How paperless validation with a commonsense approach can solve these problems. It’s not heavy on technical explanations or regulatory rationale, although we’d be happy to discuss this with you directly. Rather, this blog sheds light on what we’re actually dealing with and why paperless validation is now considered preferred best practice.

In a 2016 Xerox study, 80 percent of companies want to create paperless processes and workflows … the Sierra Club [and] Reduce.org, … [say] the average office employee [generates] 10,000 sheets of paper per year …equivalent to one tree [costing] an estimated $725 USD. … according to RecordNations.com, 45% of that paper winds up in the trash.

Paperless Validation is the same, but better

Paperless validation is the same as paper-based validation. The regulation (21 CFR Part 11) hasn’t changed since 1997. Systems must still be validated. Ironically, the basis for Part 11 was to allow electronic records and electronic signatures. Note that the regulation is not electronic documents/eSigs.  It’s electronic records. Yet, as an industry, we’re not leveraging the power of technology and how it can manage data as records, like most other industries. Our industry is slow to adopt technological advances because of patient safety concerns; that, and the old that’s the way we’ve always done it motto.

One must ask, is slowing technological advancement really improving patient safety, or jeopardizing it? Of course, you don’t want to advance so quickly that you’re using bleeding edge technology. It’s called “bleeding” for a reason. Neither do you want to be lethargic like a sloth and move so slow that algae grows. No doubt you want to be advanced to survive, and help patients survive, too.

Paperless validation advances you to the next logical progression of the validation evolution.

The Plight of Paper

With paperless validation, you’re not killing trees printing mountains of documents, punching three-holes and putting them in binders, only to be stored in a document archive that is only accessed during an audit or inspection; or if you need to refresh your memory by reading said monolithic paper mountains. Rather, paperless validation, well, doesn’t require paper.

Have you ever calculated how much you spend on a paper document archive? You may be surprised when you sum up the cost of square footage, buildout, and resources to maintain it all.

Historically we found ourselves with a false sense of security thinking the amount of paper generated must signify the effort and diligence put into validation. With this thinking, a six-foot stack of documents must be twice as good as a three-foot stack. A seasoned auditor, or inspector, knows this isn’t necessarily true. In fact, the challenge of maintaining templates, formatting, standards, redlining, collating comments and feedback, all of this, is prone to human error. The more manual it is the more human it is. In fact, the more laborious and tedious the task, the more likely corners will be cut, loopholes sought out, and sheer boredom and mind-wandering will occur. With a few rare exceptions, the human brain isn’t designed to sift through data. That’s the beauty of computer systems. They’re designed with data in mind. They never get bored. They’re consistent. And they move at the speed of electricity; in some cases, the speed of light where fiber optic technology is used.

Paper-less is More

As stated before, with paperless validation you’re still validating systems as required by regulation, and it’s okay to use electronic records. It’s been okay since 1997 with Part 11 and subsequently EU’s Annex 11. But paperless validation is so much more than just “no paper”.

Paperless validation is leveraging technology to improve efficiency and quality. To go paperless, you must digitize. This means you need a computer system because computers use digits to store data, not paper. You can produce paper if you need or want to. Just like you can print a document from MS Word or Excel. Isn’t it interesting we use technology to produce paper when, in fact, we don’t need to print pages because:

  1. It’s less efficient as more effort is required after you print it (3-hole punch, collate, put in binder, and file in archive).
  2. Once printed it requires humans to re-read the pages to make sense of the information.
  3. Only one person-at-a-time can be reviewing, unless you make a copy, and this raises even more concerns.
  4. It’s not backed up, so, if you lose it, then even more effort is needed to attempt to re-create.

Conversely, paperless validation is:

  1. More efficient because less effort is required after you record the data, records, and information.
  2. Technology can be leveraged to find, sort, analyze and trend the data, in a matter of minutes, with human error significantly reduced.
  3. Any authorized individual can immediately access the information simultaneously. In fact, you can divide and conquer with follow the sun validation, allowing teams of people around the world the ability to work together and get the job done.
  4. Good paperless systems are backed up, predominately stored in a cloud with high availability, fault tolerance, immediate fail over to disperse geographic locations in the event of a disaster. Basically, your disaster recovery and business continuity issues are resolved with paperless validation.

