As previously discussed in my earlier blog post on “What is paperless validation in the pharmaceutical industry”, we looked at the driver for a paperless validation solution within an organisation that brought attention to the struggles of a paper-based approach. In this post, let me share with you what I think are the top 7 reasons why pharmaceutical companies need paperless validation.
1. Reduced costs
The most obvious cost that one could think of is the stationery cost – the papers, the binders, the shelves, the pens, and the list goes on. However, beyond the direct cost of stationery, one will need to also consider the cost of archival at a remote facility, document controller(s), and climate-controlled storage space for the documents, just to name a few. The costs at various stages of paper-based implementation and maintaining the records add up quickly. This is especially true for regulated industries such as pharmaceuticals where a defined retention period is mandated. Paperless validation, while not eliminating the costs associated with documentation works, does however reduce the costs associated with the paper-based practice.
2. Reduced document storage space
Often, we encounter rows and rows of document compactors installed in the document control room to securely store the validation-related documents. It is a rather difficult task to estimate, even at the design stage, how many compactors are required and/or how big the document control room needs to be. With paperless validation, the executed documents are stored securely in a web server such as Amazon Web Services, freeing up valuable real estate for plant use.
3. Elimination of the “who has the document” question
This could be the most asked question when unable to find a document binder in the document control room after flipping through the check-in check-out log. I am sure many of you readers have an experience or two to relate to what I am describing. With paperless validation, the executed documents are always there. One will need to use the search function, as you would with any other electronic Document Management System (EDMS) to find related documents.
4. Elimination of “miscommunication” due to document versions
It is almost impossible for a solo effort in performing qualification/validation activities. There are the document preparation discussions, reviews, approvals BEFORE and AFTER execution. From personal experience, the first opening query when reviewing a document in the preparation step is asking, “What version were you working on?”. As you can imagine, this is most certainly due to sending working files through emails, less-than-ideal governed SharePoint etc. With the paperless validation solution, all the stakeholders are working in real time on the same document, essentially eliminating the notion, “Sorry, I was referring to a wrong version.”
Book an informative introductory 15-minute call with JoonLeong to clarify your CQV / Kneat / Paperless validation requirements and to understand how we can support you.
5. Elimination of “grandfather-ing” errors in documents
Whenever tasked with drafting an execution protocol in a paper-based system, it’s almost intuitive for the author to be retrieving from a repository, what is deemed as the greatest and latest version of the protocol related to the task at hand. While this has generally worked, one will need to consider the notorious formatting errors that copy over, the required changes that were not picked up by ctrl-F, the outdated acceptance criteria, etc. Further consideration may also need to be given to the rigour of the review process and the time needed if every document is drafted from the notion of “latest and greatest”.
With paperless validation, harmonisation is achieved through properly thought-out governance using templates. These templates could be the document templates or the elements that could be used to particularise the document templates. The templates would be version controlled and updated only by a select few to ensure consistency and accuracy of information at its latest.
6. Reduced “panic attack” during audit preparedness
One of the many reasons for the nervousness of auditees is getting hold of the requested documents swiftly and ensuring that the content meets the auditors’ expectations. With a 21 CFR Part 11 compliant and Good Documentation Practices (GDP) inherently built into a paperless validation solution such as Kneat, the audited organisation can rest assured that the required information is always latest, organised, structured and available at the click of a button.
7. Reduced time for review/approval process
In a paper-based environment, everyone that has been involved knows just how much time is required for discussion, review and approval processes. If we zoomed into pre-execution activities, the review time could be shortened if the test scripts included in the document drafted were added from the library, where the test scripts are kept up to date by the SME. Similarly, in the post-execution review/approval process – with the right set-up, the reviewer/approver could be reviewing the section of the tests that has been completed while the rest of the document is still under execution, condition permitting. This wouldn’t be possible in a paper-based environment if the document were to be kept together at all times.
And there you have it – my top 7 reasons why pharmaceutical companies or any regulated companies for that matter, need a paperless validation solution.
At No deviation, we are partnered with Kneat Solutions, the leading validation software solution for the life sciences sector. The No deviation-Kneat Solutions partnership enables us to work strategically with organizations to comprehensively map, configure, optimise and digitise work processes to KneatGx™, a feature-rich paperless validation platform. It also helps us support deployment and provide ongoing support, whether it is a single process at one site, or involves large scale deployments covering multiple sites and numerous users.
Reach out to us for a full risk-based paperless validation with integrated commissioning and test plan or to bring efficiency to your existing paper-based IQ, OQ execution. You can also visit our website for more information on our services.
With 15 years of experience across the APAC region with a focus on Commissioning, Qualification & Validation in the pharmaceutical industry, Joon has gathered extensive hands-on as well as management experience. He also possesses in-depth knowledge in Regulation & Guidelines, Project Management, Change Control Process, and Lean Leadership.
