This document outlines the user requirements for a pH meter Model BVCFTR. It specifies 31 requirements across various categories such as design, functional, documentation, and support needs. The pH meter will be used in quality control labs to measure the pH of solutions from 2 to 12. It must store calibration data, display readings accurately, and include documentation and a warranty. The requirements aim to ensure the pH meter meets the lab's needs for accurate and reliable pH measurement.

1. Company Name
User Requirements Specification for pH meter Model BVCFTR
Edition: 1.00
Page 1 of 6
User Requirement Specification for pH Meter
pH Meter Model BVCFTR
Equipment Number : 01234
Applies to Supersedes :
Matrix :
Section : Copy no. :
References :
User Manual for pH Meter Model BVCFTR.
Operation Instruction for pH Meter Model BVCFTR Document number: 12345.
USP References - General Chapters <791> pH.
European pharmacopeia,2,2.3: Potentiometric determination of pH.
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
(date) Quality Assurance Officer (Initial)
(date)

2. Company Name
User Requirements Specification for pH meter Model BVCFTR
Edition: 1.00
Page 2 of 6
Table of Contents
1 Purpose and Scope ............................................................................. 3
2 Responsibilities .................................................................................... 3
3 Definitions and Abbreviations ............................................................... 3
4 Process and Equipment Description .................................................... 3
5 User Requirements .............................................................................. 4
5.1 Design Requirements ................................................................... 4
5.2 Functional Requirements .............................................................. 5
6 Documentation and Regulation ............................................................ 5
7 Support ................................................................................................ 5

3. Company Name
User Requirements Specification for pH meter Model BVCFTR
Edition: 1.00
Page 3 of 6
1 Purpose and Scope
This URS details the requirements of the pH Meter (Model BVCFTR) which will
be used for the determination of the pH of solutions over the approximate range
of pH 2 to pH 12.
The pH meter will be used routinely within the QC labs at room 14, building 20
at the Company LLLL.
The further qualification activities for the pH meter will be documented in IQ/OQ
and PQ protocols. The qualification of the pH meter will include qualification of
the temperature accuracy, voltage accuracy, pH accuracy, sign/noise ration and
further testing.
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 U.S. Pharmacopoeia
4 Process and Equipment Description
The degree of acidity or alkalinity of a substance is determined by pH
measurement. The QC labs routinely measure the acidity or alkalinity of
samples and substances, and accurate pH measurement are essential in a
number of different routine situations within the QC Labs.

4. Company Name
User Requirements Specification for pH meter Model BVCFTR
Edition: 1.00
Page 4 of 6
Some of the equipment features are described below:
1. High-contrast display with large characters for easy readability
2. RS232 interface as standard;
3. Choice of print formats (Short / Standard / GLP);
4. Sample ID;
5. Sensor ID;
6. User ID;
7. Data storage (1000 measurements / 400 calibrations / 40 methods);
8. Multilingual (English / German / French / Spanish);
9. Function that enables the time and date to be included on the printout;
10. Electrode holder;
5 User Requirements
The pH meter must meet the following User requirements.
References Requirements
URS1 Must store at least 4 calibration points.
Must calculate and display asymmetry and slope values of the calibration
URS2
curve.
URS3 Alert Alarm, if occur a power failure and /or calibration data is lost.
URS4 Large, backlit display showing clearly all relevant information.
URS5 Date/time and sensor and sample ID fully recorded for each measurement.
To be able to document user ID and sensor serial number for each
URS6
measurement.
The user interface displays menu and system settings as well as all error
URS7
messages and warnings.
URS8 The electrode (s) must be suitable for use in a pH range between 0 and 12.
5.1 Design Requirements
The pH meter must meet the following Design requirements.
References Requirements
URS9 Must display pH to 0.001 pH units.
URS10 Must have a footprint of no more than 0.6m².
URS11 Must display a temperature to 0.1°C.
URS12 The electrode must include a temperature sensor.
URS13 All electrodes must have serials numbers permanently attached.
URS14 Must operate using a 220-240V, 50-60 Hz power supply.
URS15 Must have an interface data output to an external printer or software system.

5. Company Name
User Requirements Specification for pH meter Model BVCFTR
Edition: 1.00
Page 5 of 6
References Requirements
All the electrodes used in the PH meter must have serial number and the
URS16
name of the manufacturer on them.
Measurement of the zero point of the electrode shall appear on the body of
URS17
the electrode.
5.2 Functional Requirements
The pH meter must meet the following Functional Requirements:
References Requirements
Accurate temperature measurement must be within ± 0.02 pH units at 25°C
URS18
for the calibration curve.
URS19 Reproducibility of pH measurement must be within ± 0.02 pH units at 25°C.
URS20 Accurate temperature measurement to ± 0.5 °C between 20°C and 25°C.
6 Documentation and Regulation
The pH meter requires the following documentation.
References Requirements
URS21 * Manufacturer Manuals (operation & Maintenance).
URS22 Manufacturer Quality Documentation.
URS23 Declaration of conformity.
URS24 All calibration certificates.
URS25 Manufacturer is an approved QA company supplier.
URS26 Technical Specifications.
All documentation supplied by supplier/manufacturer must also contain
URS27
information about the electrodes and buffer solutions.
URS28 List of recommended spare parts.
* The content of the equipment manuals must meet the acceptance criteria of
this User Requirement and further Qualification activities shall be
included/executed/ and documented in order to verify whether the equipment
manufacturer supply the user with Appropriate information, and if there is
consistency between documentation.
7 Support
References Requirements
URS29 Minimum 12 months warranty.

6. Company Name
User Requirements Specification for pH meter Model BVCFTR
Edition: 1.00
Page 6 of 6
References Requirements
Spares and accessories (pH electrode, buffer sachets, field case, probe,
URS30
etc).
Supplier must provide service and repair for the pH meter (training in how to
URS31 use the pH meter should be supplied by manufacturer/vendor).

7. Company name
User Requirement Specification for pH meter Model BVCFTR
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