PROJECT:

SITE:

PROJECT No.:

SCOPE:

DOCUMENT No.:

Sample Recorder URS

ISSUE
DATE
PURPOSE
PREPARED BY
CHECKED BY
APPROVED BY

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INDEX

1.0 Introduction
2.0 Overview
3.0 Operational requirements
3.1 Functions
3.2 Data
3.3 Interfaces
3.4 Environment

4.0 Constraints
5.0 Lifecycle
5.1 General
5.2 Testing
5.3 Deliverables
5.4 Tools
5.5 Training
5.6 Post-acceptance Support
6.0 Glossary

Appendix 1 Configuration Data

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1.0 INTRODUCTION:

1.1 General

The following document forms the User Requirement Specification for the supply of a
fully configured High Integrity Data Recording system which is to be used to provide an
independent record of process stream sterilisation within the xxx plant at xxx .

This system is primarily required to accept analogue signals from existing field
transmitters which are currently inputting to a Kent K90 Control System .A small
number of additional new signals are to be accomodated.

A primary requirement is to provide all necessary documentation to facilitate full

compliance with GAMP 4.

This document has been prepared by xxx to meet requirements of xxx

This document’s purpose is to enable formal order to be processed through to

completion of Installation Qualification of equipment by vendor.

Reference documents are as follows:-

xxx User Requirement Specification

xxx Standard for Electrical Equipment supplied with Machinery or Plant.
xxx The Development and supply of Validatable Software based systems.

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2.0 OVERVIEW

2.1 General

Steam sterilisation of asceptic processing equipment is currently carried out

automatically by the Kent K90 computer located in xxx.

Sterilisation timers are started/stopped by this system depending upon individual probe
temperatures and pressures, before progressing to the next stage of operation.
Currently these signals are logged every minute upon completion of steam sterilisation.

The Discrete Monitoring system shall provide a record of automatic process plant
sterilisations independent of the existing control system.
Existing transmitters will be used to provide the 4-20 mA input signals to the new
system with existing signal loops being interrupted at the Kent interface racks and
brought out to the recording system. This ensures that the process record is independent
of the control function.

In addition three new transmitters (supplied by others) will be used to transmit signals
from Saturated Steam process lines. These new signals will also be incorporated into the
Discrete Monitoring system.

The recording system will comprise necessary quantity of electronic recorders installed
and fully wired to terminations within a purpose-built cabinet. The system will provide
an ethernet signal to a dedicated PC /Printer system (by others).

The recording system will be installed in a controlled environment proximate to the

Control system. It will be fully pre-tested and pre-commissioned by the vendor prior to
Installation Qualification within xxx.

Project objective is to provide a highly reliable, stable and secure system providing real
time display and archiveable record of critical process parameters, which shall be readily
validateable (by others) from documentation provided by vendor.

It is essential that the system is fully compliant with GAMP 4 requirements.

Compliance with FDA 21 CFR part 11 electronic records provisions is required.

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3. OPERATIONAL REQUIREMENTS.

3.1 Functions

On-demand, secure recording of data points required for the monitoring of

approximately 50 inputs from existing and new field transmitters. These inputs to be
grouped according to a number of separate functional groupings (see appendix 1)

Facility for selecting recording ‘start’ or ‘stop’ shall be independent for each of these
groups.

‘Start’ (recording) request to be automatically prompted with requirement for provision

of User I/D, Batch I/D, Start Time and Date prior to enabling ‘Start’ function .

Upon completion of recording, operator shall be able to select ‘stop data recording’ for
any particular group and shall be automatically prompted to transfer data file to a
dedicated PC (by others) for archiving and printing as required.

Reporting facility shall enable construction of reports by subgroups of the points

collected.

It shall be possible to make selection from a displayed list of recorded parameter sets to
request up to 8 datapoints to be either displayed on screen or remotely printed.

Zoom facility shall be provided to enable scaling of both process variables and time-
base.

Process units (Degrees Celsius or Bar Absolute) shall be provided for all Process
Variable records.

Archiving and deletion of datasets shall be the responsibility of the user and will be
addressed by xxx SOPs.

Facility shall be provided to copy all data to removable media (e.g. PC Datacard ) to
enable transfer to a secure location in event of failure of Ethernet communications link .

Tag/loop name descriptors shall be 20 characters long.

In event of system power failure all currently recorded data must remain secure until
power is restored. System shall continue recording data upon restoration of power and
any downtime in such recording shall be clearly identifiable.

