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MAQS

MERCODIA ASSAY QUALITY SYSTEM

MAQS is a 69-point program developed at Mercodia to explore and explain the high quality of our assays. All Mercodia ELISAs are MAQS certified, meaning that you can put your trust in that the assay you´ve ordered fulfills stringent quality requirements.

Well trained and engaged personnel

The engagement level of the personnel at Mercodia is very high and is encouraged by management. It is a key factor when implementing improvements and Mercodia is constantly trying to optimize the work flow in all tasks performed through:

1. Recruitment of competent personnel

2. Top training and competence evaluation according to ISO

3. Engagement of employees

4. An activity plan for nurturing openness within the organization that stimulates creativity and passionate employees

ISO 13485 certified

5. Mercodia is an ISO certified company encompassing the scope: “The design, development, manufacturing and marketing of immunoanalytical in vitro diagnostic reagents, used for detection of analytes in areas such as: cardiovascular disease, obesity and diabetes. Technical support and assistance.”

Independent quality department

6. The Quality Department operates independently of other departments (such as R&D and Production). 

The Quality Department is responsible for internal audits as well as audits at supplier sites.

Standardized processes

7. To ensure that Mercodia maintains high quality in all its processes at all times, Mercodia has Standardized Operating Procedures describing all processes in detail at all levels.

  • Management
  • Developing new products
  • Manufacturing including QC
  • Marketing and sales
  • Purchasing
  • Order & Shipping
  • Human resources
  • Services
  • Life-cycle computerized systems
     
Product life cycle management

8. Mercodia has a process of managing the entire lifecycle of a product from inception, through engineering design, to manufacture and service of products.

The Product Life Cycle Management includes:

9. Design and development

10. Production

11. Quality control

12. Stability

13. CAPA (Corrective And Preventive Actions), in which interventions are being made to eliminate deviations that have occurred and in addition to this, interventions are made for prevention of deviations based on risk analyses

14. Design change

15. Standardized procedure

Ensured producability

Several Mercodia quality processes ensure reproducibility.
 

 

16. Implemented product design process, called Mercodia Product Development Model.

17. Secured product transfer to production.

18. Validated production processes.

Reagent control

19. Raw material is categorized in three levels with different levels of control.

Level 1 materials are defined as critical reagents (antibodies and antigens) which require thorough evaluation of the supplier using a “supplier questionnaire” in which the quality management system is evaluated, and audit is performed when necessary. During the production process, reagents are QC tested according to a standardized control method before release. 


Level 2 includes generic, but critical reagents from key suppliers with documentation being reviewed and reagents QC tested before release.


Level 3 includes “off the shelf”-products, which are not critical for the performance of the assay but are released against specified criteria.

Traceable assay calibration

To ensure that the results obtained by Mercodia assays are accurate and comparable to the reference.

20. Traceable calibration of antigen. Mercodia strives to trace all calibrators to an international approved reference standard when possible.

21. Mercodia is an active participant in different harmonization projects. 

22. Reference calibrators are produced from reference material with concentrations matching the assay range.

23. Up to four different preparations of reference stock solution are prepared in parallel.

24. After statistical evaluation, preparations that are within acceptable variation are pooled and diluted to reference calibrator concentrations.

25. The concentrations of prepared kit stock solution are determined by the use of the reference calibrators.

26. Kit calibrators produced from the stock solutions are controlled against reference calibrators.
 

Going above and beyond guarantee

Not letting ‘good-enough’ be good enough for our customers.

27. The same product development model is the basis for each new product regardless of species or regulatory status.

28. Pre-diluted calibrators, color-coded reagents, and user-friendly protocols.

  • Prevents inaccuracy in individual dilutions.
  • Minimizes handling errors.
  • Ensures accurate results at each laboratory.
Well documented product design

Design History File (DHF)

29. All aspects of product design are documented and filed for easier evaluation and control.

30. Design and development planning - includes project planning documentation.

31. Design Input - includes user requirement specification and technical specification for the product.

32. Design Output - includes technical reports from the development process, project phase reports and the Device Master Record (DMR) for the product.

33. Design Review - includes records from documentation review and design review meetings.

34. Design Verification - includes plans and reports connected to the design verification of the product.

35. Design Validation -includes plans and reports connected to the design validation of the product.

36. Design Transfer - includes documentation connected to the transfer of the product from Development into Production.

37. Design Changes - includes documentation of any change in the assay design performed after the Final Design of the product has been set.

38. Protocols - includes records from meetings connected to the development project.

Thorough product validation

Every new product is thoroughly validated by design verification, which ensures a continuously high quality with regards to sensitivity, precision, accuracy, specificity and fulfilment of intended use. Industry standards such as EMA, FDA and CLSI and ISO are used as guidance and specified for each product.

