GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識-PPT

GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識GAMP5(GoodAutomatedManufacturingPractice)良好自動化生產(chǎn)實(shí)踐指南A

Risk

Based

Approach

to

Compliant

GxP

ComputerisedSystem遵從GxP計(jì)算機(jī)化系統(tǒng)監(jiān)管的風(fēng)險(xiǎn)管理方法2Different

Terminology不同的術(shù)語?????ComputerisedSystems計(jì)算機(jī)系統(tǒng)AutomationSystems自動化系統(tǒng)ControlSystems控制系統(tǒng)ControlEquipment控制設(shè)備DataManagementsystems數(shù)據(jù)管理系統(tǒng)ComputerisedSystem:Asystemincludingtheinputofdata,electronicprocessingandtheoutputofinformationtobeusedeitherforreportingorautomaticcontrol計(jì)算機(jī)系統(tǒng):系統(tǒng)中包括數(shù)據(jù)輸入，電子化處理和用于報(bào)告或自控的信息輸出SFDA:

Good

Manufacturing

Practice

for

pharmaceutical

products(Draft

for

comment)SFDA：藥品生產(chǎn)質(zhì)量管理規(guī)范（征求意見稿）

3

Introduce簡介GAMP5（GoodAutomatedManufacturingPractice-Rev5）GAMP是由國際制藥工程協(xié)會（ISPE）主編的實(shí)踐指南。自90年代以來，不斷改版的良好自動化生產(chǎn)實(shí)踐指南被廣泛使用并得到國際監(jiān)管部門的公認(rèn)。它是計(jì)算機(jī)化系統(tǒng)驗(yàn)證的指導(dǎo)方針。GAMP5是GAMP的第5版本。計(jì)算機(jī)化系統(tǒng)由硬件、軟件、網(wǎng)絡(luò)組件和可控的功能和相關(guān)文件組成

軟件

硬件

固件控制系統(tǒng)

操作規(guī)程與人

員

設(shè)備受控的功能與流程

計(jì)算機(jī)化系統(tǒng)4FDA(Food

and

Drug

Administration)TGA(Therapeutic

GoodsAdministration)治療產(chǎn)品管理局(Medicines

and

Healthcare

Products

Regulatory

Agency

‐

was

previously

the

MCA)

（藥品及保健產(chǎn)品管理局‐前身為藥品監(jiān)督局）EMEA(European

Medicines

Evaluation

Agency‐includes

MHRA

and

equivalents

from

otherEU

countries)(歐洲藥品管理局‐包括MHRA

英國藥管局和其它歐盟國家的對等機(jī)構(gòu))食品與藥物監(jiān)督管理局

MCC

(Medicine

Control

Council)

藥品控制委員會

-如不符合管理規(guī)定，任何人都有權(quán)拒絕。MHRANIHS(National

Institute

of

Health

Science)（國立環(huán)境健康科學(xué)研究院）HC‐SC(Health

Canada

–Sante

Canada)加拿大衛(wèi)生部SFDA

(Chinese

FDA中國的FDA)

IndustryRegulators行業(yè)監(jiān)管機(jī)構(gòu)-Regulatetoensuresafetyofdrugsthatanyofusmighttake!-通過管理保證我們?nèi)魏稳硕伎赡苡玫降乃幤返陌踩?Allhavethepowertorefuseimportsiftheirregulationsarenotmet.5US

FDA?Automated

processes.Whencomputersorautomated

dataprocessingsystemsareusedaspartofproduction

orthequalitysystem,themanufacturershallvalidate

computersoftwareforitsintendeduseaccordingtoan

establishedprotocol.Allsoftwarechangesshallbevalidatedbeforeapprovalandissuance.Thesevalidationactivitiesandresultsshallbedocumented.

自動化過程。當(dāng)計(jì)算機(jī)或自動數(shù)據(jù)處理系統(tǒng)做為生產(chǎn)或質(zhì)

量系統(tǒng)的一部分時(shí)，制造商需要驗(yàn)證計(jì)算機(jī)軟件系統(tǒng)是按

照預(yù)先設(shè)計(jì)使用的。所有軟件變更在準(zhǔn)許使用前是可驗(yàn)證

的。這些驗(yàn)證的活動和結(jié)果應(yīng)該被文檔記錄。PART

820

QUALITY

SYSTEM

REGULATION質(zhì)量系統(tǒng)規(guī)則第820部分6EMEA?Validation:Theextentofvalidationnecessarywilldependona

numberoffactorsincludingtheusetowhichthesystemistobeput,

whetherthevalidationistobeprospectiveorretrospectiveand

whetherornotnovelelementsareincorporated.Validationshouldbe

consideredaspartofthecompletelifecycleofacomputersystem.

