FDA Warning Letters Expose the Risks of Using Paper Logbooks


In the strict pharmaceutical and life sciences industry, keeping detailed records is a regulatory requirement. Accurate and clear documentation of processes is crucial for product quality, patient safety, and regulatory compliance. Unfortunately, many organizations still rely on traditional paper-based logbooks to maintain these critical records.

In this post, we'll look at the risks of using paper logbooks. We'll use real FDA warning letters as examples to show the consequences of improper documentation.

The Fragile Nature of Paper Logbooks

Paper logbooks have weaknesses that can put data integrity and compliance at risk. The physical nature of paper makes it susceptible to damage, loss, or unauthorized alteration. Let's delve into specific examples from the FDA to better understand the risks involved.

February 2022: Missing Pages and Uncontrolled Records

A drug company's quality team got a letter in February 2022 criticizing them for not documenting properly. The FDA cited instances where a batch manufacturing production logbook had missing pages, and numerous batch records lacked the "controlled copy" stamp.

In the company's "unofficial" R&D lab, inspectors found signed and incomplete batch records. Adding to the gravity of the situation, the company had destroyed an API batch record that included crucial manufacturing and analysis records even though the batch was still in distribution.

Key takeaway: Paper logbooks can cause missing or uncontrolled records, making it hard to maintain transparency, traceability, and compliance.

October 2020: Discrepancies and Falsification

After one inspection, an unnamed life sciences company faced grave consequences because of discrepancies in its paper logbooks. The most glaring issue was a cleaning validation sample documented as “received” before it was actually logged.

According to the logbook, the sample was received at 10:50 p.m., while chromatographic analysis showed it was completed around 5:50 p.m. on the same day. Further investigation revealed that the analyst who logged the sample wasn't even in the building when it was recorded.

Key takeaway: Paper logbooks can cause mistakes, intentional or not, that greatly affect the accuracy and reliability of data.

June 2023: Inadequate Recordkeeping

In another instance, an FDA warning letter from June 2023 highlighted the inadequate recordkeeping practices of a pharmaceutical company. Someone carelessly shredded and discarded the cGMP documents, including analytical worksheets, laboratory incident forms, and training records, without proper documentation. The logbook entry for this activity merely stated, "Discard waste papers," providing no meaningful description of the records destroyed.

Key takeaway: This instance highlights the deficiencies of traditional paper logbooks in keeping thorough and clear records, which is crucial for preparedness for audits and adherence to regulations.

What Are the Advantages of Digital Logbook Management?

Paper logbooks are risky because they can have missing records, uncontrolled documents, and poor documentation practices. This can result in compliance problems, penalties, and damage to reputation. To mitigate these risks, forward-thinking life sciences organizations are modernizing their recordkeeping processes with digital tools.

Electronic logbook solutions like ValGenesis e-Logbook offer several advantages over their paper counterparts. They provide a secure, tamper-evident platform for recording and storing data, ensuring data integrity. Real-time data entry, automated scheduling, time-stamped audit trails, and controlled access enhance transparency and accuracy. Additionally, digital logbooks facilitate rapid data retrieval during audits and inspections, eliminating time-consuming searches through physical documents.

This quick look at FDA warning letters should remind us of the risks of using paper logbooks for compliance. Life sciences organizations should consider using digital solutions to protect data, comply with regulations, and avoid expensive mistakes caused by manual recordkeeping.

To learn more about the dangers of using paper-based logbooks and how ValGenesis e-Logbook can help you avoid them, watch the complimentary webinar “How to Manage Logbooks Electronically.”

The opinions, information and conclusions contained within this blog should not be construed as conclusive fact, ValGenesis offering advice, nor as an indication of future results.