Sikich LLP is a 1000-member business advisory firm that offers ERP and CRM technology and accounting services to a broad array of companies, including life sciences, tailored to fit their specific needs. In April 2021, Sikich acquired Process Stream, a leader in digital transformation services for regulated industries, which includes life sciences. The acquisition expands Sikich’s offerings into quality management and IT compliance, enabling the firm to help companies as they journey from early stages through commercialization.
Big4Bio Editor Marie Daghlian recently spoke with Mike Kean, partner and head of Sikich’s ERP and CRM practices, and Bobby Roy, former CEO of Process Stream and Sikich partner in charge of regulatory quality and compliance, to discuss the additional services that the Process Stream team adds to Sikich’s offerings to help life sciences companies succeed.
Big4Bio: Process Stream has expanded on the services Sikich provides to the life sciences industry. Briefly, what does Process Stream bring to the table?
Bobby Roy: Process Stream, prior to the acquisition by Sikich, focused on quality and compliance consulting in the life sciences space. We are experts in business process and implementation consulting for quality management systems—those are all the critical quality processes such as complaints, deviations, investigations, CAPA (Corrective Action/Preventive Action), change control— all the pertinent workflows and processes that are important in creating a successful Quality System.
We also offer managed services in these areas. After we implement, there continues to be updates on guidance as well as changes to internal Quality SOP’s. So, there’s this ongoing updating of these systems and processes to make sure they stay consistent with the company’s Quality Vision and updated guidelines. Our goal is to partner with clients to ensure they are successfully maintaining their business systems.
B4B: What led to the decision to acquire Process Stream?
Mike Kean: Our clients have asked for these services in the past and we’ve often partnered with other organizations for these types of services. We have a depth of experience in life sciences and this expanded offering helps round out what we can offer to life sciences customers, which continues to be a strong client base for us. We now can offer more services at a higher level, so we’re very excited about Bob’s team. Process Stream has a great reputation in the market and jointly we can help each other service clients across the board.
B4B: Compliance is top of mind at FDA with product quality and comparability in drug development and manufacturing and compliance closely monitored by the agency. How does Process Stream’s specialization in IT compliance and quality management systems implementations streamline the process and assure compliance to cGMP?
Roy: We do that in several ways. Our Quality Management Practice works with companies to build out best of breed quality processes and implement those in their quality management system. In addition, our IT Quality & Compliance practice focuses on computer systems validation, where we validate a variety of different types of systems within the ecosystem. Early in our discussions with Sikich, we noticed that was an area where we could immediately add value. Mike’s team indicated that was not one of the functions they currently provided but is something that is often asked for when they do implementations for biotech companies. So, it immediately made sense to put these together as another value-added service that we could offer.
It’s an interesting space with the new CSA (computer software assurance) guidelines that will be coming down from the FDA. We have been closely monitoring those FDA CSA guidelines to streamline and automate software validation activities. For the past few years, we have been leveraging GAMP 5 Risk-Based Validation Approach to validate computerized systems implementations. The new FDA CSA guidelines align with our best practice validation methodology as well as the GAMP 5 Risk-Based Validation Approach.
Another important development is the use of cloud/SaaS applications and how we maintain a validated state. Many new computer systems are now going to the cloud, and the question becomes: How do you maintain validated state within a cloud application? Just like your iPhone, every couple of months you might have an update which potentially creates changes to items that were already validated. You want to maintain control of that system. To answer that question, we’ve been working to enhance our offerings with new services that allow companies to go to cloud/SaaS-based applications and maintain validated state. That’s been a very interesting and exciting area we are growing into, and something that we can offer within the Sikich ecosystem.
B4B: It sounds like an important offering. If you can’t assure that the system is validated, then you can’t assure the FDA that your quality processes and analyses will hold up.
Roy: When we put in a quality system, we go through a rigorous validation by completing risk documents, requirements documents, design documents and IQs, OQs & PQs to make sure that system is controlled. With a cloud-based system, you go through that process and three months later the vendor pushes an enhancement that might change some of that core functionality. It is not really validated anymore because functionality may have changed breaking test cases or altering requirements. Maintaining that validated state is a new paradigm so it means rethinking old processes.
B4B: Managing the terabytes of data produced by the lifecycle of drug development can become extremely burdensome and has led to the digital transformation of the industry. How does the acquisition of Process Stream advance the digitalization of companies and streamline the management of the reams of data constantly being produced?
Roy: It’s a great question.
It’s a theme that we started to see a few years back. Ten to 12 years ago, everybody started using enterprise systems, and a few years back we started to see that now you have years of data in that system and a number of different issues might start to plague the system.
The other theme that emerged was M&A and divestiture activity in life sciences. As part of these activities, companies need a solution for what to do with their Quality Data. A few years ago, we started to build out products that could solve these problems. Ours is specifically in the quality management area. We built a software product called migrationIQ that deals with the migration of data, which allows for M&A and divestiture carve outs. It allows you to move data in a validated way. Since these are all validated applications, it must be done in a controlled manner via a validated data migration application.
Our newest product, introduced to the market this year, is called archiveIQ. It allows you to take guidelines from regulatory bodies on data retention. Say you are required to have 7 years of a certain record type. archiveIQ allows collection of that data to be put on a schedule, so once it hits the threshold, it will archive out of the system. Therefore, the core systems don’t contain terabytes of data, only the data required by the guidelines. This allows the company to keep a separate archive system that it can access if it needs to, so the additional data is not lost.
B4B: Can you provide an example of how the acquisition has enhanced your offerings from feedback you have received from clients?
Kean: We no longer onboard other vendors to service our clients in the areas that are now covered by Process Stream’s expertise. We do a lot of accounting and financial services and to also offer validation services is a big plus for our clients. The biggest thing they are looking for is someone who knows their industry. We are now able to talk across the organization where a few years ago we were just talking to the finance team.
B4B: So now you can talk about all the necessary process steps a company has to go through to commercialization.
Kean: Not just that, now we can give them best of breed solutions across the board. As consultants, it’s kind of fun and it takes our services to another level. We’re not just a vendor, we become a partner to these clients. A lot of these organizations don’t want to hire a bunch of employees and would rather outsource services and spend their money advancing their drug candidates.
Roy: One of the things that I love, and Mike and I talked about this early on when we first joined, is that we can follow the customer’s growth journey. With Mike’s team, many of the customers are early-stage biotech companies that are just getting started and trying to figure out commercialization. We are now able to follow that journey as that client continues to grow and expand, and we have a multitude of solutions that support them the whole way.
Kean: Quite honestly, the other side is our employee satisfaction, because they know what is going on, they enjoy it. These are consultants. They enjoy helping clients and adding value. It’s a win-win across the board. And it’s about the clients, giving them more options.
B4B: It sounds like the merger is a positive all around.
Kean: It’s about culture, doing it right.
Roy: Sikich has done a tremendous job bringing us in gradually so as not to disrupt our current framework. But they’ve also helped lay groundwork for the future. It’s been a fantastic transition. I am excited about how we will continue to evolve and bring best-of-breed solutions to the life sciences and biotech industries.
B4B: Thank you both.