Why Paperless Validation Is the Key to Compliance

Paperless validation software can streamline workflows and reduce material use, saving time, money, and the environment

Government regulations keep consumers safe and protect businesses from potential undue litigation. Unfortunately, there may be some additional steps to the workflow. Validating equipment, software, spreadsheets, and other processes can eat up productivity and resources. That's especially true when using traditional paper validation methods. What if there were a better way? Good news: There is. By turning to paperless validation, pharmaceutical companies, medical device companies, and others in similar industries can save not just on the materials needed to conduct validation, but also on the working hours it takes to complete the process.

But that's not all. Paperless validation software can also power greater compliance, facilitate audits, and more. Read on to learn the full suite of advantages of paperless validation.

Ready to ditch paper clutter and embrace a digital workflow? Read this guide to going paperless to learn the benefits of swapping, plus the strategies and tools you need to streamline your work life.

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The challenges of paper validation

There are three stages of validation. They are process design, process qualification, and continued process verification. All three are time and resource intensive. Process verification, however, may be the most time-consuming part. That’s because it must be repeated over and over. The FDA’s Current Good Practices (cGxP) requires mammoth data collection. When data collection happens on paper, it’s vulnerable to mistaken recording. Such mistakes are much harder to catch and correct in physical documents. And as the scale of data collection grows, human error becomes more and more likely. Those errors can cause serious validation problems downstream, such as unexplained deviations within the data.

Validation demands cooperation among many individuals across several teams. This opens the door to communication errors. It also adds lots of time spent simply transporting paper. Finally, all the data must be kept secure and organized. When it’s moving so frequently, both states become hard to guarantee.

Did You Know?:The fi-8170 can scan up to 70 pages per minute and 10,000 pages per day. Click here to learn more.

The benefits of paperless validation

A paperless validation system can solve many of paper validation’s shortcomings. It can also introduce new and useful features. These make validation faster, more efficient, and more secure.

Streamlined workflows

Moving paper documents back and forth between team members is time-consuming and inefficient. They must also be properly stored. When these documents are needed, employees must hope they were filed correctly. If they weren’t, and can’t be located, the missing data may be lost.

With paperless validation software, digital documents travel from worker to worker instantly. They can often be edited simultaneously, boosting productivity. When they’re no longer in active use, storing them correctly takes just a few clicks. Digital documents may be harder to lose or misplace. That’s because they can be indexed and searched using keywords, tags, and metadata. That saves time reproducing lost files. It also may accelerate document retrieval.

Reduced spending on materials

Paper validation is expensive. Supply chain issues and paper shortages drove prices up 6-15% in 2021. And the price of paper is only the beginning. Printer cartridges, file folders, filing cabinets, pens, staplers, staples, and more can eat away at budget. Moving to paperless validation obviates nearly all of these costs. What it doesn’t eliminate, it reduces. It even saves on the square footage needed to store and archive records. That turns file cabinets into productive office space.

Reduced environmental impact

Paper is so ubiquitous, we often forget the effect it has on the environment. It takes 2-13 liters of water to produce a single standard A4 sheet of paper. That’s part of why the pulp and paper industry is the single largest consumer of water in western countries. The United States is the second biggest producer in the world. It also consumes roughly 66,000,000 tons of paper per year. But paper doesn’t just consume water. Its production also pollutes it, and the entire process releases millions of pounds of air pollution yearly.

By switching to paperless validation, you can remove yourself from that negative effect on the environment. You also reduce the overall footprint of the paper industry. Both contribute to a greener planet.

Automated reporting

Paper-based validation requires thousands of human inputs. Finding the right data, recording it correctly, sharing it, and signing off all take time. Each step is a chance for something to go wrong. Each step must be replicated over and over. And each step takes time.

This leads to one of paperless validation software’s great advantages: automation. With paperless validation, your team can set up functions that automatically pull the relevant data for their reports. That accelerates data collection and ensures no errors are made during recording. Automation can also be used to move materials through the validation workflow as soon as they’re ready. That gets data from collection to electronic signature and approval more efficiently.

Boosted audit preparedness

The document delivery troubles that plague paper-based validation grow worse in an audit. Auditors require huge amounts of documentation to perform their jobs. Finding it all in paper systems can take a long time. If it takes too long, your business may fall short of compliance standards. As a result, auditors may levy steep fines.

A paperless validation system gets auditors the data they need takes a fraction of the time. Your entire document archive is just a few inputs away. Many systems can even generate audit trails automatically. These show auditors and inspectors your business has handled all documents with care. No edit goes undocumented, and the process remains transparent from start to finish.

Improved security

Data security throughout the validation process is paramount. With paper, it’s difficult to keep every document within your business’s ecosystem. It’s also hard to keep them safe from bad actors who gain access to storage facilities. If those documents fall into the wrong hands, the data they contain is completely unprotected. Given that the average cost of a healthcare data breach reached $7.1 million in 2020, that risk is not worth taking.

Paperless validation systems combat these vulnerabilities in several ways. User permissions controls help set rules around who can see what data. That prevents unwanted access and contains the fallout from a breach. Data encryption can further limit that fallout. It protects data integrity and prevents bad actors from misusing it. And when 82% of data breaches involve a human element, paperless validation’s automated processes can minimize your exposure.

Did You Know?:ITPro called the fi-7300NX "an impressively comprehensive package" in its five-star review. Click here to read the full review and learn why it received an Editor's Choice award.

Our recommendation: fi Series Scanners

Those in the market for a paperless validation system have no shortage of options, but transitioning from paper to digital requires the right tools. We take great pride in having spent the last 50+ years researching, designing, and developing some of the most advanced and powerful electronics in the world, including our professional grade fi-Series scanners.

Built to purpose for the most demanding document handling jobs, fi scanners are capable of processing tens-of-thousands of pages per day at the highest levels of accuracy. Their intuitive integration capabilities with all existing work suites minimize time-to-value for businesses looking to invest in tools that will pay dividends for years to come.

The fi-7900 provides powerhouse scanning capabilities. It's ultra-fast, scanning up to 140 double-sided pages per minute. Its spacious automatic document feeder can hold up to 500 sheets of paper. Despite that enormous working volume, the fi-7900 has a low-profile design and quiet operation that minimizes disruption in the workplace. Click here to learn more or shop the rest of our production scanner line.

Note: Information and external links are provided for your convenience and for educational purposes only, and shall not be construed, or relied upon, as legal advice. PFU America, Inc. makes no representations about the contents, features, or specifications on such third-party sites, software, and/or offerings (collectively “Third-Party Offerings”) and shall not be responsible for any loss or damage that may arise from your use of such Third-Party Offerings. Please consult with a licensed attorney regarding your specific situation as regulations may be subject to change.