This document outlines the user requirements for a new moisture analyzer model BVC. It will be used in quality control labs to determine moisture content of samples. The analyzer must meet 19 user requirements related to functionality, design, and documentation. Key requirements include utilizing halogen heating, weighing and displaying results in grams, drying samples from 30 seconds to 480 minutes, and complying with ISO quality standards. The analyzer will ensure accurate moisture testing in support of quality control.

1. Company Name
User Requirements Specification for Moisture Analyser Model BVC
Edition: 1.00
Page 1 of 5
User Requirement Specification for Moisture analyser
Moisture Analyser
Equipment Number : 01234
Applies to Supersedes -
Matrix : 695
Section : - Copy no. -
References :
User Manual for Moisture analyser Model XXCXCC.
Operation Instruction for Moisture analyser Model XXCXCC (Document number : 12345).
USP Reference standards. Identification A, B Loss on drying.
Prepared by department no.: XXX
Validation Improvement Specialist
(date) Fatima Grangeiro Landim (FGL)
Reviewed and Approved by:
Quality Control Labs Manager
(date) QC Manager
Quality Assurance
(dato) Quality Assurance Officer (Initial)
(date)

2. Company Name
User Requirements Specification for Moisture Analyser Model BVC
Edition: 1.00
Page 2 of 5
Table of Contents
1 Purpose and Scope ............................................................................. 3
2 Responsibilities .................................................................................... 3
3 Definitions and Abbreviations ............................................................... 3
4 Equipment Description ......................................................................... 3
5 Design Requirements........................................................................... 4
5.1 User Requirements ....................................................................... 4
5.2 Functional Requirements .............................................................. 4
5.3 Non-critical general requirements ................................................. 5
6 Documentation and Regulation ............................................................ 5

3. Company Name
User Requirements Specification for Moisture Analyser Model BVC
Edition: 1.00
Page 3 of 5
1 Purpose and Scope
This URS details the requirements of the Moisture Analyser
(Model XXCXCC) which will be used purpose to determine
moisture contents of test samples.
The moisture analyser will be used routinely within the QC labs at
room 14, building 20 at the Company LLLL.
Moisture content analysis is a critical component of material
quality and essentially a function of quality control in the
Company LLL within the QC laboratory.
This is a controlled document. Additional copies are obtained
through the issuing company authority. In the event of copying
locally, mark each document with a stamp “Uncontrolled copy”.
2 Responsibilities
Initials Department Responsibility Title
FGL QC Microbiology dept. Author Validation
Number XXX Specialist
XXX QC Microbiology dept. Approval QC Manager
Number XXX
XXX QA dept. Number XXX QA Approval QA Officer
3 Definitions and Abbreviations
Abbreviation Full text/ Explanation
URS User Requirement Specification
VMP Validation Master Plan
SOP Standard Operating Procedure
USP 30 LOD U.S. Pharmacopoeia <731> Loss on drying
URS User Requirement Specification
4 Equipment Description
The moisture analyser will be routinely used within QC labs to
determine moisture contents of test samples. Components of the
moisture analyser are described below:

4. Company Name
User Requirements Specification for Moisture Analyser Model BVC
Edition: 1.00
Page 4 of 5
Description Purpose
Display and graphic user guidance. To ensure error-free usage.
An automatic drawer and a sample holder. To make routine work easier.
To ensure Optimal testing
Aluminium sample pans (90 mm X 90mm).
conditions.
Printer and Printer papers (set of five rolls and self
adhesive paper set of 3 rolls. To print results.
5 Design Requirements
The Moisture analyser must meet the following design
requirements.
References Requirements
U1 The moisture analyser should utilise a halogen heating module.
U2 The moisture analyser must have an RS232Port.
The moisture analyser must have a foot print of no greater than 40cm X
U3
15cm X 40cm.
5.1 User Requirements
The Moisture analyser must meet the following User
Requirements.
References Requirements
U4 The moisture analyser must be able to weigh in units of grams.
U5 The moisture analyser must display/print moisture loss in grams.
U6 The moisture analyser must display moisture and dry contents in %.
The moisture analyser must have a drying time range of 30 seconds to 480
U7
minutes.
U8 The moisture analyser must have Reusable sample pan.
U9 The moisture analyser must be able to store a maximum of 10m methods.
U10 The moisture analyser must be able to print GLP / GMP-compliant printouts.
5.2 Functional Requirements
The Moisture analyser must meet the following Functional
Requirements:

5. Company Name
User Requirements Specification for Moisture Analyser Model BVC
Edition: 1.00
Page 5 of 5
References Requirements
U11 The moisture analyser should have a resolution capability to 0.1mg.
The moisture analyser should have a maximum sample weighting of
U12
81g.
The moisture analyser should have a minimum sample weighting of
U13
0.1g.
U14 The moisture analyser must have a temperature range of 40-200 °C.
5.3 Non-critical general requirements
In accordance with the Validation Plan Document number XXX,
compliance with these requirements shall be verified during
installation Qualification at the QC labs. Refer to Validation Plan
Document number XXX for further qualification tests.
6 Documentation and Regulation
The moisture analyser requires the following documentation.
References Requirements
The moisture analyser should have a maintenance , operational
U15
manual , logbook for the equipment and a troubleshooting manual.
U16 The moisture analyser must comply with Quality certificate ISO 9001.
Environment certificate ISO 1400 Temperature adjustment set, HA-
U17
TCC
The moisture analyser. traceable test certificate) 214528 40 °C to
U18
200 °C
U19 Certified adjustment weight 50 g (Class F1) 11119530

6. Company name
User Requirement Specification for Moisture Analyser Model BVC
Edition: 1.00
Page 1 of 1
Change History
Edition Effective date Description of change Revised without
changes
Date / Sign.
1.0 January 2011 Initial version