Growing product complexity and evolving market demands are driving regulations to become more stringent than ever before. In response, many companies are digitizing their compliance efforts to streamline the way they collect, share, and manage compliance-related data. Forward-looking companies are looking to transition from document-based compliance to integrated, holistic solutions that enable them to ensure compliance, keep their edge in the market, and not miss out on opportunities for innovation. Read on to learn more about three key industries where digitization is revolutionizing regulatory compliance, and what the implications for product development are as a whole!
Traditional document-based compliance has certainly stuck around for a long time. But due to digitization, many companies are transitioning to cloud-based collaborative platforms and holistic management solutions to manage regulatory compliance. Nowadays, regulatory premarket submissions can be done electronically with reports pulled from integrated lifecycle management platforms, compliance-related data capture can be automated, and audits can be a smoother and much less stressful experience overall. And who doesn’t want that?
Let’s take a look at three key safety-critical industries to see how digitization is affecting their compliance processes: automotive, medical device development, and pharma.
Industry #1: Automotive
Technologies like autonomous driving, connectivity, electrification, and shared mobility are radically transforming the automotive product development landscape, providing endless opportunities for innovation in the industry. In parallel, these key trends also lead to increasing vehicle complexity because of the vast amount of embedded software and sophisticated electronics they require to work.
Picture this: while a Boeing 787 Dreamliner requires 14 million lines of code, a modern car now runs on a whopping 100 million. So it doesn’t come as a surprise that as vehicles become more complex, so does compliance with functional safety guidelines and regulatory requirements. As a result, amidst mounting complexity, traditional document-based verification is no longer cutting it.
Until now, verification documents were shared via never-ending email chains and stored on hard drives, network-attached storage (NAS) devices & shared folders, and in some cases, still on paper in filing cabinets. Unfortunately, this manual approach simply does not allow for the level of organization, traceability, and transparency that modern vehicle development and evolving regulations require.
Imagine that after receiving a verification request, an engineer still needs to manually track down necessary information (sometimes through phone calls, from other offices, and literally digging through file cabinets). Then they need to double and triple-check that it’s up-to-date, and despite all of their efforts, they can’t access a birds-eye view of all the testing to make sure all the necessary bases have been covered. In some cases, this can lead to noncompliance fines and even criminal prosecutions.
Benefits of digitization for automotive compliance
Digital tools like cloud-based Application Lifecycle Management and collaboration platforms provide a single source of truth for the whole supply chain and product lifecycle for stakeholders. They can help by:
- Automating the management of artifacts and processes all the way from specifications and documentation to test results so that everyone can follow the process and status of tasks
- Documenting changing requirements and how changes affect design and development
- Using real-time data dashboards to keep up with processes and for the continuous improvement of processes
In short, instead of using time-consuming and cumbersome manual processes, digital solutions can collect, coordinate, analyze, and report on all the lifecycle data involved in the development of digital mobility products. Having all this data in the same place allows different stakeholders (think development, engineering, marketing, finance, legal, compliance, and more) to stay on the same page using up-to-date data in the product development ecosystem. It also helps make sure that established processes are not deviated from, and simplifies process documentation, thus accelerating regulatory compliance.
Industry #2: Medical device development
Medical device technology is at a pivotal moment in history. The intersection between medicine and technological innovation has the potential to truly transform peoples’ lives.
Digitization is helping healthcare providers carry out extremely complex procedures, make fewer errors in diagnosis and treatment, and improve supply-chain management as well as drug development. Wearable devices like fitness trackers and smart jewelry also generate a colossal amount of health-related data that could potentially be used to inform medical device regulatory deliberations.
However, as with all safety-critical industries, there is also the possibility for things to go very wrong, as the FDA’s 2021 extensive list of medical device recalls can attest to. Medical device developers may be jumping at the gun to take advantage of technological innovations, but in order to do so, they need to digitize their own conventional approach to compliance as well.
