Client References – QMS & Engineering Projects
QMS Process Improvement/Audit & Certification
Audit Types: FDA * CE Mark * MDSAP
Michael Furtaw, Ph.D – Director of R&D (Biotechnology)
LI-COR Biosciences
“We recently updated our Image Studio – 21CFR11 software package and wanted to confirm the validation package would enable our customers to meet FDA compliance and provide a robust level of documentation.’
‘We brought Advantu’s experts on board. Included in their analysis, they conducted assessments of LI-COR’s recent database upgrade to ensure it was in perfect alignment with FDA’S 21 CFR Part 11 regulations. Advantu’s expert, Ron Kutsch, performed the inspection, which yielded a terrific peace of mind that we were enabling full compliance.’
‘Ron’s final report included recommendations that were clear and made it very easy for us to implement, which we accomplished in short order. Again, having Advantu’s vote of confidence gave us what we needed.’
‘We are very pleased with the results and recommend Advantu to any biotech or biopharma company who needs expert support for their engineering, quality, and regulatory compliance needs.’”
Steve Speers – Quality Systems Manager
Synthetic Genomics, Inc.
“We wanted to add a new DNA Synthesis Instrument to our GMP workflow, so we brought Advantu’s Process Experts on board to conduct the appropriate analysis, develop the plan and spearhead the implementation.’
‘I wholeheartedly recommend them for any Quality Process support you may need.'”
Adam Sampson – VP of Product Excellence
IRRAS, Inc.
“During preparation for our GMED CE Mark regulatory submission, we enlisted Advantu to conduct a Design History File (DHF) gap analysis and ensure critical elements were remediated to the Medical Device Regulation (MDR) standard.’
‘With poise and balance, while under duress and an incredibly tight timeline, Advantu admirably delivered more than expected. Advantu is rigorous, thorough, and offers a broad array of templates, best practices, and skill sets to uplevel a Quality Management System (QMS).’
‘We highly recommend Advantu for any Quality & Engineering needs.'”
Julie Woolf – COO
The Argen Corporation
“During our preparation for an MDSAP Audit, we reached out to Advantu to conduct a gap analysis for our software validation process to ensure we had everything in place for a successful audit.’
‘Advantu’s thorough assessment and remediation assistance allowed us to ensure Argen was fully prepared and in doing so, enabled us to pass the MDSAP Audit with no software validation findings.’
‘We highly recommend Advantu for any Quality & Software Validation needs.'”
Nancy Hegdahl – Quality Manager (North)
Hawkins, Inc.
“We wanted to update and improve our Intended Use Validations at Hawkins for both COTS and custom developed applications.’
Included in this effort was the Electronic Signature (21CFR Part 11) validation of our internally developed system supporting our QMS.
‘We brought Advantu’s Process Experts on board. They quickly conducted assessments of several Hawkins systems and efficiently identified Intended Use Validation (IUV) gaps that needed to be resolved in support of our validation efforts.’
‘Additionally, we were provided a plan of action to close the identified gaps.’
‘Advantu’s team was extremely professional, knowledgeable and enjoyable to work with. Their deliverables were completed professionally and provided the foundation for the next steps in our IUV process.’
‘We look forward to our continued relationship with Advantu’s experts.'”
Software Quality Engineering/Test
Kevin Hughes – Director of Software Engineering
Modular Medical, Inc.
“As a startup company, efficiency and expertise are critical to our success. We partnered with Advantu as part of our commitment to product and software quality. Advantu’s team and incredible network of experts were able to consistently deliver value and help shape the way we developed our product.’
‘Advantu helped us refine not only our software practices, but our whole program management approach, ensuring that we were making efficient use of limited resources while creating business and customer value.’
‘I recommend Advantu for any medical device company looking to strengthen their quality, test, or program management capabilities.'”
Shawn Sanders – Program Manager
Accriva Diagnostics/IL
“Advantu provided a team for software quality engineering, technical writing & hardware test support, for multiple ongoing projects.’
‘Advantu’s team enables AD to meet their project commitments in order to accomplish goals for milestones and scheduling demands successfully.'”
Mike McAndrew – Director, Program Management
Oxford Immunotec
“Advantu provided a team for software quality assurance and testing support, including quality engineering (regulatory) support for an FDA submittal.’
‘Advantu’s team enabled OI to meet the stringent FDA demands for a successful submittal.'”
Don Canal – Executive Team
Clarify Medical
“Advantu provided resources for software quality assurance and testing support for a Medical Device & Physician/Patient Portal interface system.’
‘Clarify was able to successfully release their product with the highest quality and reliability.'”
Troy Molsberry – Senior Architect
PacketSled/MixMode
“I’ve had nothing but great experiences working with Kris and his Advantu Team, and he is absolutely correct in stating that he was able to efficiently get us the performance scaling solution we needed.”