Thiscycleincludesthestagesofplanning,specification,programming,testing,commissioning,documentation,operation,monitoringandmodifying.驗(yàn)證：驗(yàn)證的范圍基于一組包含應(yīng)用于系統(tǒng)的因素，無論驗(yàn)證是預(yù)見性的還是回顧性的，無論有無新元素的使用。驗(yàn)證應(yīng)該被認(rèn)為是計(jì)算機(jī)系統(tǒng)完整生命周期的部分。這個周期包括設(shè)計(jì)，規(guī)范，編程，測試，調(diào)試，文檔，運(yùn)行，監(jiān)控和修改。Commission

Directive

3003/94/ECAnnex

11

Computerised

system3003/94/EC調(diào)試指令附錄11計(jì)算機(jī)系統(tǒng)7大家應(yīng)該也有點(diǎn)累了，稍作休息大家有疑問的，可以詢問和交流8SFDA?Whereautomatedandmonitoringsystemsareusedforthese

applicationstheyshouldbevalidatedtoensurethatcriticalprocess

requirementsaremet.使用自動化和監(jiān)視系統(tǒng)的地方，應(yīng)該被驗(yàn)證以確保滿足關(guān)鍵過程要求Good

Manufacturing

Practice

for

pharmaceutical

products,

Part

II

Annex

(Draft

for

Comment)

Chapter

12

Terminal

Sterilisation:藥品生產(chǎn)質(zhì)量管理規(guī)范第二部分附錄（征求意見稿）第12章最終滅菌9Addition補(bǔ)充

第110條（第1次的是115條款）：使用計(jì)算機(jī)化倉儲管理的，應(yīng)有相應(yīng)的操作規(guī)程防止因系統(tǒng)故障、停機(jī)等特殊情況而造成物料和產(chǎn)品的混淆和差錯。

第164條（第1次的是172條款）：如使用電子數(shù)據(jù)處理系統(tǒng)、照相技術(shù)或其它可靠方式記錄數(shù)據(jù)資料，應(yīng)有所用系統(tǒng)的詳細(xì)規(guī)程；記錄的準(zhǔn)確性應(yīng)經(jīng)過核對。如果使用電子數(shù)據(jù)處理系統(tǒng)，只有受權(quán)人員方可通過計(jì)算機(jī)輸入或更改數(shù)據(jù)，更改和刪除情況應(yīng)有記錄；應(yīng)使用密碼或其它方式來限制數(shù)據(jù)系統(tǒng)的登錄；關(guān)鍵數(shù)據(jù)輸入后，應(yīng)由他人獨(dú)立進(jìn)行復(fù)核。用電子方法保存的批記錄，應(yīng)采用磁帶、縮微膠卷、紙質(zhì)副本或其它方法進(jìn)行備份，以確保記錄的安全，且數(shù)據(jù)資料在保存期內(nèi)應(yīng)便于查閱。來源：sFDA藥品生產(chǎn)質(zhì)量管理規(guī)范送審版第2次

2009.12.1010Purpose

目的?Costeffectiveframeworkofgoodpracticetoensurethat

computerisedsystemsarefitfortheintendeduseand

compliantapplicableregulations良好實(shí)踐的有效架構(gòu)以保證計(jì)算機(jī)系統(tǒng)是滿足使用要求和順從規(guī)章要求的?Safeguard:Patientsafety,productsquality,&dataintegrity保證條款：患者安全，產(chǎn)品質(zhì)量和數(shù)據(jù)完整?Providesuppliersguidanceonthedevelopmentand

maintenanceofthesystemsbyfollowinggoodpractice.

通過良好實(shí)踐，為供應(yīng)商提供系統(tǒng)開發(fā)和維護(hù)的指導(dǎo)11KeyConcepts12關(guān)鍵概念13求非常重要‐

basis

for

making

risk‐based

decisions.是根據(jù)風(fēng)險(xiǎn)作出決定的基礎(chǔ)End

user

SHOULD

do

the

following:最終用戶應(yīng)a)

Identify

Critical

Quality

Attributes

(CQAs)

for

their

product

during

drug

development.在藥開發(fā)過程中確定其產(chǎn)品的關(guān)鍵質(zhì)量屬性Critical

Quality

Attributes

for

a

Tablet?片劑的關(guān)鍵質(zhì)量屬性？purity,

potency,

stability…純度、效價(jià)、穩(wěn)定性…….b)

Classify

CQAs

in

terms

of

their

effect

on

patient

safety.根據(jù)其對患者安全的影響對關(guān)鍵質(zhì)量屬性進(jìn)行分類

Impact

on

Patient

Safety?對患者安全的影響？

purity,

potency,

stability

all

high

impact

純度、效價(jià)、穩(wěn)定性都具

有很高的影響

GAMP5

KEY

CONCEPTS

1-

product/Process

Understanding

GAMP5關(guān)鍵概念-對產(chǎn)品/工藝的理解

‐

fundamental

to

determining

system

requirements.

對決定系統(tǒng)要14End

user

SHOULD

do

the

following:最終用戶應(yīng)：c)

Identify

material

attributes

and

process

parameters

which

might

affect

any

of

the

CQAs確定能夠?qū)θ魏侮P(guān)鍵質(zhì)量屬性產(chǎn)生影響的的物料屬性和工藝參數(shù)e.g.

Material

Attributes

/

Process

Parameters

affecting

PURITY?

