The first Best Practices on Quality Management in Pharmaceutical Organizations date back almost 100 years. The book "The Principles of Scientific Management" by engineer Frederick Winslow Taylor, which provided the first approach to quality in industrial organizations, including the use of clearly defined inspections and tasks performed under standardized conditions, was written in 1911.
One could say: "but we adopt the most recent Best Practices ". And how do you know what they are? There is no regulatory body that periodically publishes updates on Best Practices. Nowadays, even the best practices of a year ago may turn out to be obsolete.
In a world where the only stable thing is change, how do you reconcile the news with the best practices? We all talk about " disruptive " technologies, we say that Industry 4.0 is a true industrial revolution, but few wonder how the concept of "revolution", which indicates a sudden change, can be reconciled with that of "Best Practices" which presupposes stability and safety.
WHAT ARE THE BEST PRACTICES?
Wanting to use simple language, the best practices say "do as others have done, if it worked for them it will work for you too". Shame that the others did it a while ago, at best they just finished the project. 10-15 years ago this approach could have been fine, while today it could be a risk. Indeed, it is completely normal that companies that have just implemented the eQMS are already thinking about how to change it, improve it. Let's see why.
First of all, are we sure that the Quality processes are the same in all companies? We believe that following best practices is beneficial if:
The company already adopts the same processes as those of the so-called Best Practices. In other words, its standardization process is almost over.
The company wants to adopt the processes defined by the best practices, even if its current processes are far from standard. This is the case where management sees no use in adopting customized processes, or worse, sees it as costly and wasteful, and therefore consciously chooses this extreme standardization path supported by a "Best Practices" system. But, above all, the management is aware of the organizational transformation that the company will have to carry out in a very short time and of all the ensuing consequences. Let us remember that in a pharmaceutical company the quality system is closely integrated with all the critical GMP departments, so the eQMS will impact the whole company!
For other cases, for example, when customized processes are not perceived as a problem but rather are seen as a jealously guarded competitive advantage, the slogan "best practices" is better not to be used by the seller to convince the customer to buy.
Of course these two realities, totally standard processes and totally customized processes are the two opposite and rather rare extremes. The truth is, as always, in the middle.
We don't want to say that Best Practices by themselves are bad. What doesn't fill right is the word "best". For whom are these practices best? Of course, the more companies have successfully adopted them, the more they have the right to be called "good", "quite good", "very good". But "best" is an absolute judgment ... something that is good for 100% of companies.
Our philosophy is to adopt the most suitable approach for each individual customer. For most companies, in fact, the situation is not homogeneous: some processes are already standard, others, due to a delay in evolution, for historical reasons or for the express will of the company, are highly customized.
How is it done in these cases?
Even the very concept of Best Practices is often interpreted in different ways. And this interpretation changes over time in accordance to the context itself. Let's see some examples of these interpretations:
Best Practices that define standard processes and features
BPs describing better selection or design approaches
BP for Data Integrity, Data Governance and Cyber Security
Terminology BP (adoption of a common language)
BPs that list the areas of quality system (document management, Quality Events, non-conformities, Change Control, etc)
...
But if we think about it, most SW suppliers on the pharmaceutical market adopt these general Best Practices (there are no detailed best practices) by definition. Therefore, BPs can be used as an exclusion criterion. In other words, for a pharmaceutical SW, these BPs are a necessary but not sufficient requirement to be included in a shortlist of candidates.
In the broadest sense, we can see Best Practices as an exchange of views between different companies that have common problems. And, of course, it is always useful to confront other realities, learning useful lessons from their experiences. But just as no two people are alike, no two companies are the same, so even if a company decides to adopt some best practices, its path will still be unique and unrepeatable.
Returning to the common problems of various Life Sciences companies, we can define another type of Best Practices: a list of similar URSs that partially or totally overlap. But this does not mean that even the final solution, which covers the same URS, must necessarily be the same!
HOW RISKY IS IT TO ADOPT OUTDATED BEST PRACTICES?
Any quality system, paper-based or digital, aims to manage changes in a controlled and risk-based way, in all critical GMP areas, including that of quality processes. But if the eQMS itself can't change quickly to accommodate ever-changing needs, it's like the shoemaker in broken shoes.
Adopting Best Practices essentially means forcing the company to adapt to more or less recent rules, defined by someone else. We emphasize again that we do not mean that this is always a bad thing, on the contrary. Actually, to be able to follow recent and efficient procedures is a great advantage.
But if you make a mistake in choosing the best practices, through the selection of a supplier and a SW not suitable for the company, the risk is to block the technological growth of the company or, in the worst cases, to regress rather than evolve.
Is there, therefore, a way to innovate by adopting best practices?
what DOES FDA THINK about?
Companies in regulated industries can "get excited" when it comes to adopting new technologies. Since human lives are at stake this is more than understandable. But getting excited doesn't mean giving up. The fact is that regulators are pushing companies to adopt new technologies in areas that increase the stability, security and Data Integrity.
Instead, pharmaceutical companies are also looking forward to adopting technologies that allow them to extract value from their data, such as Artificial Intelligence. While regulators have a more cautious approach to these technologies, as they seem to run counter to their goals cited above.
In any case, given this unstoppable wave, the FDA itself has decided to launch a plan that aims to develop new regulations precisely to facilitate the adoption of technologies based on the use of data (AI, ML) even in Life Science companies. The plan in question, Data Modernization Action Plan (DMAP), is just a plan for now, and the regulations are still "Work in progress". We hope to see the first results soon and to learn about the new Good Machine Learning Practices (GMLPs).
And since objective data are the main "cause" of the decisions that lead to process changes, these new regulations will necessarily also deal with the topic of Change Management.
For example, exploiting data to continuously improve (i.e. change) processes means potential impact on their validation. And SW vendors, who saw this trend long before the FDA, have long been competing for who will first create highly configurable software that has low validation impacts.
So now we can see the existence of two schools of thought:
Best Practices (promoted by established companies that guarantee them)
Start-ups that are creating "super-configurable" SW which, while guaranteeing best practices, want to offer customers great flexibility with low impact on validation.
Always change a winning team!
We all know the saying "Never change a winning team!" and, probably, many understand its danger. There is no need to change your winning team only if the opposing team does not change as well. But the world, with its opponents, the pitch, and the rules, is constantly changing. So our credo is "Always change a winning team!"
In the IT world, there is a similar expression: "The software that works is obsolete." We only know the software and products that have been successful, but we will never know the projects and ideas that have failed to establish themselves on the market. The reasons may be different but one of these is hard to doubt: if a product was successful it means that there was a strong component of innovation at the base. This condition, that is, continuous innovation, it is necessary not only to create good software but also to maintain the market share gained. Even the reputation of the IT giants will quickly fade if they stop constantly investing in the innovation of their products. For this reason, when a new version of a good SW comes out, the development teams have been working on the next version for some time.
Unfortunately, in the pharmaceutical industry, there is the "plague" that prevents innovating too often, the name of which is Computer System Validation. And this is why the Pharma sector is among the last in the journey of digitization. But there is little to do, innovation is mandatory and is synonymous with continuous change.
So we could say that the real Best Practices for a pharmaceutical SW is its ability to quickly adapt to new needs without impacting too much on validation!
This is even more true for eQMS software because, in addition to doing their job, that of managing changes in other departments, they must in turn change easily, coming to have complete mastery of the change.
Obviously, to be the master of change you have to know how to see it arriving, and changes can come from any direction: from the outside (customers, competition, new regulations, new technologies ...) but also from the inside (data, connectivity, ciclo di Deming...)
Predictive analytics based on machine learning (ML), natural language processing (NLP), and other forms of artificial intelligence (AI) can provide even more insight into how to proactively drive business success. In this way we go from being the chaser of change to being the leader of change. The technologies of the fourth industrial revolution certainly have a huge impact on the company, but this impact can only start with small changes, which goes against the concept of revolution.
But how is it possible to achieve all this without causing huge impacts on validation?
GOODBYE VALIDATION ...?
We certainly don't want to reveal any news or secrets. The GAMP (Good Automated Manufacturing Practice) have existed for 30 years and have now reached version 5 and describe the 5 categories of software and the related validation approach.
Of these we are most interested in the last 2 categories.
Category 5:
Let's start from this because, in chronological terms, they are "classic" software and easier to understand. These are applications (or parts of them) developed specifically to meet specific customer requests. Being totally new and customized, this software must undergo a convalida completa (FAT, SAT, IQ, OQ, etc.). The depth and detail of this validation will be determined by the GMP impact that the software in question entails.
Category 4:
Configurable software: The system comes with a set of ready-to-use modules, features, and processes (the famous Best Practices), which means tested, documented, and pre-validated. Added to these are configured features that cover customer specific processes that were not covered by the default template.
For GAMP Category 4 software, the approach at the validation can be to use vendor's documentation and testing to demonstrate the suitability of standard modules, and limit additional verifications to critical functions and regulatory compliance functions only (security, electronic signatures, audit trails, etc.).
A nice plus!
What's the news, then? The more advanced the software, the more configurable it is, and therefore the less effort you have to put into validation. And the novelty lies in the fact that thanks to new technologies, eQMS software is born that allows covering increasingly customized customer processes più personalizzati just by the configurations.
In other words, you can get the same benefits offered by the adoption of Best Practices without stiffening the company and without "copying" what others have done.
CONCLUSIONS
To obtain a new generation of eQMS software starting from one created 15-20 years ago it is necessary to rewrite it from scratch, which is not always possible. Both new advanced digital skills and esperienza decennale nei processi qualità combined with in-depth knowledge of their software. But it may happen that the original team is no longer in the company while the new skills have not yet been found. So it often happens that established software vendors directly move their creatures to the cloud. This makes them neither more configurable nor more technologically advanced. But the good reputation, in which these suppliers have invested for decades, does its job and the customers, who have not yet acquired the new skills necessary to evaluate the characteristics now mandatory today, continue to trust the brand risking falling into a trap.
The main message we want to give is not to throw yourself into a solution / supplier just because it promises to implement Best Practices. First of all, it is necessary to evaluate how far your company is from the so-called standard.
The GMPs (Good Manufacturing Practice) themselves, published and updated by regulatory bodies, are not prescriptive standards on how to manufacture medicines. These are requirements that must be met during production. But there are so many ways these requirements can be covered. It is therefore the responsibility of each company to find and implement the best and most efficient way to comply with regulatory regulations.
With Best Practices, the discussion is even broader. There is no official body or document that establishes what Best Practices are.
The Best Practices are nothing more than a summary of the procedures, actions, and experiences of companies (and their suppliers) that have already traveled a path reaching satisfactory results. From this point of view, they are obviously a precious source of information from which to draw food for thought.
Whether or not to adopt the Best Practices must be a conscious choice, based on an in-depth analysis of one's own reality and on the comparison of this with the experience of other companies. The " if it worked for others it will work for us " approach hoping to save valuable resources during selection may not be a winner. The savings in time and money obtained thanks to the selection based exclusively on Best Practices, could be lost already in the first months of using the eQMS if the choice turns out to be wrong.
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The guide to the digitization of the Pharmaceutical Quality System
Le "Best Practices" sono ancora il miglior criterio di selezione ed implementazione di un eQMS?