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

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PS2001-5-1101-001-URS
1486357009-URS, URS

4.10.3 Maintenance and publication of verification certification
Environmental requirements 4.11.1 Physical security (1) The Controller will be located within a lockable electrical panel, see § 3.1-(6) 4.11.2

4.10.2
Software standards
(1) The Practical Series Automation Library software will be written to the standards set down in the
International Electrotechnical Commission
(IEC) publication 61131-3: Programmable controllers - Part 3: Programming languages, listed here as
[Ref. 008]
4.10.3
Maintenance and publication of verification certification
(1) The software library
will
be validated and
will
be fully GMP compliant (see § 2.3.1). The details of the validation process are given in the Validation Plan (VP,
[Ref. 002]
(2) The completed verification documents (e.g. test specification, calibration certificates, c)
will
be made available as secure documents that clearly identify the software module and its version number. Each document will be complete with signatures and all attachments.

66-71 Doc PS Rev Rb
Environmental requirements
4.11.1
Physical security
(1) The Controller will be located within a lockable electrical panel, see § 3.1-(6)
4.11.2
Software security
(1) The software within a particular Controller
will
have the facility to be password protected, this is a function of the Controller and the TIA Portal programming environment) The released, validated modules within the software library
will
not be password protected in anyway, the purpose of the software is that it is a reusable library and will be deployed on new projects as they arise, the software thus, needs to be accessible.
(3) The storage of the released (validated) version of the software library in its entirety
will
be protected on the company servers, the software
will
be downloadable at the current released version (along with its documentation, this
will
be a read-only process. The software library
will
be under change control management (CCM) and only authorised personnel
will
be able to modify the software.

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