Visibility and control for medical device manufacturers.
You need compliance and the written proof of it for every part you make and label in Medical Device. From design to packaging, you need to have everything recorded for auditable control of your work. Once you put a job on the shop floor, you need to control the work, right down to every step in the process. Quantum enforces quality, directs accurate workflow and delivers compliance at every stage of production.
We have more than 25 years of experience ensuring that medical device companies have the Production Control they require for compliance. Maintain all of your certifications including 21 CFR part 11 with a platform that's ready to install today and use tomorrow.
Complete material and tool compliance.
From original Engineering, through revision control and auditable records of work and approvals, Quantum has you covered.
Create part-specfic Bill of Materials (BOMs) for each part and ensure that the proper materials are available at each stage of production.
Comply with each equipment requirement for each customer with controlled work paths for each part on your shop floor and certification of Operators.
Correct each production non-conformance and push automated rework routines to the proper place along with approval of each piece of rework.
Get an automated eDHR with a record of every piece of work that was done on every serialized part from the original Engineering through to every Operator that touched the part in production including in-production inspection records and supervisory sign-offs.
Not just visibility.
Visibility and control. Only with Quantum.
You compete in the most rigorous field of compliance. On paper, this is next to impossible. Many manufacturers turn to Microsoft for help. Access databases are not controlled and will not give you the compliance you require.
Medical Device manufacturers need a complete auditable record of every piece of work they do, from the moment the Order is placed to the placement of the label on each part, carton and shipping box. Many manufacturers use common programs and specialized label-makers to get there. An approach like this does not give you the seamless process control you need for a proper eDHR.
Our Quantum Production Control platform gives you everything you need to get your parts compliant in both production and labeling.
Quantum gives you everything you need to get your job done on-time and compliant to the most rigorous standards of industry. Complete Production Control for Production Operations in medical device manufacturing.