change management effort: Users tend to prefer spreadsheets and have more control over their data. By embracing spreadsheets instead of fighting them, organizations can reduce resistance to change and facilitate smoother adoption.
• Compliance: The SciCord solution includes validation documentation and ensures compliance with 21CFR Part11 regulations, reducing compliance risks associated with spreadsheet usage.
• Faster Time to Value: Organizations get started quickly with essential features to capture value. Plug and play spreadsheets enable continuous improvement and increase value over time.

Embrace spreadsheets instead of fighting them

SciCord recognizes the value of spreadsheets and offers a controlled environment where they can be integrated compliantly into the organization’s data structure.