This article highlights the limitations of Excel as a process management tool and the challenges that arise as process complexity increases. We explain why Excel is often useful in the early stages of smaller projects but quickly reaches its limits as processes become more complex and involve more stakeholders. Additionally, you'll learn when it's time to switch to specialized solutions and the benefits they offer for efficient and secure process management.

Why are so many process management solutions implemented in Excel, and why does this often make sense at the beginning?

Excel is one of the most flexible and widely used tools in everyday work. It's easy to get started, the software is widely available, and users can quickly create spreadsheets, collect data, and map out initial process flows. Especially in the early phases of new projects or with smaller teams that want to start without significant IT effort, Excel is the obvious choice. Its ease of use and the ability to utilize formulas and macros make it a "Swiss Army knife."

For manageable and less complex processes, Excel can indeed be efficient: simple to-do lists, data collections, and workflow documentation can be quickly implemented and adapted. However, what initially appears as a pragmatic solution often becomes problematic as process complexity increases.

What happens as the complexity of processes and the number of participants increase?

As processes grow in size and complexity, the limitations of Excel become increasingly evident, as it was not initially intended for process management. When multiple departments, larger data volumes, and intricate dependencies are involved, common issues quickly emerge:

Lack of Transparency: Excel does not provide versioning of individual records, tables, and sheets separately nor a version history. It is often impossible to trace who made which changes. Additionally, it is not feasible to provide written justifications for changes, track user roles, validate entries either automatically or manually, or revert individual changes without resetting the entire document.

Collaboration Issues: Simultaneous editing of an Excel document can lead to problems, such as overwriting data and results from others. Issues with synchronization or duplicate entries are also possible.

Limited Automation: Although Excel supports macros and formulas, these approaches are unscalable and difficult to maintain compared to specialized tools. Additionally, Office macros should be avoided due to potential IT security risks, such as the possibility of introducing malware, unauthorized access to sensitive data, and vulnerabilities that can be exploited by cyber attackers.

Inadequate Security Standards: The access restrictions and permission concepts of Excel are limited, leading to potential security vulnerabilities.

In short, with increasing process complexity and more participants, Excel reaches its limits and quickly becomes a cumbersome, error-prone, and time-consuming solution. The supposed efficiency gain turns into an effort that hinders rather than supports the process.

When is it beneficial to explore alternative tools beyond Excel?

The right time for a replacement is when Excel is perceived not as an aid but as a hurdle. Typical signs include:

• High Manual Effort: When data maintenance and error correction consume more and more time.
• Loss of Data Integrity: When there are repeated instances of data loss or erroneous calculations.
• Lack of Scalability: When the Excel model can no longer efficiently handle growing data volumes (usually from 20,000 entries, depending on the version and hardware).
• Missing Functionalities: New requirements come up which cannot be implemented in Excel, such as role and permission concepts, approval workflows for certain entries, escalation levels, or the need for an audit trail.

Excel is not designed as a central process management tool. As soon as processes require more functionality, automated workflows, or complex approval and permission structures, it makes sense to switch to a specialized tool or a modern cloud solution.

What added value can a specialized tool provide?

The use of specialized tools offers many advantages, the most important being:

Real-time Collaboration: In Excel, version conflicts quickly arise when multiple people work on a file simultaneously. Tailored software solutions, on the other hand, enable real-time collaboration, allowing teams to access the latest version without version issues. Automated maintenance of an audit trail is also possible.

Enhanced Data Security: Modern applications rely on advanced encryption methods and offer protection mechanisms against unauthorized access, data loss, or cyberattacks. Regular security updates and redundant backup systems ensure a high level of data integrity.

Mapping of Workflows, Roles, and Permissions: The manual definition and training of processes can be time-consuming and error-prone. Software solutions, however, allow for clear and precise mapping of processes as well as the assignment of roles and permissions directly within the application. This not only reduces training efforts for employees but also minimizes the risk of misunderstandings and errors. Additionally, modern software solutions provide input assistance and validations to ensure that only correct and complete entries are submitted.