例如，能夠影響純度的物料屬性/工藝參數(shù)purity

of

the

input

materials;

temperature

of

processing;

ambient

humidity/temperature;

cleanliness

of

equipment…原材料的純度；工藝溫度；環(huán)境溫濕度；設(shè)備的潔凈度d)

Investigate

the

design

space

for

each

attribute

/

parameter

in

order

to

rate

their

criticality.

對每項(xiàng)屬性/參數(shù)的設(shè)計(jì)空間進(jìn)行研究以判定其關(guān)鍵性e.g.

How

much

can

ambient

humidity

/

temperature

vary

without

affecting

the

tablet

stability?例如，在不影響片劑穩(wěn)定性的情況下環(huán)境溫濕度的允許變化范圍是多少？

GAMP5

KEY

CONCEPTS

1-

product/Process

Understanding

GAMP5關(guān)鍵概念-對產(chǎn)品/工藝的理解15End

user

SHOULD

do

the

following:最終用戶應(yīng)：e)

Used

that

information

to

propose

a

control

strategy

for

the

process.

通過這種信息來提出工藝的控制策略。e.g.

Control

Strategy

for

Ambient

T

/

RH?

例如，環(huán)境溫濕度的控制策略？GAMP5

KEY

CONCEPTS

1-

product/ProcessUnderstanding

GAMP5關(guān)鍵概念-對產(chǎn)品/工藝的理解f)

Create

a

URS

splitting

that

control

strategy

into

individual

functions

(related

to

CPPs

and

classified

according

to

their

impact).編寫URS，將這種控制策略分配到單獨(dú)的控制功能中（與工藝參數(shù)相關(guān)并根據(jù)其影響進(jìn)行分類）。16Planningcover:計(jì)劃包含activities,Responsibility,procedures&timelines活動，責(zé)任，流程和時(shí)間表Specification:規(guī)范enablesystemtobedeveloped,verified&Maintained.Itmaybesuppliedbyasupplier使系統(tǒng)可以被開發(fā)，驗(yàn)證和維護(hù).可由供應(yīng)商提供Verification驗(yàn)證Normalcase(+vetesting),Invalidcase(-vetesting),Repeatability,Performance,Volume/load,Regression,Structuraltesting常規(guī)，非法，重復(fù)，性能，負(fù)載，不變，結(jié)構(gòu)性測試Validationreport:驗(yàn)證報(bào)告Summerisingactivitiesperformed,deviations,outstandingandcorrectiveactions總結(jié)執(zhí)行的活動，偏差，超標(biāo)和動作糾正GAMP5

KEY

CONCEPTS

2-

Life

cycle

approach

within

a

QMSGAMP5關(guān)鍵概念2-質(zhì)量管理系統(tǒng)內(nèi)的生命周期法17Tablet

manufacturing

system片劑生產(chǎn)系統(tǒng)Water

for

injection

sterilisation

system注射用水滅菌系統(tǒng)Building

management

system樓宇控制系統(tǒng)Waste

treatment

system廢物處理系統(tǒng)Ointment

mixing

vessel膏劑混合罐

214

(indirect

impact

only)僅

間接影響5

(no

impact)無影響3

GAMP5

KEY

CONCEPTS

2-

Life

cycle

approach

within

a

QMS

GAMP5關(guān)鍵概念2-質(zhì)量管理系統(tǒng)內(nèi)的生命周期法Life

cycle

activities

should

be

scaled

according

to:

應(yīng)從如下方面對生命周

期活動進(jìn)行評價(jià)：a)

system

impact

on

patient

safety,

product

quality

and

data

integrity

系

統(tǒng)對患者安全、產(chǎn)品質(zhì)量和數(shù)據(jù)完整性的影響。e.g.

Rank

these

control

systems

in

terms

of

impact:例如，根據(jù)其影響性對如下控制系統(tǒng)進(jìn)行排序：18?Underlying

operating

system

and

network

infrastructure

操作系統(tǒng)和網(wǎng)絡(luò)基礎(chǔ)架構(gòu)?Standard

package

such

as

SiemenWinCC如西門子WinCC等標(biāo)準(zhǔn)包?Firmware

such

as

PLC

如PLC等固件?Configured

element

such

as

function

Blocks

如功能塊等配置元件?Bespoke

coded

sequence,

ladder

logic,

C++

protocol

conversion,

etc

定制編碼序列、梯形邏輯、C++協(xié)議轉(zhuǎn)換等

GAMP

Category

1

第1類

GAMP

Category

3

第3類

GAMP

Category

3

第3類

GAMP

Category

4

第4類GAMP

Category

5

第5類

GAMP5

KEY

CONCEPTS

3-

Scalable

Life

Cycle

Activities

GAMP5關(guān)鍵概念3-可增減生命周期活動

Life

cycle

activities

should

be

scaled

according

to:應(yīng)從如下方面對生命周期

活動進(jìn)行評價(jià)：

b)

system

complexity

and

novelty系統(tǒng)的復(fù)雜性和新穎性e.g.

