Siri H. Segalstad’s Quality Assurance and LIMS FAQ

Due to the general lack of a resource dedicated to answering frequently asked questions about Quality Assurance, Laboratory Information Management Systems (LIMS), Validation, Supplier Audits, and the like, I decided to compile this FAQ. I hope you find it useful and if you have your own question that you’d like to see added to the list, please don’t hesitate to ask using the form on the bottom of this page. Thanks.

  1. Rating: +1

    How do we handle a new Computer System project?

  2. Rating: -1

    How is the project organized?

  3. Who is in the Project team, and what do they do?

  4. Rating: +0

    What does the Project leader do?

  5. Who are Project members in the project team?

  6. What is the Sponsor team / Owner group?

  7. What does Quality Assurance Unit / QA do in the project?

  8. How do we organize a live system?

  9. Rating: +1

    Why write the URS?

  10. What is a User Requirements Specification?

  11. What is included in the URS?

  12. Which suppliers receive the URS?

  13. How do we assess the answers from the suppliers?

  14. What is a Functional specification?

  15. What is risk?

  16. Rating: -1

    What is the difference between Validation and Qualification?

  17. What is the purpose of a Validation plan?

  18. Rating: +1

    What does a Validation plan include?

  19. What is a Validation report?

  20. What is included in a qualification and the qualification plan?

  21. How do we write test plans?

  22. How do we write the Qualification report?

  23. What is DQ?

  24. What is IQ?

  25. What is OQ?

  26. What is PQ?

  27. What is the purpose of a traceability matrix?

  28. What is a Supplier/Vendor Audit?

  29. What is the purpose of a supplier audit?

  30. Rating: -1

    How do we prepare for a supplier audit?

  31. Rating: +1

    How is the audit done?

  32. Rating: -1

    What is included in the supplier audit report?

  33. Which standards and regulations exist for computerized systems?

  34. Which standards are mandatory in the pharmaceutical industry?

  35. Rating: -1

    Which standards apply to the hospital industry?

  36. Which standards are used by environmental labs?

  37. Which standards are used by testing and calibration labs?

  38. Rating: +2

    What is the difference between certification and accreditation?

  39. Rating: +2

    How do we create a Quality Management System (QMS)?

  40. What are SOPs?

  41. How do we write an SOP?

  42. Which SOPs are needed for a computer system?

  43. What is 21 CFR Part 11?

  44. Which technical requirements are there in 21 CFR Part 11 for an IT system?

  45. Who needs to comply with Part 11?

  46. How do we do 21 CFR Part 11 training?

  47. How do you get a 21 CFR Part 11 compliant system?

  48. Rating: -2

    What is LIMS?

  49. Rating: -1

    What is static data?

  50. Rating: +3

    What is dynamic data?

  51. Can we build our own LIMS?

  52. Rating: -1

    Which LIMS is the best?

  53. Is it safer to choose the old and well-known suppliers instead of the new suppliers?

  54. What does LIMS cost?

  55. How do we implement or configure LIMS?

  56. Rating: +3

    What is a BMS / HVAC system?

  57. How do we handle Lab Instruments?

  58. How do we qualify the sample holder?

  59. How do we qualify the injector?

  60. How do we qualify the detector?

  61. How do we qualify the column?

  62. How do we qualify the column oven?

  63. What type of accessories (spares) used to operate bms system for hvac.

  64. IS vendor / supplier certification is Acceptable by regulatory bodies for Operational qualification?

  65. How can we prepare a common framework for assessing the risk score of each functions stated in the functional specification document. ?

  66. who are will be conduct the internal audits?

  67. what is bms and hvac

  68. Please explain what are the important works that a PL do? and how perform in a unique way.

  69. difference between monitoring and surveillance

  70. What is the bms system.

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