ProcessControlSystemsGAMP5SoftwareCategories

1、Pr ocess Con trol Systems GAMP 5 Software CategoriesIn the article Validati on Determ in ati on the use of categoris ing software was discussed and how this can support the app roach to the validati on. In this p ost we are look ing at types of software which fall in to these categories for P rocess

2、 Con trol Systems / Automati on Systems.Categoris ing software is used to support the app roach to the validati on based on comp lexity and no velty of the compu terised system.The categories detailed withi n this p ost are based on GAMP 5 Software Categories.1.GAMP Software Category 1-Infrastructur

3、e SoftwareUn less a very simp le con trol system (PLC and HMI) there is likely to be some eleme nts of in frastructure software.In frastructure software in its most sim pie form is the op erat ing system which the app licati on software resides.Additi onal software for managing the in frastructure t

4、he p rocess con trol system in cludes:Op erat ing SystemsAn ti-virus SoftwareActive Directory / Doma in Con troller Database Software (SQL / Oracle) Server and Network Hardware Virtual En vir onmentsFirewalls, in clud ingcon figurati on Server and Network Mon itori ng Tools Back up Systems2.Note: In

5、 frastructure should be built, con figured and depIo yed in accorda nee with defi ned p rocess / p rocedure and critical asp ects and / or con figurati on verified. In frastructure is qualified but not validated. The validatio n is p erformed on the hosted app licati on not on the in frastructure.GA

6、MP Category 3-Non Con figurable SoftwareCon figuratio n relates to add ing fun cti on ality through sta ndard modules, library items to sta ndard software app licati ons to meet the bus in ess requireme nts.In a p rocess con trol system a DCS would be con figured from sta ndard modules to con trol a

7、 sp ecific p rocess and would fall un derGAMP Category 4. An electr onic chart recorderwhich is also con figured with Input Ran ges, Alarm Set poi nts, etc. would fall un der GAMP Category 3 for while it is has p arameters en tered un der the con figuratio n it does not defi ne fun ctio nality or a

8、p rocess flow.It is imp orta nt to un dersta nd the disti nction betwee n true con figurati on and p arameterisati on whe n assig ning the category.Other exa mp les that would fit un der GAMP category 3 would be systems that are p rovided with compu terised con trollers, i ncludi ng P rogrammable Lo

9、gic Con trollers (PLC app licati on is not modified (although may be p arameterised) to meet the bus in ess n eed. Within the p harmaceutical in dustry there are many exa mp les of these in cludi ng Labelli ng and P ackag ing equipment.There is no fixed rule as to the validati on app roach for GAMP

10、Category 3 systems. This should be comb ined with the impact or criticality of the p rocess that the system is mon itori ng and / or con trolli ng. It can support decisi ons as to lifecycle ste ps that may not n eed to be p erformed for exa mple Source Code Reviews, limited verificatio n activities

11、and greater relia nee on ven dor test docume ntatio n.As with any supp lier you should en sure that the software has bee n p erformed in accorda nee with an approp riate quality man ageme nt system. However the GAMP Category can support the decisi on as to the level of supp lier assessme nt that n e

12、eds to be p erformed (Po stal Questi onn aire rather tha n Full Site Audit.EU Annex 11 states that the n eed for an audit should be based on a risk assessme nt refer to the Validati on Determ in ati on p ost.3.GAMP Software Category 4-Con figured SoftwareCon figured software for a p rocess con trol

13、system is software app licati ons that are con figured to meet sp ecific bus in ess n eeds (see above GAMP Category 3).GAMP Category 4 -Configured Software range in complexity from simpie configuration of SCADA system grap hics to complex p rocess con trol within a DCS or PLC (li nking sta ndard lib

14、rary objects to con trol the p rocess).Exa mp les of con figurable software for a P rocess Con trol System in eludes: DCS / SCADA Mimics DCS / SCADA Databases (Alarms, Tags, History) PLC / DCS p rograms con figured from Sta ndard fun ctio ns library / IEC61131-3For GAMP Category 4 software the app r

15、oach to the compu ter systems validati on may be to use the supp lier' s docume ntati on and verificati on to dem on strate the suitability of thestandard modules and limit the re gulated company ' s verification to the critical functions of the bus in ess p rocess and functions to support r

16、egulatory comp lia nee (security, electro nic records, etc.).4.GAMP Software Category 5- Bespoke SoftwareBes poke software is software that is gen erally writte n from scratch to fulfil the bus in ess n eed. As this software is going the full devel opment lifecycle there is a higher level of risk of

17、 errors within the app licati on code.In terms of a P rocess Con trol System GAMP Category 5 software may range from PLC logic (Ladder, Seque nee Flow Chart, C+, etc.) to custom scri pts writte n within the SCADA / DCS system.As GAMP Software Category 5 the level of verification through software tes

18、t ing (FAT, SAT, IQ, OQ, etc.) will be in creased. The level and formality of p erform ing and docume nting this testi ng will be determ ined on the GMP Impact (P roduct Quality, P atie nt Safety, Data In tegrity and GMP regulatory requireme nts).5.SummaryThe Validati on Determ in atio n can be used

19、 to ide ntify each component of the system and the associated software category(s).The GAMP Software Category may be used to support Compu ter Systems Validatio n decisi ons which may be docume nted within the Validati on Determ in atio n Stateme nt or within the Validati on Plan.The GAMP Category c

20、an also be used to support further risk assessme nts, for exa mple con sider the type of software category for con trolli ng / mon itori ng each fun cti on. The likelihood of failure or the failure going un detected may be lower for less complex / novel software.(comments: I find the ,parameterizati

21、on? vs. ,configuration? distinction in the article interesting. Iguess another way of putting the distinction is Category 4 =“ some assembly required ” whereCategory 3 is “WYSIWYG, correct?I?ve person ally found that such fine par sing of defi niti ons in an atte mpt to make a dist inction p robably

22、 means there isn?t any clear differe nee betwee n the two. I kno w, I knowsay ing“the sky is blue.and“ differe nces betwee n GAMP s/w categories is blurry” is sort of like say ingtrying to beg the questi on of the n ecessity of eve n making the disti ncti on.IMO, various FDA-regulated companies spen

23、d an awful lot of time tryi ng to defi ne a uniq ue-to- each-GAMP-category validati on strategy that tends to not add real value to en suri ng objective evide nee exists that GMP/CTQ requireme nts have bee n met. I nstead, we create rather complex systems of docume ntati on where, whe n we recog niz

24、e the workload required to satisfy our Validati on Franken ste ins, we begi n to use mental sca nning electro n microsc opes in an effort to defi ne today?s system to be validated as bel onging to the lowest nu mber category po ssible thus relieve us of some work.I remember an automati on engin eeri

25、 ng man ager from a p revious job telli ng me, really, there are just three categories of software/automati on/co mpu terized systems: -Non-con figurable / non-p rogrammable-Con figurable- only (i.e., whether ,p arameterized? or ,con figured?)-Con figurable and ProgrammableHis ultimate point was tha

26、t all the categorizati on tends to do is p rovide a gross idea as to the compi exity and poten tial immediate impact the software has on your p articular pro cess. I tend to agree. The GAMP Category that your compu terized system / software fits should n?t dictate what you do for validati on so much

27、 as just give you a gross no ti on of the compi exity of validati ng the system.In the end, you n eed to dem on strate that you meet your GMP/CTQ requireme nts. That a system is Cat 3 or Cat 5 does n?t cha nge the n ature of the requireme nt. Whether you validate a bes poke p rocess con trol system you assemble and p rogram or buy some COTS-p arameterizable-only system that both happen to seem in gly meet your requi