Rank

these

software

modules

in

terms

of

the

intrinsic

risk

they

pose

due

to

complexity

/

novelty:

例如，根據(jù)因?yàn)閺?fù)雜性/新穎性而具有的內(nèi)

在風(fēng)險(xiǎn)對如下軟件模塊進(jìn)行排序：19“Application

of

Quality

Risk

Management

enables

effort

to

be

focused

on

critical

aspects

of

a

computerized

system,

in

a

controlled

and

justified

manner”進(jìn)行質(zhì)量風(fēng)險(xiǎn)管理使我們能夠以受控且可以論證的方式將工作重點(diǎn)集中在計(jì)算機(jī)系統(tǒng)的關(guān)鍵領(lǐng)域。

進(jìn)行初步風(fēng)險(xiǎn)分析并確定系

統(tǒng)的影響

確定對患者安全、產(chǎn)品質(zhì)量和

數(shù)據(jù)完整性具有影響的功能

進(jìn)行功能風(fēng)險(xiǎn)分析并確定控制

方法

執(zhí)行并檢查確認(rèn)適宜的控制方

法

審查風(fēng)險(xiǎn)并監(jiān)控控制效果GAMP5

KEY

CONCEPTS

4-

Science

Based

Quality

Risk

ManagementGAMP5關(guān)鍵概念4-根據(jù)科學(xué)進(jìn)行的質(zhì)量風(fēng)險(xiǎn)管理20“Regulated

companies

should

seek

to

maximise

supplier

involvement

throughout

the

system

life

cycle

in

order

to

leverage

knowledge,

experience

and

documentation,

subject

to

satisfactory

supplier

assessment

”

“在進(jìn)行了很好的供應(yīng)商評估之后，符合監(jiān)管要求的公司應(yīng)在系統(tǒng)的整個生命周期內(nèi)盡量利用供應(yīng)商的參與以充分利用其知識、經(jīng)驗(yàn)和文件?！盙AMP5

KEY

CONCEPTS

4-

Science

Based

Quality

Risk

ManagementGAMP5關(guān)鍵概念4-根據(jù)科學(xué)進(jìn)行的質(zhì)量風(fēng)險(xiǎn)管理What

does

Austar

have

to

offer?

奧星所能提供有：Knowledge:

process

control

expertise知識：工藝控制專有技術(shù)Experience:

validating

control

systems

to

GAMP經(jīng)驗(yàn)：根據(jù)GAMP對控制系統(tǒng)進(jìn)行驗(yàn)證Documentation:comprehensive

template

documents文件

綜合模版文件

‐

planning計(jì)劃

‐

specification

規(guī)范

‐

verification

確認(rèn)

‐

reporting

報(bào)告21?Process

Owner:Thepersonultimatelyresponsibleforthebusinessprocessorprocessesbeingmanaged過程所有者：為最終生產(chǎn)或被管理的過程而負(fù)責(zé)的人?System

Owner:Thepersonultimatelyresponsibleforthe

availability,support,andmaintenanceofasystemandforthe

securityofthedataresidingonthatsystem系統(tǒng)所有者：為系統(tǒng)的可用性，支持和維護(hù)，及系統(tǒng)上數(shù)據(jù)安全性而負(fù)責(zé)的人?Subject

Matter

Expert:Thoseindividualswithspecificexpertiseinaparticularareaorfield.SMEshouldtaketheleadroleintheverificationofcomputerisedsystems.SMEresponsibilitiesincludeplanninganddefiningverificationstrategies,definingacceptancecriteria,selectionofappropriatetestmethods,executionofverificationtestsandreviewingresults領(lǐng)域?qū)＜遥涸谀骋活I(lǐng)域有某特定技術(shù)的人。SME應(yīng)該引導(dǎo)計(jì)算機(jī)系統(tǒng)的驗(yàn)證。SME責(zé)任包括計(jì)劃和定義驗(yàn)證策略，定義驗(yàn)收標(biāo)準(zhǔn)，選擇合適的測試方法，執(zhí)行驗(yàn)證測試和審核結(jié)果Key

Personnel關(guān)鍵人22Benefits

to

both

regulated

companies

&

supplier:公司和供應(yīng)商均得到的益處?Reductionofcost&timetakentoachieveandmaintaincompliance降低實(shí)現(xiàn)和維護(hù)一致性的費(fèi)用和時(shí)間?Earlydefectidentificationandresolution:reducecost,speed

早期的辨識和解決：降低費(fèi)用，提高速度?Costeffectiveoperationandmaintenance高效運(yùn)行和維護(hù)?Effectivechangemanagementandcontinuousimprovement有效的變更管理和持續(xù)性改進(jìn)?Providingframeworkforuser/supplierco-operation為用戶/供應(yīng)商協(xié)作提供框架?Assistingsupplierstoproducerequireddocs協(xié)助供應(yīng)商生產(chǎn)要求文檔?Promotionofcommonlifecycle,language,andterminology建立常用生命周期，語言和術(shù)語?Providingpracticalguidesandexamples提供實(shí)用的指南和例子Business

Benefit

益處23?RiskManagement風(fēng)險(xiǎn)管理?Change&ConfigurationManagement

變更和組態(tài)管理?DesignReview設(shè)計(jì)審核?Traceability追溯性?DocumentManagement文檔管理SupportingProcesses支持過程24Computerised

