QUALITY is key for product development success and should be at the forefront of what your company stands for. We offer flexible and supportive packages to help you find the optimal solution. GO now, GROW alongside us, and manage your QMS like a PRO from today, to ensure great QUALITY!
We offer three different packages to help you create and implement your own Quality Management System for pharmaceuticals or medical devices/in vitro diagnostics, compliant with EU, US and CH guidelines and regulations.
GO
QMS Structure Compliant: ✔️
Document implementation: You1
Technical Documentation*: Hourly rate2
Mock Audit / Self Inspection: Optional5
Hours of Initiation Training: 4
Length of Plan: One-off
eQMS System (see below): Optional
GROW
QMS Structure Compliant: ✔️
Document implementation: Collaboration
Technical Documentation*: 150 hours3
Mock Audit / Self Inspection: 1 Mock Audit
Hours of Initiation Training: 8
Length of Plan: 12 months
eQMS System (see below): Optional
PRO
QMS Structure Compliant: ✔️
Document implementation: Collaboration
Technical Documentation*: 700 hours4
Mock audit / Self Inspection: 2 Mock Audits
Hours of Initiation Training: 16
Length of Plan: 24 months
eQMS System (see below): Optional
1 Cross reference matrix provided, we can offer support on an hourly rate basis.
2 Additional cost per hour is CHF 200.
3 Additional cost per hour is CHF 175.
4 Additional cost per hour is CHF 150.
5 A mock audit of 8 hours would cost CHF 1,600.
* We will send you a monthly report of the hours you have used to ensure you make the most of them. Once the contract time period has ended, the unused hours cannot be carried forward.
To upgrade from one package to another, any costs already paid for the previous QMS package will be carried forward to allow you to upgrade to a package which offers you more support.
To prepare a product for manufacturing and sales, processes need to be established, implemented, and maintained via a risk-based approach. These processes allow for testing of the product against the specifications during verification testing and against user requirements during validation. Our team takes care of all these steps and can support in a lean and effective way.
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Risk-based process management generates lean, risk-aware processes for sustainable procedures and easy integration into existing process landscapes. We offer a modular and flexible approach to process management.
Process management includes maintenance and effectiveness measurement. The latter is underpinned by a QMS. HEMEX can support you in implementing measures and novel forms of analytics to manage implemented processes.
We support you in the Verification of your product. Whether in writing the plans, executing the testing, analyzing the results or reporting on the outcome, our team are experts in mechanical and dimensional testing. In case you are short on manpower, our team can support you in the management, organization and hands-on support during verification testing of your device.
Validation testing against user requirements usually comes in the form of a summative usability study. We can support you in the organization, planning, and reporting on the results and outcomes. In the case that you are planning on conducting the validation testing externally, we can support you in the communication and organization of external usability testing organizations and manage sample request, re-supplies, and study timing.
Measuring equipment and processes need to be installed and checked against fixed parameters. Our team can support you with the organization, management, planning, execution and reporting of all qualification work needed to allow your newly manufactured products manufactured to reach the market.
Our support can be on-site, remote or at the Contract Manufacturing Organization (CMO), depending on your demands and supply chain.
We provide services in the following:
