Process Control Systems GAMP 5 Software Categories January 21, 2013 2013|| Software Validation, Validation , Validation Articles | Articles | 2 comments
In the article Validation Determination the use of categorising software was discussed and how this can suort the aroach to the !alidation" In this ost we are loo#ing at tyes of software which fall in to these categories for $rocess %ontrol Systems & Automation Systems" %ategorising software is used to suort the aroach to the !alidation 'ased on comle(ity comle(it y and no!elty of the comuterised system" )he categories categories detailed within this ost are are 'ased on on *A+$ Software Software %ategories"
GAMP Software Category 1 – Infrastructure Software -nless a !ery simle control system .$/% and +I there is li#ely to 'e some elements of infrastructure software" Infrastructure software in its most simle form is the oerating system which the alication software resides"
Additional software for managing the infrastructure the rocess control system includes • • • • • • • • •
erating Systems Anti4!irus Software Acti!e Directory & Domain %ontroller Data'ase Software .S5/ & racle Ser!er and 6etwor# ardware Virtual 7n!ironments 8irewalls, including con9guration Ser!er and 6etwor# +onitoring )ools :ac#u Systems Note: Infrastructure should 'e 'uilt, con9gured and deloyed in accordance with
de9ned rocess & rocedure and critical asects and & or con9guration !eri9ed" Infrastructure is ;uali9ed 'ut not !alidated" )he !alidation is erformed on the hosted alication not on the infrastructure"
GAMP Category 3 – Non Congurale Software %on9guration relates to adding functionality through standard modules, li'rary items to standard software alications to meet the 'usiness re;uirements" In a rocess control system a D%S would 'e con9gured from standard modules to control a seci9c rocess and would fall under GAMP Category !" An electronic chart recorder which is also con9gured with Inut
s where the alication is not modi9ed .although may 'e arameterised to meet the 'usiness need" ?ithin the harmaceutical industry there are many e(amles of these including /a'elling and $ac#aging e;uiment"
)here is no 9(ed rule as to the !alidation aroach for *A+$ %ategory 3 systems" )his should 'e com'ined with the imact or criticality of the rocess that the system is monitoring and & or controlling" It can suort decisions as to lifecycle stes that may not need to 'e erformed for e(amle Source %ode
GAMP Software Category ! – Congure" Software %on9gured software for a rocess control system is software alications that are con9gured to meet seci9c 'usiness needs .see a'o!e *A+$ %ategory 3" *A+$ %ategory @ %on9gured Software range in comle(ity from simle con9guration of S%ADA system grahics to comle( rocess control within a D%S or $/% .lin#ing standard li'rary o'Bects to control the rocess" 7(amles of con9gura'le software for a $rocess %ontrol System includes • • •
D%S & S%ADA +imics D%S & S%ADA Data'ases .Alarms, )ags, istory $/% & D%S rograms con9gured from Standard functions li'rary & I7%C113143 8or *A+$ %ategory @ software the aroach to the comuter systems !alidation may 'e to use the sulier>s documentation and !eri9cation to demonstrate the suita'ility of the standard modules and limit the regulated comany>s !eri9cation to the critical functions of the 'usiness rocess and functions to suort regulatory comliance .security, electronic records, etc""
GAMP Software Category 5 – #es$o%e Software
:eso#e software is software that is generally written from scratch to ful9l the 'usiness need" As this software is going the full de!eloment lifecycle there is a higher le!el of ris# of errors within the alication code" In terms of a $rocess %ontrol System *A+$ %ategory software may range from $/% logic ./adder, Se;uence 8low %hart, %, etc" to custom scrits written within the S%ADA & D%S system" As *A+$ Software %ategory the le!el of !eri9cation through software testing .8A), SA), I5, 5, etc" will 'e increased" )he le!el and formality of erforming and documenting this testing will 'e determined on the *+$ Imact .$roduct 5uality, $atient Safety, Data Integrity and *+$ regulatory re;uirements"
Summary )he Validation Determination can 'e used to identify each comonent of the system and the associated software category.s" )he *A+$ Software %ategory may 'e used to suort %omuter Systems Validation decisions which may 'e documented within the Validation Determination Statement or within the Validation $lan" )he *A+$ %ategory can also 'e used to suort further ris# assessments, for e(amle consider the tye of software category for controlling & monitoring each function" )he li#elihood of failure or the failure going undetected may 'e lower for less comle( & no!el software"
