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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 personel

The engagement level of the personal at Mercodia is very high and is encouraged by the 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 evaluation

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 with 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 in-house 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 and manufacture, to service and disposal of manufactured 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. Change control

15. Standardized procedure

Ensured producability

Several Mercodia quality processes ensure reproducibility.
 

 

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

17. Secured design transfer to production.

18. Validated production processes.

Reagent Control

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

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


Level 2 is generic but critical reagents from key suppliers that is controlled for specification criteria, tested by QC using a standardized control method before release and supplier questionnaire.


Level 3 is “off the shelf”-products, which are not that critical for the performance of the assay but is controlled for specification criteria.

Traceable assay calibration

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

20. Standard Calibration of antigen. Mercodia strives to trace all calibrators to an international approved reference standard when available.

22. International calibrators are produced from the international reference material with concentrations matching the kit calibrators.

23. Up to four different preparations are made in parallel of international stock solution.

24. The preparations that are within acceptable variation are pooled and diluted to international calibrator concentrations

25. The concentrations of prepared internal stock solution and internal calibrators are determined by the use of the international calibrators.

26. Kit calibrators produced from the internal stock solution are controlled against the internal calibrators.
 

Going above and beyond guarantee

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

27. Same thorough process of product development for each product regardless of regulatory status.

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

  • Prevents inaccuracy in individual dilutions.
  • Prevents handling mistakes.
  • 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 assures it will keep a continuously high quality over its life-time with regards to sensitivity, precision, accuracy, specificity and to assure 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 done continuously during the development of a product and includes:

39. Parallelism and dilution linearity                                                                

40. Optimization of the calibrator curve fit and selection of the best model to use, determining the dynamic range i.e. LLOQ (lower level of quantification) and ULOQ (upper level of quantification)

41. Precision study (repeatability within assay run)

42. Precision study (repeatability between runs)

43. Homogeneity over the plate

44. Cross reactivity and interference of important substances

45. Sensitivity testing

46. Hook effect

47. Robustness (time, temperature, washing procedure, shaking)

48. Antigen stability

Sensitivity testing following industry guidelines

There is 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 witch 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 inter assay variation. Both the intra and inter assay variations are dependent on user handling and overall performance of the assay. Therefore:

 

51. Precision is monitored and presented as:

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

The stability of a reagent is defined as preserving its specified characteristics and performance within a specific time-frame.

Stability studies are done 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. Bench-top stability

57. Open-reagents stability

A defined validation process

58. Ensures quality of the product through validation of production process and includes:

  • Equipment
  • Reagents
  • Suppliers
  • Computerized systems
  • Analytical methods
  • Lot-to-lot comparison between three production batches to show:
    • Consistent precision
    • Consistent level of analyte without level-dependent differences
    • No sample specific differences
Complete maintenance of DMR for each product

59. 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

60. 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
Proprietary plate coating process

61. The Mercodia proprietary coating process ensures coating of all wells with defined quality, leading to very high homogeneity over the plate.

62. 96-well Plate Edge-effect Testing.

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

63. Homogeneity Testing

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

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

 

  • Monoclonal Antibodies (assures highly specificity, high affinity, and accessibility to the specific antibodies over time).
  • 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. All parts of a kit can be traced through every process back to its raw material with thorough documentation at every level:

 

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

66. All products and services of Mercodia is always 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 located at Mercodia head quarter with close collaboration with production, QA and R&D and marketing and sales, ensures the best support “all under one roof”.

Post-Market Surveillance

68. Every product, from launching until discontinuation, is covered by the system post-market surveillance.

 

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

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