Which standards are relevant? Cutting down on research time with Compliance Navigator
Compliance Navigator has a very productive working relationship with Enable Injections, who’ve helped us to map out the future of the tool. We spoke to Dominick Villani to find out more about why they came to us in the first place.
"It's improved our system from all of those perspectives - cost, efficiency, quality, compliance."
Background
Enable Injections is a start-up. It develops and manufactures wearable devices that allow patients to administer drugs themselves in their own home. This has traditionally been difficult with high volume or high viscosity drugs. The discreet devices are worn on the body. They allow the patients to carry on with their daily life while the drugs are comfortably infused.
Currently, the technology is at the investigational stage and awaiting approval. Enable Injections is working with pharmaceutical companies to develop specific devices for specific drugs.
Like all start-ups, Enable Injections has had to manage both time and cost. Compliance is therefore a critical challenge; it can be slow and expensive. Dominick Villani is the company’s VP of Quality and Regulatory Affairs. It’s his role to ensure quality control, compliance and risk management. He looks after quality for the whole pipeline, including the Quality Engineering team – and he’s responsible for all technical files and submissions to authorities in the US, EU, and other global markets.
The customer need
Dominick’s role involves having to identify all the key standards and regulations – both domestic and international – that apply to the company’s devices. Before buying Compliance Navigator, he had to do this manually, a task that he describes as very challenging. “I would have to search using Google and read the various regulatory sites, to try and find what was applicable to our device. It took a lot of time for me and members of my team to sift through standards to find which were applicable and which were not. In most cases it turned out that only a small percentage were applicable.” In some cases, it was impossible to tell whether a standard applied without buying it first. “Sometimes I had to go out and buy a standard which we thought was applicable, only to find out it was not. We wasted time and money on that. I have a very limited budget for standards, so every penny matters."
Dominick was looking for a tool that would help him identify the applicable standards and regulations. He also needed to manage any revisions, because they affect the Declaration of Conformity statements that he needs to make. The website he’d been using would inform him about updates – but this would normally be months later. “This was frustrating. In addition, I had to spend the time to go through the standards, to fully understand what the changes were and do the impact assessment.” So when he learned about Compliance Navigator, and discovered that BSI provided experts who commentated on the impacts of changing standards, Dominick became very interested.
"Sometimes I had to go out and buy a standard that we thought was applicable, only to find out it was not. We wasted time and money on that."
The solution
Dominick describes the implementation of Compliance Navigator as “very quick and easy. It was speedy. I put in my purchase order in early January and within a week we were set up. One thing I really liked about it was the training - what was really impressive to me was the resources that were committed by BSI to ensure that we fully understand how the tool can be used and leveraged to meet our compliance requirements”. From the procedural perspective, Dominick obviously had to reflect the way people within the business should use the tool. But it needed very little effort to set it up. He particularly liked the hosted option. “Being Web-based means that I and my team can access it online from almost anywhere.”
Despite being a very new user, Dominick has already started using the Expert Commentary to understand areas that may not have been clear before. He also looks forward to the commentary when new regulations come in. “I’m also keen to look at ways we can use the system to manage the product lifecycle”, he adds. “But the main thing is that Compliance Navigator is going to help me maintain our compliance.”
"What was really impressive to me was the resources committed by BSI to ensure that we fully understand how the tool can be used and leveraged to meet our compliance requirements."
Customer benefits
Dominick says that he has saved a “huge” amount of time by not having to maintain a library of standards. Before, his engineers would ask him to buy a standard every time they felt they needed one. Now they have unlimited access to Compliance Navigator. So instead of coming to Dominick with a purchase request, they can just access the standards themselves.
“The cost of subscribing to Compliance Navigator is no higher than what I was paying before – buying standards online, some of which were applicable and some of which weren’t, keeping track of updates, buying replacement or updated standards, obsoleting the old ones, keeping a paper trail.”
Dominick and his team are setting up Product Profiles. Each Product Profile lists all the applicable standards and regulations that affect that device. That feeds into their design requirements. “That has helped out tremendously,” says Dominick. The system also tells him where a regulation change might impact the Product Profiles. It has also helped from a quality perspective. It has improved compliance, traceability and tracking updates. The net effect is that it has given Dominick a systematised basis for drafting the Declaration of Conformity for a product. It’s a huge advantage over the old paper-based system. Dominick sums it all up: “It’s improved our system from all of those perspectives – cost, efficiency, quality, compliance, all those different angles”.
