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Over the past decade, technological advancements have impacted nearly every industry in the world. The life sciences industry in particular has been revolutionized by such massive digital innovation. In a time when technological transformation is inevitable and patients can access product information in two clicks, what digital solutions in healthcare are companies turning to in order to keep up?
Long-standing regulatory affairs processes have recently been revamped in an effort to increase both transparency and efficiency. However, companies in the life sciences industry are still learning to overcome the issues that developing compliant products presents.
The push for digitalization has become evident during recent times, with the regulatory authorities advocating regulations like MDR. In this day and age, perhaps the first step for healthcare manufacturing companies is to embrace digitalization.
Luckily, Product Lifecycle Management (PLM) is the ticket into the digital world.
This article will shed light on the most exciting ways PLM and digital solutions in healthcare can help companies solve their most trying compliance challenges.
One of the biggest implications of modern technology in the life sciences industry is that the rules and regulations that govern it are in constant flux. Across the globe, the production processes of companies in the industry are being tested.
Far too many companies cannot keep tabs on the ever-changing landscape of requirements, which should be the cue to incorporate PLM-based strategies and digital solutions. Rather than pinpointed solutions that only solve one problem at a time and create organizational silos, PLM provides an interconnected platform of solutions that can solve many issues at once.
The key to regulatory compliance is the ability to efficiently trace product changes throughout the product lifecycle. If product data is stored across many different systems, though, that creates confusion across an organization, slows down the process, and leads to increased costs. Sound familiar?
Digital solutions in healthcare, like a PLM system, allow companies to generate a ‘single source of truth’ for product data and avoid the common pitfalls within the regulatory process.
When unexpected changes occur, the benefits of a ‘single source of truth’ become even more apparent. Transparent access to product information, coupled with processes that have been built into the PLM system, enables companies to make quick changes and work much more effectively on new products.
The demand to expand into global markets is higher than ever for companies in the life sciences industry. However, global expansion is much easier said than done. There are numerous barriers to entry, the primary one being the differing regulations and requirements in each country.
At the development level, these systems ensure that everyone involved in a project (e.g., be it a design or submission project), regardless of geographic location, knows what they should be doing and when. Approval workflows and digital signatures are managed more efficiently by being part of a PLM system. At the management level, these platforms provide tools that allow key performance indicators (KPIs) to be tracked and measured.
Yet another integration that aids companies expanding globally is the addition of simple automations to the product renewal process. An automated alert system to keep track of product registrations all over the world will ensure that not a single product renewal is forgotten or overlooked.
Simple automations can not only help companies from a time-management standpoint, but they can also prevent significant monetary losses. When implemented and used effectively, digital solutions in healthcare can turn regulatory compliance from a challenge into a competitive advantage.
When it comes to the regulatory requirements that healthcare organizations must follow to launch their products into the market, half the battle is deciphering which rules apply to each product. Fortunately, the process-based approach of PLM systems can assist companies here too.
Each regulatory authority has their own way of managing a product submission, meaning life sciences companies must alter one specific product submission various times so as to cater to the exact requirements. Multiply this tedious process by hundreds of thousands of products and it quickly gets out of hand.
Simply implementing a PLM system will not solve this regulatory dilemma but incorporating a process-based approach within the system will certainly help.
Mapping processes within a PLM system allows companies to take advantage of standardized and harmonized templates that capture how each regulatory authorities’ rules should be interpreted. Digital solutions in healthcare can lead to standardization of the most up-to-date rules for each regulatory authority.
By utilizing templates to cover what each specific authority requires, companies can begin to incorporate regulatory intelligence into their digital platforms. That way, when working with certain authorities down the line, companies can remain consistent and, therefore, compliant.
Just as there are two sides to every story, there are two sides to the products that are coming out of the life sciences industry. Of course, there is the manufacturing company, but there is also the product user or patient themselves. Amazingly enough, digital solutions in healthcare can benefit both parties.
Databases like GUDID in the United States and EUDAMED in Europe have brought essential product information to the general public. Nowadays, patients have quick access to any adverse events, misuse, or incidents associated with a certain product.
The new technology behind these public databases is best matched with digital solutions on the company side.
Specifically, the information management side of PLM systems utilizes tools that can map the production process along the entirety of the product’s lifecycle. Any and all product information and data can be linked via a digital thread to the product itself within these platforms, thereby also facilitating an efficient process when uploading data to different country’s UDI databases
Although companies can extract product information from a third party for these public databases, why not make things simpler? Product-centric platforms allow companies to avoid going through multiple channels for UDI data altogether, which means patients have access to the information much sooner.
A common misconception about audits is that the faster a life sciences company can get through them, the better off they are. However, the reality is that efficiency will always trump speed in an audit. The tools and solutions PLM offers directly affect how efficient a company facing an audit can truly be.
One of the main consequences of utilizing digital solutions in healthcare is that they transform the methodology behind the entire regulatory process. Rather than thinking about audits after the fact, a digital platform facilitates an audit-ready approach that can be seen from product onset to market authorization.
Audits are the moment when all the benefits of implementing a PLM solution come to a head. From easily outlining the ‘red thread’ of product changes to quickly locating a specific license, the methodical application of digital tools will be obvious.
In the life sciences industry, it’s not a matter of if an audit will happen, but when. Imagine having a system in place that prepares a company to be audit-ready.
There are four cornerstones that can lead to the successful adoption of a PLM solution in a company: data, people, tools, and processes. It’s no coincidence that control over these very principles can make or break market authorization in the life sciences world.
Implementing a PLM solution is no small feat for a company that is already scrambling to keep up with the modern regulatory landscape. Nevertheless, digital tools could mean the difference between companies that excel in the modern-day life sciences industry and those that miss the mark.