This is a blog post by Intland’s Technical Consultant Anita Nemes-Solymosi.
Digitalization in the pharma industry is a hot topic. Over the past couple of years, there have been hundreds of blog posts, comments, and articles written about how digital transformation affects the pharma sector, and how pharmaceutical validation and project management especially could benefit from going digital. So why is paper-based document management still considered the standard and accepted way of managing validation in the pharma sector, while the industry itself has undergone tremendous changes and development in terms of technology?
About the author
Anita Nemes-Solymosi is a technical consultant specializing in the pharmaceutical industry. Before joining Intland Software a year ago as a Technical Consultant, Anita had worked in several huge pharma projects as a validation expert. It was on these projects that she first implemented Intland's products and experienced first-hand the benefits that come with the digitalization of validation processes. Nowadays, for customers like Inivata, Cooptech, and CSL Behring, she offers efficient solutions supported by personalized configuration to suit the validation needs of organizations of all sizes.
Inertia in pharmaceutical development
Experience shows that the pharmaceutical industry is a very conservative industry that’s based on traditional principles and that is not easily digitalized. That said, it’s important to mention that with the advent of Pharma IoT, more and more companies are offering technology-based solutions. This has created some consumer demand that drives pharma companies towards forgetting paper-based, old school solutions.
You may wonder: with all that enormous technological development the industry, how have internal processes changed? The fundamental concept behind Pharma IoT is to provide IT products and services that support medical products and related care processes to an open-minded target audience. Think mobile devices, applications, cloud solutions, etc. So if the industry itself sells such modern tools and wants to get its customers into modern “disease management”, why is it still stuck using paper trails and e-mails when implementing a new system or production plant?
What’s holding back digitalization?
I have had the good fortune to follow several large-scale projects, such as the entire process of capacity extension for a particular pharmaceutical factory. When a company starts to introduce electronic data management practices and looks for guidance in regulations and standards, GMP (or the Good Manufacturing Practice) is the first one that comes to mind. GMP aims to ensure that the QA (Quality Assurance) system operated by the drug company actually guarantees that products of the same quality as the pedigree are placed on the market. The next step is GAMP (the Good Automated Manufacturing Practice) which guidance aims to ensure that computerized systems are fit for their intended use and meet current regulatory requirements by building upon existing industry good practice in an efficient and effective manner. GAMP 5, the latest revision of GAMP, is the extended guideline for the pharmaceutical industry which has been significantly updated in recent years to align with modern regulatory and industry concepts and terminology.
Taking our concept of digitalization a step further with another set of guidelines: the U.S. Food and Drug Administration (FDA) issued its Title 21 CFR Part 11 regulation which describes how electronic data should be handled. This document also covers the use of electronic signatures.
GMP allows data to be recorded by an electronic data processing system, but a detailed description of this method must be provided, and the accuracy of the data must be verified. Besides, there is a requirement that the data recorded by the electronic data processing system can only be modified or overwritten by authorized persons. Furthermore, there are plenty of detailed and relevant rules for what criteria must be met if a pharmaceutical company declares that it generates and manages its primary data on a computer, and 21 CFR 11 also sets strict requirements for the maintenance and handling of electronic data.
Drawbacks of paper-based processes
So, in answer to my own question posed earlier: in the multitude of rules, it is no wonder that pharmaceutical companies tend to opt for tried and tested paper- and Excel-based validation and verification processes combined with manual signatures. That approach is bound to reach its limits.
When a pharmaceutical company enters into more complex, multi-participant projects where high quality is a fundamental requirement, these old, proven processes just won’t cut it. From the perspective of the project initiator, but just as much from the perspectives of the main contractor as well as subcontractors, there needs to be effective collaboration in order for implementation to be successful.
Pharmaceutical project management and validation are complicated processes that are easily drowned in emails. Several times over the course of my career I have been involved in projects where expensive engineering hours were paid for by a pharmaceutical company due to lengthy validation processes that could have been easily avoided if those processes had not been done on paper but in an easy-to-use, shared software platform.
Paper-based validation: a dead-end street
In contrast to negative experiences, fortunately, there are a number of positive examples to show that pharmaceutical companies that aim to increase efficiency are willing to embark on a path of change.
I have personally accompanied such a transition process just before joining Intland Software’s team. The established process there actually consisted of so many tools that it would be difficult to take an inventory of all of them. We needed 2-3 printers, at least 50 pens of the same colour for project participants (had we used different coloured pens, the auditor could have assumed that specifications or evidence had been signed at different times).
I needed thousands of pieces of printing paper and plenty of tireless engineers, quality assurance experts, and subcontractors – all of whom, to the best of their knowledge, commented and reviewed on the freshly printed specifications on paper, and in untraceable emails if any item still needed modifications. Subsequently, the persons assigned reprinted and re-commented documents, approved them with a carefully chosen pen, while strictly adhering to regulations. Only after all this could we transition to the work processes defined in the V-model’s next phase.
In fact, if you think about it, we haven’t even started the testing procedure at this stage. That’s where there can be lots of deviation, change requests and evidence issues, and a number of project participants such as subcontractors can get involved. We’re far from being done.
Going digital with pharma V&V
How can this be radically changed with a single piece of software? To this, your answer may be that there’s actually no way this can be done without disrupting the deeply ingrained operation – an undertaking akin to reaching into a wasps’ nest without protective equipment. On the other hand, in my own experience, with the right knowledge, and with the collaboration and support of all involved teams, a single piece of software can indeed initiate a change that can then save an unimaginable amount of time, energy, and cost.
The recipe is as follows:
- Implement a validated software for your site with the help of Quality Assurance and other relevant teams you want to involve. I suggest using codebeamer X for which Intland Software has created a Validation Kit to facilitate and speed up the tool qualification
- Support users in getting up to speed with using the new system. Help them implement processes during training to make sure they fully understand how the tool works. Again, codebeamer X's clear user interface, various training videos, and the active support of Intland’s team helps make this process short and painless.
- Rely on preconfigured templates wherever possible to save configuration time. Intland’s pharmaceutical template is easy to customize so you don't have to spend months implementing your own processes in a brand new system.
- Start using the software live on a newly started project, where you can experience the features and expand any items that may be missing.
In exchange for an initial setup and configuration period (that is made less effort-intensive through the use of templates), you’ll be:
- Providing all project participants with a personalized, user-friendly interface for a shared central platform
- Ensuring data consistency in always up-to-date, collaboratively edited documents
- Taking advantage of the easy integration of review and approval processes that meet industry standards.
Furthermore, in addition to handling your different requirements and documentation, the system also facilitates the test execution. Say goodbye to spending hours searching for screenshots of the relevant test and with it, the attached evidence. All this data is versioned and any and all changes are logged in codebeamer X, so when an audit occurs, it is easy to present both up-to-date documents with electronic signatures, and the associated references.
Granted, this recipe will require more of an upfront investment than buying a printer with loads of paper and a few pens of the same kind. But the man-hours saved after process stabilization is measurable, and that coupled with the enhanced project lifecycle visibility that digital systems provide makes it worthwhile for pharma companies to consider using such platforms.
In my opinion, the question here is not how much effort and time such a transition will take. The main question is when market pressure will make this transition inevitable. Early adopters are already rationalizing and simplifying the biggest pain point of their projects: verification and validation.