The Truth about Managing Design Controls on Spreadsheets

Design controls are an essential part of the product development process, ensuring that products meet regulatory requirements and are safe for use. However, managing design controls can be a complex and time-consuming task, especially when using spreadsheets as a tool. In this article, we will explore the truth about managing design controls on spreadsheets and discuss the challenges and potential risks associated with this approach.

Spreadsheets have long been a popular choice for managing data and calculations due to their flexibility and ease of use. Many companies rely on spreadsheets to track and document design control activities, such as design inputs, design outputs, verification and validation activities, and risk management. While spreadsheets can be a convenient tool for small-scale projects or simple tasks, they may not be the most suitable option for managing design controls in a regulated environment.

One of the main challenges of using spreadsheets for design control management is the lack of version control and traceability. As design control activities progress, multiple versions of spreadsheets may be created, making it difficult to track changes and ensure that the latest information is being used. This can lead to confusion, errors, and inconsistencies in the design control documentation.

Another issue with spreadsheets is the limited ability to enforce data integrity and validation. Unlike dedicated design control software, spreadsheets do not have built-in validation rules or data integrity checks. This means that users can easily input incorrect or incomplete information without any warning or error messages. As a result, critical design control information may be compromised, leading to compliance issues and potential safety risks.

Furthermore, spreadsheets lack the ability to provide real-time collaboration and visibility. In a team-based environment, multiple stakeholders may need to access and update design control information simultaneously. Spreadsheets often require manual sharing and merging of files, which can be time-consuming and prone to errors. This lack of real-time collaboration can hinder effective communication and coordination among team members, leading to delays in decision-making and project progress.

In addition to these challenges, spreadsheets may not meet the documentation and audit trail requirements set by regulatory bodies. Regulatory agencies, such as the Food and Drug Administration (FDA) in the United States, require companies to maintain accurate and complete records of design control activities. Spreadsheets may not provide the necessary level of documentation and audit trail, making it difficult to demonstrate compliance during regulatory inspections or audits.

To overcome these challenges and mitigate the risks associated with managing design controls on spreadsheets, companies should consider adopting dedicated design control software. Design control software offers features specifically designed to address the complexities of managing design controls in a regulated environment. These features include version control, traceability, data validation, real-time collaboration, and comprehensive documentation capabilities.

By using dedicated design control software, companies can ensure data integrity, improve collaboration and visibility, streamline documentation processes, and enhance compliance with regulatory requirements. While there may be an initial investment in implementing such software, the long-term benefits in terms of efficiency, accuracy, and regulatory compliance outweigh the costs.

In conclusion, while spreadsheets may seem like a convenient tool for managing design controls, they come with inherent limitations and potential risks. To effectively manage design controls in a regulated environment, companies should consider adopting dedicated design control software that offers robust features and capabilities. By doing so, companies can ensure compliance, reduce errors, and streamline their product development processes.

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• Source: Plato Data Intelligence.
• Source Link: https://platohealth.ai/managing-design-controls-on-spreadsheets-the-ugly-truth/