Technical Controls don’t have Opinions

When it comes to procedural controls, humans are the problem. We’re required to read and understand a procedure and we sign-off that we’ve read and understood. But did we really read and understand? Even if we did, how long before we start to forget some of the details? Or did we misunderstand, thinking we correctly understood? And is our opinion of the procedure going to influence our actual work? We may reason, they really didn’t mean that, they actually meant this. This recursive reasoning is one of the things that sets humans apart from other species. Animals will repeat what they’ve learned over and over. But we humans improvise. We find better ways to accomplish the same thing, so we think.

Technical controls help us humans do thinks consistently, over and over, exactly the way it was intended, following the process without taking shortcuts. With paper-based validation, reliance on procedural controls is the way it’s done. Our work is reviewed and verified by others with their own “opinions” about the procedure. Sometimes there’s friction, other times there’s acquiescence just to get things signed off. Technical controls in paperless validation avoid all of this frustration by having the right individuals approve the technical control, and validate it, before it is deployed. Then at the time of review, those that are signing off know that the process was followed because that’s the only way a person could get to that point (i.e., by correctly following the procedure as governed by technical controls). And last but not least is technical controls can ensure consistency and enforce compliance. Not so with manual procedural controls, which often finds issues after the fact when the damage may already have been done.

Don’t Go Paperless, Yet

Before running out and buying a paperless validation system, it’s important to get answers to the following questions:

  1. Do you have commitment from the top?
  2. Do you have buy-in from all key stakeholders?
  3. Is there money in the budget?
  4. Do you have a timeline when to implement a paperless validation system?
  5. Is your organization’s culture capable of embracing change?
  6. Do you realize there’s a problem with manual paper-based validation?
  7. Do you know how to find the right paperless validation solution provider to partner with?

Would you hire someone to build you a house if they say they can do it, or would you rather have an experienced professional who has delivered homes to many happy customers that are real people who actually live in those homes?

As for questions 1 – 6, you can find the answers within your organization. Regarding question 7, here are a few points to consider:

  • There’s a big difference between those that say they can do it versus those that are doing it. In other words, a “can do” attitude is nice, but not the same as “done it”.
  • Has the vendor proven themselves as evidenced by company stability, longevity, market share, and proven domain expertise in life science?
  • Has the vendor’s solution withstood auditor scrutiny and is proven defensible for a regulatory inspection?
  • Does the vendor provide an infrastructure that is reliable (at least 99.999% uptime) and scalable, elastic, and dynamic, allowing you to change size and scope in both depth and breadth as validation needs change?
  • Does the vendor have unique features and functions that only they provide?

As stated at the beginning of this blog, it’s not heavy on technical explanations or regulatory rationale, but we’d love the opportunity to shed light on these areas. We’re confident you’ll be happy with the results. ValGenesis is the pioneer of paperless validation establishing itself as the market leader with an unmatched customer base and global reach. Proven technology that some of the biggest life science companies rely upon, yet also able to meet the needs of a start-up that’s bracing for rapid growth.

Contact us today so we can discuss your needs and help guide you to success. We want to hear your answers to questions 1 – 6 above and meet your team. We also want to give you comfort with question 7.  We’ll also shed light on the 5 bullet points just listed.

We look forward to hearing from you today.

[1] “Are Companies Succeeding at going Paperless?”, Mike Roaia, Integrify.com

About the Author

Steve Thompson

Director Industry Solutions of ValGenesis

Steve has worked in the life science industry for over 20 years and has experience working for Fortune 50 and start-up pharma, biotech, and medical device companies. As Director of Industry Solutions for ValGenesis, Inc., he helps the life science customers realize the benefits of applied advanced technologies. He is knowledgeable of internal and domestic GxP regulations, was certified as a Parenteral Drug Association auditor and has audited hundreds of companies globally. He’s on the Editorial Advisory Board for the Institute of Validation Technology (IVT), faculty member for Knowledge Exchange Network (KENX), a published author and frequent speaker at conferences

Be the first to write a comment.

Leave a Comment

You must be logged in to post a comment.