Spreadsheet Risk Mitigation for Pharmaceutical & Biotech
Pharmaceutical and biotech organizations rely on hundreds and even thousands of complex spreadsheets in manufacturing, development and process areas including analytical chemistry studies, batch release processes, experiments, statistical analysis, and clinical studies. These spreadsheets often contain many external links and data feeds, complex formulas, macros/VB code, hidden data, and advanced mathematical and scientific functions. This complexity easily lends itself to human error, operational risk, non-compliance with corporate and regulatory mandates (e.g. GxP, FDA 21 CFR Part 11) and fraud when these critical spreadsheets are left unmonitored and unmanaged.
To effectively mitigate risk and improve compliance, critical spreadsheets used in pharmaceutical and biotech operations need to be managed with the highest level of integrity and trust throughout their lifecycle. Failure to properly manage and validate these spreadsheets can compromise the integrity of data submitted to the FDA, resulting in non-compliance, increased audit costs and possible regulatory action.
Best Practices for Mitigating Spreadsheet Risk According to spreadsheet validation expert Ludwig Huber, spreadsheet calculations “are electronic records and therefore must comply with FDA’s 21 CFR Part 11” mandates. Huber asserts that “as spreadsheet programs are not designed for regulated environments, special steps must be taken to maintain compliance.” The primary requirements for 21 CFR Part 11 spreadsheet compliance according to Huber break down into 5 key areas, including:
- Use of validated software and computer systems
- User-independent, computer-generated, time-stamped audit trails
- System and data security, data integrity, and confidentiality through limited authorized system access
- Binding electronic or handwritten signatures to electronic records
- Secure retention of accurate and complete electronic records
Enabling Compliance with Prodiance By leveraging technology from Prodiance, the proper spreadsheet and EUC controls to facilitate 21 CFR Part 11 compliance can be embedded into everyday business processes. The Prodiance Enterprise Spreadsheet Manager system is a comprehensive and integrated suite of products designed to help pharmaceutical and biotech organizations automate internal controls over key spreadsheets, Access databases and EUCs that are in scope for 21 CFR Part 11 compliance. The system incorporates industry proven capabilities for discovery, inventory management, risk assessment, management and control, optimization, certification and management reporting.
Ready to Take the Next Step? For an in-depth analysis of how Prodiance enables compliance with 21 CFR Part 11 mandates, we encourage you to download the new white paper entitled Spreadsheets - Mitigating Risk & Improving Data Integrity for Life Sciences from our resource library. You may also like to sign up for an online seminar or contact a Prodiance representative to schedule a personalized product demonstration.