Using Excel Spreadsheets in Pharma can be a powerful resource, but its flexibility and accessibility can also threaten data integrity and compliance in the world of pharmaceuticals.
The application of Excel spreadsheets within the pharmaceutical industry presents a unique set of challenges. This chapter addresses key issues that arise when leveraging this versatile tool for bridging system gaps and creating flexible systems.
One of the inherent strengths of Excel is its accessibility. However, this attribute also constitutes a significant challenge. The ease with which any user can create, modify, and share spreadsheets makes it difficult to establish robust control mechanisms. This results in a proliferation of spreadsheets throughout the organization, leading to potential data integrity and compliance risks if they pertain to a GxP process. Even if the process is not classified as GxP, an incorrect spreadsheet could cause harm to an organization.
While Excel is a powerful tool, it has its technical limitations. Users often encounter challenges related to the precision and accuracy of calculations and difficulties in handling large datasets. These limitations can introduce errors that may go unnoticed, potentially jeopardizing critical decision-making processes.
Excel’s default security features must be revised to safeguard sensitive information, particularly in an industry as regulated as pharmaceuticals. Issues with data protection, including unauthorized access and data breaches, can arise due to inadequate password protection and encryption. This lack of robust security measures may expose valuable intellectual property and compromise patient confidentiality.
Maintaining an accurate and traceable record of data changes and user interactions is a fundamental requirement in pharmaceutical operations. Excel inherently needs a comprehensive audit trail system. This absence hampers the ability to trace the history of data modifications, posing challenges in ensuring data integrity and regulatory compliance.
Compliance with regulatory standards, particularly CFR Part 11, is paramount in the pharmaceutical industry. As a standalone tool, Excel falls short of meeting the stringent requirements outlined in CFR Part 11. This deficiency can impede efforts to achieve and maintain regulatory compliance, potentially resulting in costly penalties and reputational damage.
Despite its widespread adoption, Excel’s true complexity and potential for both innovation and risk mitigation are often underestimated within the pharmaceutical sector. This underestimation, coupled with its endemic usage, can lead to missed opportunities for more robust and compliant solutions.
In conclusion, while Excel spreadsheets serve as valuable tools for bridging system gaps and creating flexible systems in the pharmaceutical industry, their use is not without its challenges. The lack of control, technical limitations, data protection issues, absence of audit trails, and non-compliance with regulatory standards necessitate careful consideration of alternative solutions or supplementary measures to ensure data integrity, security, and compliance within the pharmaceutical domain.
What KVALITO did
To counter the lack of control and oversight, a comprehensive inventory management system was introduced. Excel spreadsheets are categorized based on their department, function, GxP status, and GAMP category. This categorization allows for a more organized approach to spreadsheet management, facilitating identification and tracking. Additionally, the identification of duplicated or similar spreadsheets across multiple sites has been prioritized to streamline operations and minimize redundancy.
To address technical limitations and data integrity concerns, a set of robust design guidelines has been developed. These guidelines provide clear instructions on proper spreadsheet design, including the protection of cells containing critical calculations. Furthermore, efforts have been made to clearly identify input cells and implement data validation mechanisms such as dropdown menus to reduce input errors. Conditional formatting is used to highlight data errors or deviations from specified parameters. User Requirement Specifications (URS) and risk assessments have become integral components of the validation process to ensure data integrity.
In response to inadequate data protection measures and the absence of audit trails, validation and rollout of the tool eInfotree has been implemented. This tool ensures the presence of an audit trail and manages electronic access, enhancing data security and traceability. Additionally, data storage has been transitioned to GxP compliant SharePoint systems with built-in audit trail functionality, versioning, and recovery capabilities.
The challenge of non-compliance with CFR Part 11 has been effectively addressed through a comprehensive validation approach. This validation includes rigorous testing of formulas for accuracy and alignment with existing company documentation, thereby documenting their adherence to validated processes. The resulting validation plan and report ensure transparency and compliance. Versioning and backup storage procedures have been established to safeguard data integrity.
The only avenue to prevent the endemic and indiscriminate usage of Excel spreadsheets is to ensure a proactive approach: mapping business process gaps and training personnel in Excel literacy are essential steps. It is important to remember that Excel spreadsheets can be a compelling and readily available solution for digitalizing processes. Using macros or complex formulas can make Excel spreadsheets close to systems in terms of functionalities. However, it is vital that spreadsheets for GxP usage are created and validated by skilled professionals with the most stringent criteria. Whenever possible, spreadsheets should be replaced with more robust systems, which are often already present within the organization but frequently display gaps that hamper efficient or reliable usage. Any identified gaps within existing systems are incorporated into future releases to improve overall system functionality and compliance.
People, Processes and Tools
People / Roles:
- Business Process Excellence Manager
- Business Analyst
- VBA Developer
- Digital Project Manager
- QA eCompliance
Tools and Technologies:
- MS Excel
- VBA (Visual Basic Application)
- Inventory management through categorization and organization of Excel spreadsheets.
- Improved data integrity with design guidelines, data validation, and risk assessments.
- Enhanced data security and traceability through eInfotree and compliant data storage.
- Comprehensive validation approach for compliance with CFR Part 11.
- A proactive approach emphasizing Excel literacy, skilled professional validation, and system improvement.
- Novartis AAA