USER REQUIREMENT SPECIFICATION FOR CHEMICAL INSTRUMENTS

Introduction:

This User Requirement Specification (URS) defines the requirements for the selection, procurement, installation, qualification, and use of chemical instruments intended for [your organization/laboratory/production facility]. The purpose of this document is to establish a clear understanding between the end users, the Quality Assurance (QA) department, Engineering, and potential suppliers regarding the expectations and functional requirements for these instruments.

Chemical instruments covered by this URS may include, but are not limited to:

• Analytical instruments (e.g., Gas Chromatographs, High Performance Liquid Chromatographs, UV-Visible Spectrophotometers)
• Measuring devices (e.g., pH meters, conductivity meters)
• Sample preparation systems
• Supporting software for data acquisition, processing, and reporting

These instruments will be used to support critical operations such as:

• Raw material analysis
• In-process testing
• Finished product testing
• Method development and validation
• Regulatory compliance testing

This document provides a basis for:

• Evaluating and selecting suitable equipment and vendors
• Ensuring compliance with applicable regulatory and industry standards (e.g., GMP, GLP, 21 CFR Part 11)
• Guiding design, installation, qualification, training, and maintenance activities

The URS forms part of the overall validation and procurement lifecycle. It is expected that all stakeholders review, comment on, and approve this document to ensure that the selected instruments meet the operational and compliance needs of [your organization].

1. User Requirement Specification for AHU
2. User Requirement Specification for KF final
3. User Requirement Specification for Water Purification System
4. User Requirement Specification for Walk In Stability Chamber
5. User Requirement Specification for Melting Point Apparatus
6. User Requirement Specification for Viscometer
7. User Requirement Specification for Vacuum Oven
8. User Requirement Specification for UV-VIS Spectrophotometer
9. User Requirement Specification for UV- Visible Spectrophotometer 1
10. User Requirement Specification for UV Spectrophotometer 2
11. User Requirement Specification for Top Pan Balance
12. User Requirement Specification for Tap Density Tester
13. User Requirement Specification for Stability Chamber
14. User Requirement Specification for Stability Chamber 1
15. User Requirement Specification for Sieve Shaker
16. User Requirement Specification for Semi Micro Balance
17. User Requirement Specification for Refrigerator
18. User Requirement Specification for Refrigerated Water Bath
19. User Requirement Specification for Refractometer
20. User Requirement Specification for Refractometer 1
21. User Requirement Specification for Potentiometer
22. User Requirement Specification for Polarimeter
23. User Requirement Specification for pH Meter
24. User Requirement Specification for pH meter 1
25. User Requirement Specification for Online TOC
26. User Requirement Specification for Offline TOC final
27. User Requirement Specification for Melting Point Apparatus
28. User Requirement Specification for Melting Point Apparatus 1
29. User Requirement Specification for Liquid Particle Counter
30. User Requirement Specification for LOD Oven
31. User Requirement Specification for KF Apparatus
32. User Requirement Specification for HPLC
33. User Requirement Specification for HPLC Grade Water Generation System
34. User Requirement Specification for HPLC
35. User Requirement Specification for HPLC (3)
36. User Requirement Specification for GC
37. User Requirement Specification for GC 1
38. User Requirement Specification for Fume Hood
39. User Requirement Specification for FTIR
40. User Requirement Specification for FTIR Spectrometer
41. User Requirement Specification for Friabilator
42. User Requirement Specification for DT Apparatus
43. User Requirement Specification for Demineralized Water Generation System
44. User Requirement Specification for Dissolution Apparatus
45. User Requirement Specification for Conductivity Meter
46. User Requirement Specification for Bursting Strength Tester
47. User Requirement Specification for Autotitrator
48. User Requirement Specification for Autotitrator 2
49. User Requirement Specification for Auto Karl Fisher Apparatus
50. User Requirement Specification for Analytical Balance
51. User Requirement Specification for Analytical Balance 1