An illustrative case involves a software solution we developed for a client in response to their specific requirements. For the verification and release testing of raw materials, intermediate materials and active pharmaceutical ingredients (APIs) in quality control, it is essential to have valid testing protocols alongside the corresponding analytical methods and test parameters as integral components of the validation master plan (VMP). These documents must be version-controlled and regularly reviewed to ensure that each batch release is executed using the appropriate methods and parameters.

Initially, our client managed this critical data using an Excel spreadsheet that had expanded over time to include more than four thousand entries at the project's inception. For biannual regulatory submissions, the data required manual formatting to comply with agency guidelines. A change control log, maintained in a separate spreadsheet, was also included in the submission package. During the multi-day reporting period, routine operations had to be temporarily suspended. Regular processing involved identifying specific entries upon receipt of emails and cross-referencing them with the Laboratory Information Management System (LIMS). Any identified discrepancies were rectified and documented in the change control log. Additionally, several hundred other Excel files were consulted for data evaluation.

Following a comprehensive collaborative assessment of the current workflow, we evaluated with the client the feasibility of utilizing an existing or commercially available solution. Due to the highly specialized nature of their requirements and processes, the client decided to pursue a custom development. We designed and implemented a tailored solution that streamlines the client's daily operations. Leveraging a robust data model, records are now easily accessible, and data entry can occur seamlessly without the need to toggle between multiple files. The automation of change control documentation has also been integrated, along with connections to all relevant third-party systems. As a result, the effort of generating reports has been reduced from several days to just a few minutes.

INCONSULT: Specialized Process Management Solutions

Through our many years of experience in the life sciences and pharmaceutical industry, INCONSULT is able to analyze, understand, and uncover optimization potentials in complex processes that have developed over time through incremental, ad-hoc solutions and have become increasingly confusing. Based on this, we design and develop modern, customer-specific solutions, taking into account regulatory and industry-specific requirements, and migrate the existing information into the new solution. We rely on modern cloud technologies and proven frameworks to ensure a stable and secure solution. We also consider the operation and further development of the application, with automated installation processes and an organized codebase ensuring a seamless lifecycle. This ensures our quality standards.

We develop solutions with modern cloud technologies, as they offer significant advantages. Especially in the areas of data security, compliance, and user management, cloud platforms are decisively superior. Important topics for us include:

• High Data Security: Cloud applications rely on advanced encryption methods and offer protection mechanisms against unauthorized access, data loss, or cyberattacks. Regular security updates and redundant backup systems ensure a high level of data integrity.
• Compliance with Data Protection Requirements: Cloud services are often specifically designed to comply with strict legal requirements, such as GDPR or industry-specific regulations. Providers offer certifications and audit reports to ensure that your data is processed and stored in accordance with applicable regulations.
• Enhanced User Management and Permission Concepts: Cloud solutions allow for detailed control over who can access which data and functions. With role-based permissions and single sign-on (SSO), you can ensure that only authorized individuals can view or edit certain information.
• Support for Regulatory Requirements (GxP): The pharmaceutical industry is subject to strict regulations. Cloud platforms can assist with audit functions and versioning to provide the required evidence and meet legal requirements without difficulty.

Through extensive expertise in software development and the design of solution architectures, we ensure that our clients benefit in the long term from working with INCONSULT. Our guiding principles for project execution are reliability, security, cost optimization, operational excellence, performance efficiency, and sustainability.

Conclusion

Utilizing Excel for managing business processes can be effective during the initial stages; however, it soon encounters limitations as process complexity and participant numbers grow. Challenges such as a lack of transparency, data inconsistencies, and inadequate automation highlight the need for specialized tools to achieve effective process management.

If you are looking to enhance the efficiency of your processes, we would be glad to share information about our services and cloud solutions. Reach out to us to discuss your requirements and discover how we can assist you.