Good manufacturing practices (GMP) regulations require life sciences companies to document equipment usage, cleaning status and other day-to-day manufacturing activities. When manufacturers rely on paper-based logbooks and manual data entry to manage their logging activities, they expose themselves to human errors, poor data integrity, and a host of compliance risks, all of which can result in product quality issues, rework, and even the dreaded FDA Form 483 observations and warning letters. It's simple: Trying to maintain paper-based logbooks in an increasingly digital world is difficult and can be detrimental to your reputation and bottom line.
In a previous webinar, ValGenesis Industry Solutions Consultant Sophia Vraka examined the challenges of using physical logbooks and how a robust electronic logbook management solution can help you avoid them. We’ll discuss three challenges in this post. You can watch the entire webinar.
Challenge: The High Risk of Human Error
Paper-based logbook management involves a lot of human input. And with human input comes human error; it’s inevitable. Handwritten data entry can be incomplete, inaccurate, illegible—or all of the above. This creates enormous GMP compliance issues and makes for stressful audits and inspections.
Even if the data entered is complete, accurate and legible, physical logbooks are easy to misplace or lose in a fire, flood, or other natural disasters. When this happens, employees can spend hours repeating work they’ve already done, increasing production costs and delaying time to market.
A digital logbook management solution like ValGenesis e-Logbook can help you eliminate data entry errors by taking paper out of the logging process. The solution allows users to capture log data in real-time “direct to database,” which is required for compliance. You can even work offline, then automatically synchronize stored information when you’re back online. All information is secured in a unified, compliant cloud repository, simplifying search and retrieval during audits and inspections. Automatic data collection dramatically improves data integrity.
Challenge: Lack of Standardization
One of the biggest challenges in maintaining high-quality data is keeping it consistent across multiple sites and stakeholders. In a paper-based system, it is almost impossible to ensure your logging activities follow a consistent structure and are performed in compliance with required regulations. Poor paper processes lead to poor data quality, which, according to Gartner, is responsible for an average of $15 million in losses every year. (1)
ValGenesis’ digital logbook management solution empowers you to set business rules and automated workflows with pre-defined approval requirements to force standardization and GDP compliance sitewide and companywide. You can also take advantage of time-stamped audit trails, reporting and electronic signatures capabilities to ensure FDA 21 CFR Part 11 and Annex 11 compliance. Without complete, consistent audit trails, you cannot convince regulators that your data is accurate and trustworthy.
Challenge: Productivity Drain
Manual logbook entry requires enormous time and effort because of the sheer volume of information you must document. Staff spend hundreds of hours generating, reviewing, and approving logs. And because paper logbooks are typically stored offsite, they may spend many more hours retrieving the information from massive data warehouses filled to the brim with documents.
Happy workers and productivity go hand in hand; most don’t want to spend their workday toiling through repetitive, non-value-added tasks which could easily be automated—or rummaging through binders and boxes. Manual logbook management is frustrating and takes a severe toll on individual and organizational productivity.
A digital logbook management solution can add hours to an employee’s workday, allowing them to focus on value-added tasks that contribute to your company’s bottom line. The ability to access log records quickly can lead to more successful audits and inspections which, in turn, may help you avoid FDA Form 483s and hefty fines.
If you’re reading this blog, there is a good chance you’re familiar with the term FDA Form 483; however, if you’re not familiar with the term, the FDA website is an excellent resource. In short, an FDA Form 483 or “inspectional observation” is a notice a company receives that highlights any potential regulatory violations found by FDA inspectors during a routine inspection. (2) In a future post, we’ll examine commonly issued FDA Form 483 observations tied to poor logbook practices.
To learn more about the challenges of paper-based logbook management and how an effective digital solution like ValGenesis e-Logbook helps you meet those challenges head-on, watch the webinar “How to Manage Logbooks Electronically”.
- S. Moore, “How to Create a Business Case for Data Quality Improvement”, Gartner.com. Accessed on June 18, 2018.
- “FDA Form 483 Frequently Asked Questions”, fda.gov. Accessed on January 9, 2020.