There’s never been a more exciting time for medical innovation. Since 2015, the industry has exploded, seeing an average of 150 new biotech startups launch each year. This growth is encouraging and promises a bright future –– especially for patients. But it also presents challenges. One of the greatest? Building quality assurance (QA) infrastructure.
“When biotech companies are formed, there is often no real urgency in establishing QA departments and setting up a QMS system,” says Ajay Sadhwani, Founder and Vice President of Operations at Harbor Clinical. “[Founders] know it’s needed and they value the importance, but from what I’ve seen, it’s not always a top priority early on.”
While the lack of urgency is understandable- startups need to move quickly and focus on things like funding and talent acquisition to get off the ground – a lack of QA focus presents significant risks. Considering the QA department is responsible for vetting product safety and keeping essential records, not having one can result in major headaches later on.
In this white paper, we take a closer look at why QA infrastructure matters. Specifically, we explain when it should be a priority and make recommendations for delegating this vital responsibility to an organization you trust.
Why is Quality Assurance infrastructure so important for biotechs?
Quality Assurance (QA) infrastructure is important for biotechs because it provides guidelines for product and patient safety. Additionally, it establishes a foundation for essential functions, such as employee training, documentation, and supply chain management. Beyond that, QA infrastructure ensures you’re prepared in the event of an audit or inspection.
There’s a popular saying in regulatory affairs circles: “If it’s not documented, it didn’t happen.” Without a QA infrastructure in place, you risk losing data and valuable time – weeks or even months of work could be invalidated by regulatory authorities like the FDA if it is not documented properly.
Thankfully, with the right partner, building QA infrastructure from the ground up doesn’t have to be a painstaking experience, and can provide an effective way to protect your organization, products, and employees.
When should Quality Assurance become a priority for emerging biotechs?
It’s best to lay a foundation for Quality Assurance early on. By outlining protocols for documentation, training, supply chain management and more, you can keep everyone on the same page and avoid common pitfalls.
This can be difficult for some emerging biotech companies, as funding is often tight, and you may not have the resources to bring on full-time employees at first. Rather than pushing QA to the back burner, consider partnering with a functional service provider (FSP) like Harbor Clinical. We have a stable of qualified fractional professionals who can scale as you grow. This approach isn’t as resource-intensive as creating your own QA department but it provides equally beneficial results.
How Harbor Clinical Can Help with Quality Assurance:
Now that you know outsourcing QA is an option, you’re probably wondering how it works. Here’s a breakdown:
Finding and Hiring a Head of Quality Assurance
A QA program is only as strong as its leadership team. Without someone to oversee your biotech’s operations, crucial findings and documentation might fall through the cracks. That’s why we work to find a director first. We’re connected with QA professionals all over the world and can easily find a qualified leader who aligns with your company culture and goals.
Connecting You With Professional QA Consultants and Subject Matter Experts
We know that startups may be operating on a limited budget, especially in the early stages. Cash flow shortages, tax obligations, and lack of capital can slow down your progress and present major obstacles.
Our fractional approach lets you pick and choose quality assurance professionals a la carte. We adhere to your budget, consulting with you at every step of the hiring process. As your company grows, we can scale up or down as necessary. This unique approach often reduces the need for full-time employees, providing more financial flexibility.
Ensuring Your QA Program Complies with FDA Requirements
The FDA has strict documentation requirements that need to be followed at every step of the production process. Our subject matter experts are well-versed in all of these protocols and work hand-in-hand with you to maintain compliance. This knowledge and expertise provide peace of mind while significantly reducing the risk of audits and investigations.
Helping You Choose the Best eQMS System For Your Needs
An electronic Quality Management System (eQMS) can be a significant expense, but it’s a key element to success and the cost is minimal compared to the financial risks that having a QMS in place mitigates. Consider that poor documentation might require you to repeat experiments all over again. Likewise, it can hamper your relationship with investors concerned about your approach to quality control.
Not all eQMS systems are created equal. Some lend themselves to larger, enterprise-level corporations, while others are designed to help smaller startups. At Harbor Clinical, we’re familiar with the various eQMS systems available. (Click through to read our white paper on Which eQMS is Best?) Our team works with you to determine the right system for your needs and budget. What’s more, we can help you choose the right point to implement it and scale up over time.
Quality Assurance Infrastructure – The Bottom Line
When your biotech is in its early stages, it can be tempting to push quality assurance (QA) infrastructure aside but sooner is almost always better when it comes to QA. Implementing a QA system right off the bat is crucial for many future functions, so why wait?
We understand that the process is daunting, but we’re here to help. We’ve guided countless emerging biotechs through the QA process. From hiring QA leadership and connecting companies with QA consultants to monitoring FDA compliance and making eQMS recommendations, we know what it takes to build a robust infrastructure where all systems are ready to go.
Interested in getting started? Contact us today! Call (781) 775-0342 or send an email to [email protected].