The design verification is an integral part of product development and includes:

39. Recovery upon addition or dilution linearity are investigated   

40. Recovery upon dilution or parallellism are investigated 

41. Selection and verification of the calibrator curve fitting model

42. Precision studies (repeatability within assay run and repeatability between runs)

43. Homogeneity over the plate 

44. Cross reactivity and interference of relevant substances 

45. Limit of detection

46. Hook effect 

47. Robustness (e.g. incubation time, temperature, washing procedure, shaker speed)

48. Antigen stability

Sensitivity testing following industry guidelines

There are a variety of methods used for determining assay sensitivity. For easier evaluation and comparison of product specifications, Mercodia always states which method was used when assay sensitivity was determined.

Sensitivity is tested in two different ways:

49. Analytical sensitivity (also called capability of detection/detection limit). Used as part of a method validation, and does not describe the lowest concentration to be accurately measured

50. Functional sensitivity. Lower Limit of Quantification (LLOQ) is the lowest concentration at which an analyte in a sample can be determined, with acceptable precision and accuracy.

Precision testing for every product

An ELISA sensitive to changes in the assay environment or production conditions will contribute to a high interassay variation. Both the intra- and interassay variations are dependent on user handling and overall performance of the assay.

 

51. Precision is monitored and presented as:

  • Repeatability (within assay variation)
  • Within laboratory (total assay variation)
Stability data for all products

Stability studies are performed according to a standardized procedure for all components and kits produced by Mercodia and include:

52. Real-time stability

53. Stressed stability (accelerated)

54. Transport stability

55. Follow-up stability

56. Open-reagents stability

A defined validation process

57. Ensures quality of the product through validation of production processes and includes:

  • Equipment
  • Reagents
  • Suppliers
  • Computerized systems
  • Analytical methods
  • Lot-to-lot comparison between production batches
Complete maintenance of DMR for each product

58. Device Master Records (DMR) are documents needed to produce a product for sale, divided in three levels:

  • Raw material
    • Production
    • Purchase specifications
    • Methodology journal
  • Components
    • Production methods
    • Specifications and acceptation criteria
    • Composition of components
    • Process specifications
    • Production environmental specifications
    • Labelling
  • Kit
    • Production methods
    • Control method
    • Specification and acceptance criteria
    • Kit composition
    • Labelling
    • Directions for use
Complete maintenance of DHR

59. Device History Record, DHR verifies that a product lot has been produced according to the product’s DMR and includes:

 

  • Raw materials
  • Components
  • Kit composition
  • Directions for Use
Flexible production organization

60. Production plans can be adapted to meet changes in market demands. 

Proprietary plate coating process

61. The Mercodia proprietary coating process ensures coating of all wells with defined quality.

62. 96-well plate edge-effect testing

  • This assures that the wells on the edge of a Mercodia plate do not differ in accuracy compared to wells away from the edge, a common phenomenon in average/generic ELISAs. 

63. Homogeneity testing

  • Defined specification and acceptance criteria for all products
  • Defined protocol for testing homogeneity of the plate
  • Ensures low total variation across the plate and across batches
Best possible assay performance

64. To ensure best possible kit performance assays are developed with:

 

  • Monoclonal antibodies (ensures high specificity, high affinity, accessibility to the specific antibodies over time and minimal lot-to-lot variations)
  • Direct-conjugated detection antibody to ensure low background
  • Optimization to prevent matrix effects, interferences from substances in the sample
  • Easy to use components, to minimize handling errors
Traceability from raw material to end user

65. The manufacturing of each kit component can be traced all the way back to its raw material by thorough documentation at every level:

 

  • Distribution
  • The DHR for each lot number secures information about:
    • Production date
    • Production materials
    • Amount produced
    • Amount released
    • References to standard operating procedures
    • Quality records
    • Labelling of products
Marketing integrity guarantee

66. All products and services of Mercodia are promoted in a trustworthy, honest and transparent fashion. 

Customer support guarantee

67. Dedicated and qualified tech-support staff are available to answer any technical inquiries within 24 hours with the sole aim of supporting the customer until the problem is solved.

Tech support and complaint handling are located “under the same roof” at Mercodia's headquarters, allowing close collaboration with Production, Quality, R&D, and Sales & Marketing, ensuring the best support for our customers.

Post-market surveillance

68. Each product is monitored using post-market surveillance.

 

  • The performance of the product is continuously monitored both from customer communications and from Mercodia in-house use.
  • Customer input is important for fulfilling our commitment for post-market surveillance.
  • Standardized protocol for follow-up on adverse events.
Fast, validated and realible shipping

69. Next day shipping via FedEx at room temperature has been tested and deemed safe for delivery.