Do You Need a Quality Management System Consultant?
Are you looking for simple solutions to your quality management systems and QA challenges? We understand. You are busy with your day job, and you need some help. It may be a big project, or a little one. Take a step forward with an expert QMS consultant.
Our Consulting Services
Explore our comprehensive selection of services that cater to a variety of needs, ensuring complete customer satisfaction. At just QMS, we focus on the fundamentals to deliver simple but compliant solutions that make sense for your business. We can provide some do-it-yourself (DIY) tools, or let us take charge and implement for you.
Implementation of Quality Management System
We can help you establish a new QMS, whether it is pharmaceutical quality management system, medical device QMS o life science ISO 9001 system.
We are familiar with Part 11, 21 CFR Part 210 and 211, 21 CFR 820 (both Quality System Regulation and the new Quality Management System Regulation or QMSR), ISO 9001, ISO 13485 and more.
Gap Assessments
Do you need a gap assessment vs. a new regulation like QMSR or standard like ISO 14971:2019? We have a quality management system consultant who can help.
Commissioning, Qualification and Validation
We offer facility, equipment and process validation services for life science, medical device and pharmaceutical companies. We have experience with facility commissioning, cleanroom qualification, cleaning validation, equipment IQ OQ PQ, and process validation following cGMP requirements.
Program and Project Management
Are you looking for program and project management support for new product development or quality system improvements? We have experience managing new product development following stage-gated process and design controls. We can also manage smaller projects for process improvements or CAPAs.
eQMS
Are you considering an electronic quality management system or eQMS? We have experience with simple electronic solutions like Dropbox and SharePoint, to enterprise eQMS like MasterControl. Our extensive knowledge of cGMP, quality systems and document control provide a solid foundation for electronic quality system system implementation.
Auditing
We offer internal and supplier quality system audit services, both remote and on-site audit options. We can also perform mock FDA inspections and coaching for teams to prepare for FDA inspections.
CAPA
Do you need help with CAPAs? Many companies get overwhelmed with CAPAs and need help to initiate, investigate, implement and close CAPAs. We can use our quality management system consultant expertise to help.
Training
We love training! We offer online training and on-site options. We can customize our training for your company
Documentation
Sometimes you need help with documentation, whether it is remediation of design history file or FDA 483 audit observations, to writing new SOPs and forms. We’ve done it all, so we can help here too.
Meet The Experts
We are a passionate team with over 40 years of combined experience at dozens of medical device, pharmaceutical and life science companies across the U.S.
Michael Bubien
Michael is a Pharmaceutical / Medical Device consultant with over 20 years of industry experience and extensive knowledge of FDA, ISO, MDD, IVDD, CMDR and ICH requirements in both quality assurance and validation engineering roles.
Kathleen Miller
Kathleen is a results-driven consultant with over 20 years experience in Quality Systems and Quality Assurance (QA) across the GxP biotechnology, life science and medical device sectors. She is an expert trainer and experienced quality management representative.
