The Pitfalls of Paper Forms in Pharmaceutical Manufacturing
Paper documentation and wet signatures are still all too common in manufacturing operations. At this point, the pitfalls of paper forms outweigh their benefits. This is why many pharmaceutical companies are turning to digital solutions to streamline their processes, reduce paperwork, and make their operations more efficient.
With electronic forms, users can securely document their activities and access information and documents in real-time via secure online portals. Electronic forms eliminate the need for lengthy paperwork at risk of loss, damage, or incorrect entry. Let’s look at the top pitfalls of paper forms and why it’s time for pharmaceutical manufacturing companies to switch to digital solutions for electronic work instructions, logbooks, and records.
The Top Pitfalls of Paper Forms
If you’re an operator, a supervisor, or a production engineer in the pharmaceutical industry, you’ve probably experienced the frustration of filling out paperwork. Here, we will discuss the problems of using paper forms for following work instructions and manufacturing activities.
1. GxP Errors and Observations
Papers and errors are old-time pals that we can’t separate. Eliminating errors is critical to complaint with good practices (GxP). The quality of the final product is closely tied to the quality of the documentation used to produce the product!
Since GxP is all about safety, paper forms can’t be trusted to guarantee the four good practices; GMP (Good Manufacturing Practice), GDP (Good Documentation Practice), GLP (Good Laboratory Practice), and GCP (Good Clinical Practice).
Common paper errors relating to the four GxP are illegible handwriting, failure to use indelible ink, etc. These can lead to unclear guided work instructions and big errors in pharmaceutical procedures.
2. Physical Presence Required for Wet Signatures
All employees in a pharmaceutical company are required to wet-sign on a signature register. However, doing this requires the physical presence of the user, operator, supervisor, or review. This is too long a process, since waiting on an employee to arrive and sign can impact production timelines.
3. Lost and Damaged Paper
Paper records like logbooks, signature registers, etc., are prone to damage after they get old as they do not have long life spans.
To cap it all, they could go missing. For example, if an SOP page (Standard Operating Procedures) tears, it can get lost easily. Likewise, record papers that are just a sheet or a few can be misplaced, as they have no weight. As a result, employees will have limited information about pharmaceutical procedures, which will, in turn, disrupt workflows.
4. No Way to Track and Trend Collected Information
Data collection with paper is tedious. It also does not allow easy data tracking or studying data trends. Electronic forms and electronic workflows allow you to capture data, monitor the changes in received information, and categorize them for analysis.
Even though it can be used for data collection and the data can be analyzed after that, its functions are still limited.
5. Incomplete or Inaccurate Data Input
Pharmaceutical employees sometimes might be constrained from giving full information due to limited paper space. Inaccurate data input could also occur because of poor form designs, abbreviations, and entering data in the wrong fields.
When there are errors in data input, it might be hard for employees to notice since there is no automated error message to alert them.
6. High Cost and Storing Inefficiencies
Printing paper-based forms all the time can be expensive. Storing bulky amounts of files also consumes a large space.
7. Not Easily Retrievable
Going through huge files to retrieve old logging records, supply information, number of production batches, and prescriptions is always not possible. Retrieving those data could require a great amount of time and could be stressful.
Why must Pharmaceutical Manufacturers use eForm Solutions?
Filling paper forms is usually tedious and lengthy. They require you to constantly refer back to the original document. This can be cumbersome during the release process in which all paper forms and records must be reviewed.
To make matters worse, filling out paperwork can be time consuming as well. The more special instructions you have to follow, the more likely you’ll spend more time completing each form than necessary.
Regardless, the only way to overcome these issues is using the electronic form or workflow solution. This means pharmaceutical, biotech, life sciences, and cell & gene manufacturers must switch to using electronic forms to manage workflows (electronic workflows) and give work instructions. Furthermore, It saves time and aids the accurate data collection process. The automation feature saves you the headache that manual work procedures involve.
If you want to adopt electronic forms in your pharmaceutical manufacturing company, we can walk you through the steps. We will replace your paper records and numerous spreadsheets with OpsTrakker electronic solutions. OpsTrakker is a trusted manufacturing solution to replace all paper records, forms, logbooks, and work instructions with a mobile solution. The solution is fully compliant with good manufacturing regulations such as US FDA 21 CFR Part 11 and EU Annex 11. This will give you access to your workflow data and assist you with compliance and productivity.