System

Life

Cycle25計(jì)算機(jī)系統(tǒng)生命周期26ProjectStages27項(xiàng)目階段28?IdentifyCompliancestandardsbasedoncompanyprocedure基于公司流程辨識出一致性標(biāo)準(zhǔn)?GxPAssessmentGxP評估?IdentifyKeyIndividuals:ProcessOwner,SystemOwner,QualityUnit,SME,Supplier,EndUser標(biāo)識關(guān)鍵人?ProduceUserrequirementSpecification書寫URS?DetermineStrategyforAchievingcompliance:RiskAssessment,AssessmentofSystemcomponent,Supplierassessment決定達(dá)成一致的策略：風(fēng)險(xiǎn)評估，系統(tǒng)組件評估，供應(yīng)商評估?Plan計(jì)劃?ReviewandApproveSpecifications審核和批準(zhǔn)規(guī)范?Developteststrategy開發(fā)測試策略?Test測試?Report&release報(bào)告和發(fā)布?MaintainsystemcomplianceduringOpeartion運(yùn)行時(shí)系統(tǒng)一致性維護(hù)?Retirement退役

Regulated

Company

Activities公司活動29?EstablishQMS:Documentedsetofprocedures&standards建立質(zhì)量管理系統(tǒng)：一組流程和標(biāo)準(zhǔn)文檔?EstablishRequirement(whatenduserwants)

建立需求(最終用戶需要什么)?Qualityplanning質(zhì)量計(jì)劃?Assessmentofsub-supplier分包商評估?Producespecifications書寫規(guī)范?Performdesignreview執(zhí)行設(shè)計(jì)審核?Hardware&Softwareproduction/configuration軟硬件生產(chǎn)及組態(tài)?Performtesting執(zhí)行測試?Commercialreleaseofthesystem系統(tǒng)發(fā)布?Provideuserrequirementandtraining提供用戶需求和培訓(xùn)?Supportandmaintainthesysteminoperation運(yùn)行中，支持和維護(hù)系統(tǒng)?SystemRetirementandreplacement系統(tǒng)退役和取代Supplier

activities供應(yīng)商活動30V-model驗(yàn)證生命周期和文件架構(gòu)IF

IT’S

NOT

DOCUMENTED

IT’S

A

RUMOUR!如果沒有被記錄下來，一切都是流言！31計(jì)算機(jī)系統(tǒng)的驗(yàn)證實(shí)施

用戶需求說明

URS

VP

QPP

RAChangeControl用戶需求說明屬于客戶方文件。文件中列出了客戶在本項(xiàng)目系統(tǒng)方面的所有要求。它是編寫功能說明（FS）的基礎(chǔ)驗(yàn)證計(jì)劃驗(yàn)證計(jì)劃是一份描述了整個項(xiàng)目的總體驗(yàn)證策略的文件并列出了客戶的監(jiān)管和質(zhì)量要求。質(zhì)量和項(xiàng)目計(jì)劃質(zhì)量和項(xiàng)目計(jì)劃界定了奧星為滿足客戶的需求在執(zhí)行項(xiàng)目過程中所采取的質(zhì)量措施。另外它還列出了項(xiàng)目的結(jié)果和項(xiàng)目計(jì)劃工作。風(fēng)險(xiǎn)評估項(xiàng)目范圍內(nèi)將包括一個風(fēng)險(xiǎn)評估的過程。此風(fēng)險(xiǎn)評估過程界定出了用于控制對GMP要求或客戶業(yè)務(wù)有影響的風(fēng)險(xiǎn)的必要措施。必須確定出這些風(fēng)險(xiǎn)并對其進(jìn)行評估、文件記錄。最后，必須界定出降低這些風(fēng)險(xiǎn)所必須執(zhí)行的措施并對其進(jìn)行追蹤。變更控制所有能夠影響已經(jīng)批準(zhǔn)的文件的系統(tǒng)變更均需根據(jù)變更控制規(guī)程來進(jìn)行控制。為了保證可以證明所有這些變更均符合計(jì)劃、經(jīng)過評估、批準(zhǔn)、并根據(jù)符合GMP的形式得以實(shí)施并通過文件方式進(jìn)行了記錄，將編寫一份項(xiàng)目SOP來界定控制變更時(shí)所需進(jìn)行的工作。

