Doc: ps2001-5-1101-001 Rev: R02. 00



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PS2001-5-1101-001-URS
1486357009-URS, URS
2.3.2
Regulations, legislation and standards
Section 3.2 and 4.10 list the various regulatory, legislative and required standards that are to be applied to the hardware and software respectively.
2
GxP is a general term for good … practice, where the x stands for various things, manufacturing, distribution, laboratory, clinical, engineering, c.

Doc PS Rev Rb
Background to the Project
The Practical Series of Publications has, for sometime, had a partially developed set of standard library modules that have been used on various projects in the past. The advantage of using (and reusing) these modules on various projects has been established and well understood. Over recent years, there has been an increasing amount of such projects being undertaken and with the increasing size of the projects it has been decided that these partially developed modules should be expanded to include a full range of process modules and that modules should be formally structured into a software module library and this will be called the Practical Series Automation Library (or PAL. There has been an increasing amount of pharmaceutical work in recent years and the necessity to reduce testing time and costs within these projects has been recognised, to this end the Practical Series Automation Library software module will be fully tested and validated and removing the need for the extensive design and documentation stages and the formal testing stages This will already have been done (and written) as part of this Project and will be issued in verifiable form by this Project.
2.5
Scope and limitations
The Practical Series Automation Library of software modules will be developed as part of this Project. The scope of this development will be limited in this Project to just the Controller software, it will not include a library of supervisor control and data acquisition system (SCADA) or human machine interface (HMI) graphical objects. The software will be written to interface with such system in a common manner, but the SCADA and HMI system will not be developed as part of this Project (though it is envisaged that this development will take place in a future project. The PAL software will be validated to the GxP requirements that are applicable to the United Kingdom at the time of writing.


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