Hatlestad Consulting is a trusted partner that helps emerging life science companies bring life changing products from concept to consumer, efficiently and effectively.
Scott Hatlestad
Founder & President
Quality First
Embracing a culture of continuous improvement, seeking feedback from clients and stakeholders, and actively implementing innovative approaches to enhance the quality and value of our services.
Our Services
21 CFR Part 11 / Annex 11 Compliance and Assessments
21 CFR Parts 210/211/820 compliance
Business Continuity and Disaster Recovery
Change Control
Computer System Validation (CSV) / Computer Software Assurance (CSA)
Computerized System Supplier Quality Audits
Corrective Action / Preventive Action (CAPA)
Data Integrity Governance & Strategy
Data Migration
Electronic Clinical Trial Systems
– Trial Master File (eTMF)
– Patient Reported Outcome (ePRO)
– Data Capture (EDC)
– Interactive Response Technology (IRT)
– Clinical Trial Management Systems (CTMS)
– Clinical Outcome Assessments (eCOA)
GxP Training
Inspection Readiness
Internal Audits
IT Governance
Management Review
Periodic Review
Process Improvement
Product Serialization / Track & Trace
Project Management
Quality and Regulatory Systems
– Learning Management Systems (LMS)
– Electronic Document Management Systems (EDMS)
– Regulatory Information Management Systems (RIMS)
– Quality Management Systems (QMS)
Quality Compliance and Remediation
Quality Strategy and Oversight
Quality Systems ISO 9001 and 13485 Certification Readiness
Risk Assessment and Risk Management
Technical Writing
– Polices
– Procedures
– Training Documentation
Test Execution
Hatlestad Consulting works with clients to define or streamline systems and processes ensuring regulatory compliance in the most efficient way possible. Helping emerging life science companies define and implement a regulatory framework that ensures compliance with US and international regulations with minimal resources. Effectively streamlining the framework systems to minimize the friction of going to market while identifying, prioritizing and implementing solutions or proving alternatives as necessary.
Proficient
Embodying deep, practical knowledge combined with streamlined approaches to navigate the complexities of life science regulations and quality assurance. We don’t just understand the regulations, we translate it into clear, actionable solutions that empower your business to thrive.
Personalized
We tailor our regulatory compliance and quality assurance solutions to the unique needs and challenges of each life science client, exceeding industry standards with laser-focused expertise and unwavering guidance.
Thorough
Unwavering scrutiny represents our relentless commitment to detail. We leave no stone unturned in our pursuit of regulatory compliance and quality assurance, applying deep expertise and comprehensive methodologies to meticulously analyze every aspect of your life science operations. This uncompromising thoroughness is the bedrock of our service and the foundation of your success.
Collaborative
We believe compliance excellence isn’t achieved alone. Bridging expertise signifies our commitment to combining our deep regulatory knowledge with your unique company context and challenges. Building compliance together underscores our collaborative approach, where we partner with you, not just advise you, to navigate the regulatory landscape and build a robust quality assurance system.
Critical Thinking
It’s about pushing beyond the surface to identify potential risks, uncover hidden complexities and arrive at the most effective solutions for our clients.
The life sciences industry is a complex and highly regulated landscape. Bringing a new product or medical device to market requires navigating a labyrinth of regulations, from pre-clinical studies to manufacturing and post-market surveillance. This is where Hatlestad Consulting comes in.
We are the champions of agility in a world of inertia. We understand that the life science landscape is constantly evolving, and so are we. We are nimble and responsive, adapting our approach to meet the ever-shifting regulatory tides and the dynamic demands of your business.
We are the storytellers of quality. We translate the complex language of regulations into actionable insights and practical guidance, empowering your team to own and embrace the quality culture. We believe that everyone, from the lab bench to the boardroom, has a role to play in building a culture of excellence.
Process-Driven Expertise
Building solutions based on a deep understanding of relevant process principles, regulatory guidelines and industry best practices.
Collaborative
& Partnership-Oriented
Fostering open communication and collaboration with clients, building trust and shared ownership of success.
We believe that compliance is not a destination, but a continuous journey of improvement and innovation. We partner with you, shoulder-to-shoulder, mind-to-mind, to build robust quality systems that are not just compliant, but inherently great. We are here to work together in developing trust-worthy validated systems and processes that scale with your growth and brand framework.
HATLESTAD CONSULTING 2024
Scott provides a great depth of knowledge across a wide array of GxP and Computer Validation subjects. I appreciate his pragmatic, risk-based approach, and his dedication to working WITH the team and accomplishing the task at hand. He has been a welcomed addition.
Jason M
Senior Director, Regulatory Systems, Info & CS Validation
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Hatlestad Consulting has been vital contributor to my team helping implement a wide variety of GxP QA projects including systems validation, data migration and supplier qualification audits. The projects are always well executed and have resulted in a decrease of CAPAs and Deviations with an increase in overall compliance. I’ve relied on Scott Hatlestad for not only his critical thinking but the valuable insight he has provided in terms of regulatory interpretation and industry best practices.
Jeff A
Executive Director Quality Management and GxP Systems
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When it comes to the rapidly ever-changing demands on Drug Development including having regulated compliant electronic systems, no one is more versed than Scott. Having worked with him over a decade, he has always met our challenging/changing timelines, provided great solutions, delivered service that meets or exceeds our expectations. His work was used as evidence during multiple successful FDA inspections!
Jeff O
Vice President Quality Assurance
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I have worked with Scott for close to ten years. His understanding of GxP, SOX, computer systems validation, quality systems, strong project management skills combined with his interpersonal skills make him a very valuable and versatile asset to an organization. Providing services to a growing organization, Scott was able to wear several hats and support diverse teams and projects, ie IT, Quality, Finance. He always delivers high quality work products; team members know they will be successful with Scott as a team member. As a senior leader, I appreciate Scott’s ability to look ahead and proactively anticipate potential issues. Scott is a true asset to any organization.
Beth C
Vice President IT / CIO
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Scott is highly knowledgeable regarding computerized systems and adept at applying his knowledge to provide workable solutions. His insights and thoughtful recommendations have been key to our organization’s journey towards compliance maturity.
Lisa Y
Director, Quality Assurance
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We are HATLESTAD CONSULTING.