32計(jì)算機(jī)系統(tǒng)的驗(yàn)證實(shí)施

功能說明

功能說明（FS）中描述了如何來實(shí)現(xiàn)用戶需求說明（URS）中所述的要求和目標(biāo)。本文件

FS

DS

QPDeviation

Manage

ment明確說明了預(yù)期系統(tǒng)的實(shí)現(xiàn)方式。FS由項(xiàng)目執(zhí)行方編寫，由客戶進(jìn)行審查是否有與URS中所述要求有沖突之處及是否確實(shí)能夠?qū)崿F(xiàn)此類要求。FS必須由客戶來批準(zhǔn)。經(jīng)過批準(zhǔn)之后，F(xiàn)S即作為客戶和項(xiàng)目執(zhí)行方在實(shí)現(xiàn)及管理本項(xiàng)目方面具有約束力的協(xié)議。設(shè)計(jì)說明設(shè)計(jì)說明以更為詳細(xì)的方式說明了應(yīng)該如何來在系統(tǒng)中實(shí)現(xiàn)各種功能。其中既涉及到硬件說明又涉及到軟件說明。確認(rèn)計(jì)劃從監(jiān)管的角度來看以及為了控制風(fēng)險(xiǎn)，必須針對相關(guān)的要求進(jìn)行測試。整套測試在不同的測試階段進(jìn)行計(jì)劃、實(shí)施和報(bào)告，各階段在本QPP中做出了說明。在確認(rèn)計(jì)劃中規(guī)定出了這些測試工作的適宜步驟。確認(rèn)計(jì)劃必須考慮客戶對一般情況及確認(rèn)工作的要求，尤其是在URS及驗(yàn)證計(jì)劃中所規(guī)定的要求。此外，風(fēng)險(xiǎn)評估對測試問題的范圍及測試方面均具有一定的影響。偏差管理此規(guī)程保證所有偏差均必須進(jìn)行記錄和控制，直至它們得以糾正。在確認(rèn)計(jì)劃中對此規(guī)程進(jìn)行了描述。

33計(jì)算機(jī)系統(tǒng)的驗(yàn)證實(shí)施

工廠驗(yàn)收測試

工廠驗(yàn)收測試在系統(tǒng)實(shí)施完成之后在系統(tǒng)供應(yīng)商的場地進(jìn)行。工廠驗(yàn)收測試完成之后客戶

FAT

SAT-IQSAT-OQ

IQ應(yīng)同意系統(tǒng)發(fā)貨。進(jìn)行詳盡的工廠驗(yàn)收測試的另一個優(yōu)點(diǎn)在于能夠盡早地檢測到軟件編程中所存在的錯誤，以在客戶現(xiàn)場安裝系統(tǒng)之前將其糾正。客戶應(yīng)到場檢查/見證工廠驗(yàn)收測試的執(zhí)行?，F(xiàn)場驗(yàn)收測試-安裝確認(rèn)現(xiàn)場驗(yàn)收測試是為了證明系統(tǒng)根據(jù)規(guī)定進(jìn)行了安裝、能夠在其運(yùn)行環(huán)境下正常工作、且與儀表及設(shè)備的界面符合規(guī)定。因?yàn)楝F(xiàn)場驗(yàn)收測試的重點(diǎn)在于安裝及功能方面，所以進(jìn)一步被劃分為SAT-IQ和SAT-OQ。SAT-IQ是為了證明系統(tǒng)被正確地在客戶的目標(biāo)環(huán)境中進(jìn)行了安裝。現(xiàn)場驗(yàn)收測試-運(yùn)行確認(rèn)SAT-OQ屬于現(xiàn)場驗(yàn)收測試的一部分，它是為了證明系統(tǒng)能夠在其運(yùn)行環(huán)境下正常運(yùn)行，且其與儀表和設(shè)備的界面符合規(guī)定。安裝確認(rèn)與SAT-IQ相比，IQ應(yīng)由客戶來負(fù)責(zé)進(jìn)行。必須要證明系統(tǒng)根據(jù)技術(shù)說明進(jìn)行了正確的安裝（硬件和軟件）。除了SAT-IQ中已經(jīng)進(jìn)行的測試之外，IQ中需要包括一些由客戶所增加的測試。

34計(jì)算機(jī)系統(tǒng)的驗(yàn)證實(shí)施

運(yùn)行確認(rèn)OQQRVRTM與SAT-OQ相比，OQ應(yīng)由客戶來負(fù)責(zé)進(jìn)行。必須要證明系統(tǒng)具有符合技術(shù)說明的正確功能。除了SAT-OQ中已經(jīng)進(jìn)行的測試之外，OQ中需要包括一些由客戶所增加的，在盡可能接近生產(chǎn)工藝環(huán)境條件下進(jìn)行的功能測試。確認(rèn)報(bào)告確認(rèn)報(bào)告匯總出了各單一測試階段的結(jié)果，并報(bào)告所出現(xiàn)的重大或輕微偏差是否已經(jīng)清除。本報(bào)告中包括所有測試階段是否充分完成以及系統(tǒng)是否得以確認(rèn)的結(jié)論。驗(yàn)證報(bào)告驗(yàn)證報(bào)告匯總出了單一項(xiàng)目階段的整個結(jié)果，并說明了整體最終驗(yàn)證結(jié)果。此文件必須以客戶為責(zé)任方進(jìn)行編寫。可追溯矩陣根據(jù)GAMP5，應(yīng)建立以文件形式記錄要求與說明和設(shè)計(jì)成分之間的可追溯性、以及這些成分與相應(yīng)測試之間的可追溯性的流程。所有要求都必須在說明文件及測試中得以考慮，不能有任何遺漏項(xiàng)。可追溯性矩陣可幫助項(xiàng)目團(tuán)隊(duì)在整個項(xiàng)目過程中審查所有與要求相關(guān)的項(xiàng)目。它可以在項(xiàng)目生命周期中雙向檢查并追蹤要求的處理情況。

