Solutions2Projects, LLC: IT Strategy, IT Compliance, and IT Systems Consulting

I’ve seen a lot change in biotech, medical device, diagnostic, and digital health companies over the last 20+ years especially over the last 15 years as a consultant.

With COVID, we are seeing these life sciences companies embrace technology to optimize business performance and get to market faster. This is a good thing. I am hoping that even once we are out of this craziness, that we will see greater technology adoption in the industry.

As a businessperson who understands technology in a regulated industry, I have an unusual perspective given the distributed focus of services I provide.

To that end, I was asked how I work with these kinds of companies and offer up the following.

Swiss Army Knife of Consultants

I’ve been described as the Swiss army knife of consultants. I provide biotech, medical device, diagnostic, and digital health companies with IT strategy, IT system implementation, and IT compliance services.

Essentially, I help companies use technology to optimize business performance, satisfy compliance requirements, and get to market faster.

With early stage companies,

• I work with management teams to align corporate strategies and timelines with the necessary IT systems and applications.
• In life sciences, technology and IT systems are an afterthought but with some planning, life sciences companies can gain a competitive advantage by planning ahead to use these systems to meet company objectives and satisfy compliance requirements thereby reducing execution and compliance risk.

With later stage companies,

• I guide and drive system selection, system implementation, and computer validation to optimize operational performance and, once again, satisfy compliance requirements.
• I’m usually brought in during Phase 3 in preparation for commercialization.
• If the company is preparing to go public (whether through IPO or SPAC), I am brought in to select and implement financial systems and operationalize IT activities and governance to support SOX.

For those companies seeking to meet compliance requirements,

• I perform vendor audits for SaaS, software, and other IT services companies.
• I also perform internal IT audits to help life sciences companies assess readiness for regulatory inspections and identify and recommend actions to remediate gaps.
• I work with companies to operationalize their IT governance. This can be SOX, GxP, or GDPR. Management controls don’t do any good unless they integrated into the daily operations of an organization.

I work with all functional areas to understand their business needs and points and identify the appropriate solutions. The functional areas include:

• Clinical
• Regulatory
• Quality (QA /QC
• Finance/Accounting
• Human Resources
• Facilities
• Supply Chain / Manufacturing
• IT
• Medical Information
• Engineering
• EH&S

I’ve worked on GxP, 21 CFR Part 11, SOX, and GDPR projects and am familiar with Annex 11.

In essence, if a company knows they need to put in a system or is struggling with some business and/or compliance processes, I would be happy to talk to them.

Need Some Help? Not Sure if You Do?

Feel free to reach out if you have any questions or want to learn more. I can be reached by email at terri.mead@solutions2projects.com. To learn more, visit our website at Solutions2Projects, LLC.