In event of system power failure all configuration data must remain secure until power is
restored.

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Security and access levels to recorder system shall be as follows :-
Level 0 – No user limitation – view only – no start/stop capability
Level 1 – Normal/operator - view only with start/stop capability and transfer of data.
Level 2 – Supervisor/engineer – configuration access with start/stop capability and
transfer of data .

Access levels 1 and 2 shall also be applied to the PC.

3.2 Data

Data groups shall be as detailed in Appendix 1.

Sample frequency for all datapoints shall be 1 per second.

Vendor shall advise total capacity of recorded points available.

System shall automatically transfer all closed data files to PC workstation on daily basis.

System shall provide facility for reloading of archived datasets to enable review or
printing.

Datasets, when transferred shall be in a non-editable format (proprietary or encrypted) to

obviate post-event manipulation.

3.3 Interfaces

System shall be supplied with touch-screen display allowing selection of groups to be

recorded and for display of datapoints as they are collected .

System shall be supplied with Ethernet connection having File Transfer Protocol (FTP)
to facilitate transfer of data files to PC workstation .

System shall be capable of accepting a total of 72 analogue inputs from field

transmitters.

Signal level in all cases is 4 –20 mA DC developed across a 5 ohm precision resistor.

3.4 Environment

The system shall be fully robust and capable of operating in an industrial environment.

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4. CONSTRAINTS

4.1 General

The system is to be used in a Pharmaceutical application necessitating full validation to

GAMP 4 lifecycle and documentation requirements .

Delivery of fully installed and pre-tested system to xxx site is required to be no later
than xxx.

System shall be delivered operational and fully configured with datapoints and groups
and charts fully defined.

Vendor to state the normal availability of the instruments comprising the system (MTBF
data) .It is recognised that there are no requirements for high levels of availability which
would justify the provision of stand-by or back-up units.

Whilst current application does not require full capacity of 72 inputs, the system shall
provide for expansion to meet the full capacity at some later time without recourse to
modification of hardware or system software.

Vendor to advise any restraints to recording capacity in event the above-noted full input
capacity is required to be monitored.

5.0 LIFECYCLE

5.1 General

System lifecycle is to be developed fully in accordance with requirements of GAMP 4.

Nominated vendor project manager shall develop a Quality Plan and all other
documentation required by GAMP 4.

Vendor shall review xxx documentation, supplied in association with the order for the
system, for any deviations from such documentation within their supply and shall
immediately communicate such to xxx. Upon agreement of all such deviations vendor
shall complete and sign the necessary Compliance Statement.
(see Appendix B, xxx Standard xxx).
In event of any conflict existing between requirements of above xxx standard and those
of GAMP 4 , then GAMP 4 requirements shall take precedence.

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5.2 Testing

All system datapoints are to be fully tested by injection of a live signal simulating actual
process variable signals across the full range.

Factory Acceptance Testing shall be applied to complete system (recorders fully

configured and installed within purpose-built panel) prior to shipment.

Site Acceptance Testing shall be effected with system installed at xxx. This shall be a
combined exercise between both vendor and xxx personnel.

5.3 Deliverables

All deliverables shall be fully in compliance with GAMP 4 requirements These will
include, but will not be limited to the following:-

- Quality Plan.
- Functional Design Specification *.
- Hardware Test Specification.
- Configuration Test Specification.
- Installation Qualification (IQ) Specification.

*It is assumed that due to the size of the project, the Functional Design Specification
will contain the information that would normally be provided in the Hardware and
Software Design Specifications

In addition to the above requirements the following additional documents shall be

supplied:-

- General Arrangement Drawing.

- Termination Drawing.
- Certificate of Conformance.
- Operating and Maintenance Manual.
- Spares List

All deliverables shall bear Project reference number xxx.

All deliverables in final reviewed form shall be made available in electronic format.
Paper copies are acceptable for review prior to finalisation of requirements.

5.4 Tools

All standard configuration software tools shall be provided with order.

Vendor is to advise any other maintenance or configuration tools that may be necessary.

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5.5 Training

Vendor is to advise requirement for operator training .All such training shall be at xxx
site.

5.6 Post-acceptance support

Vendor shall advise any requirements that may be necessary to support xxx in
maintenance or operation of the system after completion of Site Acceptance Testing .

6.0 GLOSSARY

FAT – Factory Acceptance Testing

FTP – File Transfer Protocol
GAMP –Good Automated Manufacturing Practice
SAT – Site Acceptance Testing
SOP – Standard Operating Procedure

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