35Anyquestion?36GAMP5Software

&

Hardware

Categories軟件和硬件類別37GAMP5HardwareCategories硬件類別38GAMP5SoftwareCategories軟件類別39Softwarethe

GAMP5SoftwareCategories軟件類別Category類別4,configured可配置Description說明Software,oftenverycomplex,thatcanbeconfiguredbytheusertomeetthespecificneedsoftheuser’sbusinessprocess.Softwarecodeisnotaltered這種軟件通常非常復(fù)雜，可以由用戶來進(jìn)行配置以滿足用戶具體業(yè)務(wù)流程的特殊要求。這種軟件的編碼不能更改。Typicalexamples典型示例?DAQsystems?SCADA?DCS?BMS?HMI?LIMS?ERP?ClinicaltrailmonitoringTypicalApproach典型方法?Lifecycleapproach生命周期法?Riskbasedapproachtosupplierassessment基于風(fēng)險(xiǎn)的供應(yīng)商評估法?SupplierQMS供應(yīng)商的質(zhì)量管理系統(tǒng)?Recordversionnumber,verifycorrectinstallation記錄版本號，驗(yàn)證正確的安裝方式?Riskbasedtestinginatestenvironment在測試環(huán)境中根據(jù)風(fēng)險(xiǎn)進(jìn)行測試?Riskbasedtestingwithinthebusinessprocess在業(yè)務(wù)流程中根據(jù)風(fēng)險(xiǎn)進(jìn)行測試?Procedureinplaceformaintainingcompliance具有維持符合性的規(guī)程5,Custom定制?Internally,customexternallydevelopeddesignedandITapplications.內(nèi)部codedtosuit和外部開發(fā)的IT應(yīng)用程

business序processSameascat4plus與第4類相同，再加上?Morerigoroussupplierassessment,withpossiblesupplieraudit更嚴(yán)格的公用設(shè)施評估，包括可能進(jìn)行供應(yīng)商審計(jì)?Possessionoffulllifecycle完整的生命周40SoftwareCategory3第3類軟件41SoftwareCategory4第4類軟件42SoftwareCategory5第5類軟件43GAMP5

Planning

Phase

計(jì)劃階段URS用戶需求說明44User

Requirement

Specification用戶需求說明???????Mostimportantdocument最重要的文件Describeswhatthesystemissupposedtodo描述系統(tǒng)預(yù)期用途NormallywrittenbytheSupplier通常由供應(yīng)商編寫ControlledDocument受控文件ForCat3writtenforaspecificsolution第3類針對具體解決方案編寫ForCat4&5Itiswritteningeneral第4、5類整體編寫Sufficient,Realistic,Measurable,Achievable充分、現(xiàn)實(shí)、可衡量、可

達(dá)到?Testable:Clear,Precise,basisforformaltesting可測量：清楚、簡潔、

正式測試的基礎(chǔ)?Traceable:Designandtesting可追溯：設(shè)計(jì)和測試?Definepriority:Mandatory,Beneficial,Nicetohave規(guī)定優(yōu)先級：必須、

有益、有了更好

45URS-Content用戶需求說明-內(nèi)容?Introduction:介紹–Whoproducedthedocument文件編寫人–Contractualstatus合同狀態(tài)

–Relationshiptootherdocument與其它文件關(guān)系?Overview:Backgroundtotheproject概述：項(xiàng)目背景?Scope:范圍–Systemboundaries系統(tǒng)范圍–Keyobjectiveandbenefits關(guān)鍵目標(biāo)和益處–ApplicableGXPrequirement適用GXP要求–Otherapplicableregulations其它適用法規(guī)46URS-Content:

Operational

RequirementURS-內(nèi)容：操作要求?Functions功能–Whatisthesystemrequiretodo系統(tǒng)要求的功能–Calculations計(jì)算–Modesofoperation(UseCases)操作模式（使用示例）–Alarms報(bào)警–FailureModes故障模式–Safety安全–ElectronicsRecords,AuditTrail,&Electronics

Signature電子記錄、審計(jì)跟蹤、電子簽名–Reports,datafiles,etc報(bào)告、數(shù)據(jù)文件等47URS-Content:

Operational

RequirementURS-內(nèi)容：操作要求?Data數(shù)據(jù)–Datahandlingrequirement(Paper,Electronics)數(shù)據(jù)處理要求（物理版、電

子版）–Dataimpact數(shù)據(jù)影響–Definitionofdata:format,criticalparameters,datarangelimits,required

accuracy,etc數(shù)據(jù)的定義：格式、關(guān)鍵參數(shù)、數(shù)據(jù)范圍、所要求準(zhǔn)確性等–ElectronicsRecords,AuditTrail,&ElectronicsSignature電子記錄、審計(jì)跟

蹤、電子簽名–Reports,datafiles,etc報(bào)告、數(shù)據(jù)文件等–Datamigration數(shù)據(jù)遷移–Datainputandsubsequentediting數(shù)據(jù)輸入及之后的編輯–Backup&recovery備份和恢復(fù)–Archiverequirement存檔要求–DataSecurityandintegrity數(shù)據(jù)安全和完整性