Traditionally, regulation in medical device development depends on devices meeting certain regulatory standards and on manufacturers supplying a huge amount of safety and testing data (usually derived from clinical trials) to regulators in order to demonstrate compliance. However, traditional document-based compliance simply cannot keep up with what it takes to comply with evolving regulations.
How digitization helps compliance in medical device development
As the amount and complexity of software embedded into medical devices increases, MedTech developers are also leveraging modern software solutions to simplify their compliance-related activities. Tools such as digital Quality Management System platforms or integrated ALM tools help medical device developers in the following areas:
Ineffective document management is one of the most frequent causes of warning letters from regulatory agencies like the FDA for example. Using a digital solution, it is much more straightforward to collect, revise, store, and publish the huge amount of documentation required for compliance. Modern software tools also allow teams to establish links between related artifacts, ensuring the traceability that is a key requirement of most regulations. Through smart data export and reporting options, having a central repository of information also decreases the time it takes to register or submit devices to new markets.
Identifying issues early on in the product life cycle is crucial for corrective action. These need to be recorded exhaustively for compliance purposes, with relevant links to all the connected materials, which could be customer complaints, faulty materials, or audit results for example. Once you have identified the issue, a corrective action plan needs to be devised, documented, and executed.
Tracking evolving regulations
Regulations pertaining to medical devices are constantly growing and evolving over time. Some examples of recently updated medtech regulations are the European Union’s Medical Device Regulation as well as updates made to the ISO 13485. Medical device developers are expected by regulatory bodies to stay on top of them and have the documentation to prove it. Having a holistic management system that keeps track of all the requirements and changes also allows medical device manufacturers to automate much of device registration and submissions management, so that they can easily stay on top of regulatory changes.
Improving internal and external collaboration
Breaking down silos and making sure everyone has access to the right information is important for following changes along the product lifecycle and for working with third party suppliers like vendors who provide raw materials or components to the product development organization. With a higher level of transparency, communication, and traceability, noncompliance issues are spotted much quicker. It also helps to collect data from the shop floor that helps improve decision-making and strategic choices.
Industry #3: Pharmaceuticals
Traditionally, compliance with GAMP requirements in pharma systems validation has relied on individual expertise and manual processes. In other words, a large amount of documents in boxes which may or may not be transferred to PDFs eventually. However, without modernizing these operations, it will become impossible to keep up with the pace of innovation.
This is because regulatory requirements in pharma, similarly to the automotive and medical device industries, are becoming increasingly demanding, while the costs of paper-based documentation are rising.
Compliance in pharma requires a huge amount of resources to identify issues, train staff, generate reports, and create and manage policies. All of this is made more difficult by manual processes and document management, leading to longer searches for information, more meetings, and answering endless queries from colleagues at work. It is hard to retrieve this data during audits and inspections (if it can be found at all) which increases the possibility of errors and miscommunication, and by extension, noncompliance.
Advantages of digitizing pharmaceutical systems validation processes
Digital technologies have the potential to bring compliance to the forefront as a value-creating part of a pharmaceutical company. They contextualize data and provide insights that can be used to make strategic business decisions. They can also help to automate workflows and streamline operations, reduce manual work, as well as facilitate the management of policies, contracts, and training – besides simplifying the work of systems validation in general.
Some other benefits digitization brings to compliance in pharmaceutical companies are:
- Improved documentation: A digital quality management system (QMS) can keep records and information up-to-date so that pharma companies can maintain an audit-ready production system at all times.
- Automated risk assessment: A cloud-based collaboration platform can automate this process using surveys and notifications to maximize the amount of data collected. Then this data can be analyzed using risk weighting and scoring algorithms, to prioritize risks accordingly during planning sessions.
- Training sessions: Automation and tracking can help to make sure that training takes place, was completed, and is recorded as complete in the system.
- Better audits: With all documents and records in the same place, audits can go much more smoothly by giving inspectors quick and transparent access to up-to-date information.
For more information on how cloud-based collaborative platforms can help your compliance efforts, check out our related article here: