SciCord

A Case Study in the SciCord No-Code Method

A Life Science Company Transforms 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 prominent pharma lab within a large multifocus enterprise, operating in the biotech/manufacturing sector, faced a pivotal challenge. Tasked with integrating their highly specialized process — controlled expansion of multiple products to eliminate the possibility of cross-contamination — the lab relied on paper notebooks and spreadsheets. However, this approach fell short of meeting stringent compliance requirements, including Good Manufacturing Practices (GMP), product registration, and adverse event reporting.

The lab’s primary goals were clear: to meet compliance requirements and fully capture their spreadsheet-based process within an Electronic Laboratory Notebook (ELN)/front-end system. Despite using spreadsheet-based protocols and records for risk mitigation, they realized the need for a solution that would seamlessly integrate their existing processes while ensuring regulatory compliance.

Within this regulatory environment, compliance was paramount. Meeting these standards was not only essential for obtaining regulatory approval but also crucial for maintaining public trust and avoiding penalties such as fines, product recalls, and legal actions.

The lab sought a solution that would enable them to meet all compliance requirements without the need to rebuild their current processes around a Laboratory Information Management System (LIMS)/ELN.

Challenges

  1. Reliance on paper notebooks and spreadsheets for data/process management
  2. Need to integrate highly specialized process captured by spreadsheets with compliance requirements
  3. Desire to meet compliance requirements without overhauling current processes around a LIMS/ELN

Legacy Cell Culture Workflow:

Challenges of Manual Documentation and Disjointed Data Management in the Absence of LIMS/ELN Integration


Impact:

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

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.”

Streamlined Cell Culture Workflow:

Integrating LIMS/ELN Solutions to Enhance Efficiency, Traceability, and Compliance


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.

The Challenges for
Eliminating Spreadsheets


Spreadsheets are a pervasive presence within most organizations, often housing vital information even after the implementation of applications like LIMS and ELN. Spreadsheet flexibility, functionality, and compatibility with scientific data and processes make them a natural choice for scientists.

The Impact of Continuing
to Use Spreadsheets


Without proper control and management, spreadsheets can lead to compliance issues and impede effective data visualization/analysis. Ultimately spreadsheets can negatively impact decision-making processes within an organization.

The SciCord Solution


An all-in-one Informatics Platform that can be implemented in weeks instead of months. Integrate your existing spreadsheets, integrate them fully with the rest of your system and data, and unlock additional trending and reporting opportunities with minimal time invested.

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.

Functionality

  • Spreadsheet toolset provides Streamlined layouts, formats, and process flows. Efficient data entry, lists, calculations, and more.
  • Compliance with CFR21 Part11 records and signature requirements
  • Template and document control

Advantages

  • No code configuration
  • Excel’s knowledge base
  • Work process which makes sense

Benefits

  • Accelerate implementation
  • Reduce administrative overhead
  • Manage existing spreadsheets
  • Utilize staff expertise
  • Intuitive Interface

More From SciCord


Case
Studies

Case Studies

Formulated Solutions Achieves Operational Excellence with LIMS Implementation

Formulated Solutions streamlined operations and reduced costs by of $360,000 per year

Read More

Pearl Therapeutics’ Regulatory Triumph through Implementation of ELN and LIMS

With SciCord LIMS/ELN, Pearl Therapeutics improved review process efficiency by over 30%

Read More

Aurobindo Utilizes SciCord Platform for Successful FDA Filing

FDA audit issues can cost millions of dollars - Aurobindo has relied on SciCord to avoid FDA issues twice

Read More

Trusted by Organizations of All Sizes



Contact
Us

Reach out to Schedule a Meeting and get more information about how SciCord can fit into your lab

What Our
Users Say

Don’t take our word for it.
We exceed our client’s demands everyday to make their research and discovery process simpler and more efficient.

This is by far the best value in science software (or anything else in science, really) that we’ve ever experienced. Other solutions in this price range had a fraction of the features, and those with the features cost 3x – 10x more. We’re very happy customers.


Josh Guyer,
Senior Pharmaceutical Scientist



  

All product names, logos, brands and trademarks are property of their respective owners. All company, product and service names used in this web site are for identification purposes only.
Use of these names, logos, brands and trademarks does not imply endorsement or direct affiliation with SciCord, LLC.

The information contained herein is on an “as is” basis, without warranties or conditions of any kind, either express or implied, including, without limitation, any warranties or conditions of title, non-infringement, merchantability, or fitness for a particular purpose.
You agree that you will not rely on and are solely responsible for determining the appropriateness of using the information provided on this web site and assume any risks associated with doing so.



Copyright © 2012-current year SciCord LLC All Rights Reserved.