Quality Management Systems
- Input from QMS stakeholders is crucial during QMS design in order to maximize QMS-effectiveness and stakeholder “buy-in”.
- QMS operators need user-friendly turnkeys to unlock and efficiently run the system.
- Truly effective QMS processes are based on gold-standard practices that functionally address the letter and intent of QMS regulations and standards. It’s not enough to just read the regulations and copy them into procedures.
- Procedures should be written to simultaneously meet FDA and ISO 13485 requirements.
- Interdependent subsystems must be seamlessly integrated (like Risk Management and Corrective Action) to assure systemic continuity.
- QMS processes need to be strategically installed in the right order to reduce everyone’s frustration and to avoid wasted time.
These are some of the core principles that ComplianceAcuity uses when we assist you with your FDA or ISO 13485 QMS. Click on a link below to review the QMS solutions about which ComplianceAcuity is most passionate:
Corrective & Preventive Action (CAPA)
Design Controls / Product Development
Production and Process Control
“…ComplianceAcuity has added considerable value to our company by helping us understand any gaps in our compliance to FDA QS Regulations. Additionally, ComplianceAcuity was able to help us implement practical solutions to bring us in line with best practice. This was demonstrated by our recent FDA audit where previous issues identified by the FDA had now been recognized as being completely addressed....”
"...One of the areas in my work to develop company systems with ComplianceAcuity I found most useful was to build a system and then review it with you in detail. This was a terrific help to assure not only that the system was compliant, but attention was paid to providing the answers to an auditor before they are asked..."
"...Your services were customized to the specific needs and constraints of our company instead of providing a canned process that did not fit our business model or intended QMS...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS..."
“…ComplianceAcuity is the 4th regulatory consultant I have used over the years. By far he has been head and shoulders above the others for the following reasons: 1) Expertise with regulations. Others did not have the breadth and depth of his expertise. 2) Quality of his solutions and ability to tailor to our firm as opposed to other consultants who used 'template-based' solutions. 3) Kevin himself is highly intelligent which enables him to quickly understand our products and processes to enable him to provide appropriate solutions the first time. This is a rare ability. 4) His personal commitment to our company was as high as any of our or our own employees. For example, he made various personal sacrifices to ensure our firm was as best prepared as possible for our recent FDA audit…”
“…Like many companies, we know “our business” but the intricacies of developing, implementing, and maintaining an effective medical device quality system was beyond our expertise (as illustrated by our recent inspection) and it was too late to gain traction on the project alone. Kevin and his Associates at ComplianceAcuity from day one had a unique ability to pull conflicting parties together within our organization. ComplianceAcuity defined the scope of the problems at hand, compartmentalized the project into understandable components, developed a realistic game plan, and worked one-on-one with our staff to bring our organization into compliance…”
“…Kevin's work style was logical and well-thought out making him easy to work with. The project turned out better than expected. Kevin is able to explain complex issues in an easy to understand way...”
“…After a series of unsuccessful FDA inspections resulting in a Warning Letter, ComplianceAcuity was hired to help resolve our longstanding issues. ComplianceAcuity clarified the problems and provided professional solutions where prior consultants, one of which was an “ex-FDAer”, did not. Because of ComplianceAcuity’s services, we were better prepared and achieved a positive outcome when FDA performed a follow-up inspection…“
“…ComplianceAcuity built a foundation for Design Controls that carry forward to the current time which has made the whole design control effort more sustainable with current head count level. This was chiefly done by mapping the requirements to the final product testing effort...”
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