Elevate Program
Elevate Program
Elevate – Your raw materials partner in IVD manufacturing
The ever-changing diagnostics regulatory requirements are becoming more stringent, as in the introduction of IVDR in the European Union. IVD assay developers and manufacturers globally are anticipating future regulatory changes by leveraging raw material suppliers that can not only provide high-quality products but also the expertise and documentation to support manufacturing needs. Our new Elevate program gives IVD manufacturers the confidence needed to enter a more stringently regulated landscape with products that meet the high standards including documentation that will suffice for audit-readiness.
The Elevate program supports customers globally and includes regular additions to the approved product list. Products that are chosen to participate in the program will have an MQ segment of 300 or higher along with enhanced quality and documentation attributes as shown in the table below.
IVD Audit-Readiness Benefits provided by the Elevate Program
- Verified process control for all products within the Elevate program
- Aligned with M-Clarity™ segments
- Audit access availability with experienced technical service, if requirements are met
- Audit-ready documentation (CoA, Dossier, IFU, etc.)
- Quick turnaround time in responding to inquiries and providing necessary documentation for manufacturer’s needs
- For additional benefits, see M-Clarity™ matrix
Elevate Dossier is available upon request
In the Dossier, you will be provided information on:
- Site Quality Survey self-assessment
- ISO 9001 certificate
- Product Specifications
- Declarations / Statements (animal origin content, latex content, BSE/TSE, phthalates, RoHS, etc.)
Pack Size | ||||
|---|---|---|---|---|
1 x 5 mL ampule |
|
| 48934-U | 46885-U |
50 mL bottle | 49376-U | 48171-U | 48912-U | 46878-U |
400 mL bottle | 49377-U |
| 48914-U | 46879-U |
2.0 L bottle |
|
| 48915-U |
|
3.6 L bottle | 49378-U |
| 48917-U | 46883-U |
15 L pail | 49379-U |
|
|
|
17 L pail |
|
|
| 46884-U |
18 L pail |
|
| 48918-U |
|
91.7 L drum (110Kg) | 49380-U |
| 48919-U |
|
You asked, Merck listened
The Elevate seal should assure you of product quality. Here’s the meaning behind the design:
- Mountain ranges go from low to high showing our elevation in high quality products and services.
- The check mark, in both the mountain range and negative space, represents the verification and scrutiny the products will go through to make sure the proper documentation and support is ready for customer audits/needs.
- The three peaks indicate our ever-extending offering within the Elevate program
Quality standards and attributes for MQ300 Level and Higher materials in the Elevate program
Discriminating Attributes | Elevate Raw Materials |
|---|---|
Quality Standards | ISO 9001 |
Specifications Available | ✓ |
Certification of Quality or Certificate of Analysis available | ✓ |
Release testing- performed using established protocols | ✓ |
Written SOP for process control | ✓ |
Enhanced Change Notification | ✓ |
Site quality self-assessment available | ✓ |
Physical audits can be requested by customer | ✓ |
Product can be added to the Quality Agreement | ✓ |
Quality declarations as required by regulation or product application | ✓ |
Process control verified | ✓ |
Supplier approval by paper audit and questionnaire | ✓ |
Supplier approval by on-site audit for critical suppliers, as applicable | ✓ |
Shelf-life/Expiration date is defined by stability study | ✓ |
Intended Use Statement. For Manufacturing Use | ✓ |
Compliance Certificate REACH, RoHS, Conflict Materials, Animal Origin, etc. | ✓ |
Product can be added to Pricing & Supply Agreement | ✓ |
Country of Origin identified | ✓ |
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