48URS-Content:

Operational

RequirementURS-內(nèi)容：操作要求?Technicalrequirement技術(shù)要求–Startup,shutdown,Coldstart,Warmstart,Hotstart啟動、停機(jī)、冷起、暖起、熱起–Disasterrecovery災(zāi)難恢復(fù)–Performanceandtimingrequirement性能和計(jì)時(shí)要求–ActiononComponentfailure對部件故障的措施–Hardwarerequirement硬件要求–Portability便攜性–Efficiency效率–Configurability可配置性49

URS-Content:

Operational

Requirement

URS-內(nèi)容：操作要求?Interfaces界面

–I/Olisting

–I/O列表

–Interfacetoothersystems/equipment

–與其它系統(tǒng)/設(shè)備界面

–HMI

–Usersgroupsandtheiraccessrights

–用戶組及其訪問權(quán)限

–Networkprotocolssupported:serial,OPC,Profibus

–所支持網(wǎng)絡(luò)協(xié)議：序列、OPC、Profibus?Environment環(huán)境?Physicalcondition:Temp,Humidity,Hazardous?物理環(huán)境：溫度、濕度、危害?Physicalspaceandlimitations?物理空間和局限?Utilities公用工程

50URS-ContentURS-內(nèi)容：?Constraints限制條件–Availability(redundancy?)&reliability–可用性（冗余？）和可靠性–Expansioncapability–擴(kuò)展容量–Futureexpansion–未來擴(kuò)展–Expectedlifetime–預(yù)期使用壽命–Longtermsupport–長期支持51

URS-Content

URS-內(nèi)容：?LifeCyclerequirement生命周期要求

–Developmentrequirement:GAMP5

–開發(fā)要求：GAMP5

–SupplierQualityrequirement

–供應(yīng)商質(zhì)量要求

–Documentationrequirement––––文件要求TestingRequirement:Internaltesting,FAT,SAT測試要求：內(nèi)部測試、FAT、SATTraining–培訓(xùn)–Supportandmaintenanceservice–支持和維護(hù)服務(wù)–Spares–備件

52Anyquestion?53GAMP5

Planning

PhaseGAMP5計(jì)劃階段Quality

and

Project

Plan質(zhì)量及項(xiàng)目計(jì)劃54Quality

Plan質(zhì)量計(jì)劃?AQualityPlanisakeydocumentindefiningtheprojectlifecycle.Itsetsout

theproposedmethodofmeetingtheuserqualityrequirementsandallows

agreementofthecontrollingproceduresforeachprojectactivity.?質(zhì)量計(jì)劃是一個關(guān)鍵文件，它界定了項(xiàng)目的生命周期。規(guī)定出了為了滿足用戶質(zhì)量要求所提議采取的方法，使各項(xiàng)項(xiàng)目工作符合控制規(guī)程的要求。?QualityPlanistheresponsibilityofthesupplier?質(zhì)量計(jì)劃屬于供應(yīng)商的責(zé)任?Itshouldnormallybesuppliedwithinthefirstweekofsigningcontract.?一般需在簽訂合同之后一周內(nèi)提供?ItiswritteninresponsetoValidationPlan?應(yīng)作為對驗(yàn)證計(jì)劃的響應(yīng)而編寫?ItneedstobeapprovedbyUser.?需要由用戶來批準(zhǔn)?Generallyonceapprovedshouldnotrequirefurtherrevision.?一般批準(zhǔn)之后不需再進(jìn)行修訂55QP-

Contents

QP-內(nèi)容?RelationshiptootherDocuments與其它文件關(guān)系–Applicablestandard適用標(biāo)準(zhǔn)–RelationshiptocustomerValidationRequirements與客戶驗(yàn)證要求之間關(guān)系–Non-ConformancewithUserRequirement與用戶需求的不符合項(xiàng)–Relationshipt?Projectoverview項(xiàng)目概述–SummaryofProcesstobecontrolled所需控制工藝概述–RelevantGxPregulations相關(guān)GxP法規(guī)–ImpactonPatientSafety,ProductQuality,dataintegrity對患者安全、產(chǎn)品質(zhì)量和數(shù)據(jù)完整性的影響–Projectboundariesandinterfaces(scopeofsupplyandvalidation項(xiàng)目范圍和接口（供貨范圍和驗(yàn)證）–SystemArchitecture系統(tǒng)結(jié)構(gòu)–Systemclassification:Hardwareandsoftwarecategories系統(tǒng)分類：硬件和軟件類別56QP-Contents

QP-內(nèi)容?ProjectLifeCyclephases項(xiàng)目生命周期階

段–ItshouldfollowGAMP5LifeCycle

model應(yīng)遵循GAMP5所規(guī)定生命周期

模型–Listwhatactivitieswillbeperformed

列出所需進(jìn)行工作–Defineswhowillberesponsiblefor

executingeachactivity確定執(zhí)行每項(xiàng)

工作的負(fù)責(zé)人–Thelevelofactivitydependsonthe

degreeofnovelty工作的內(nèi)容取決于

新穎性程度–Dependingonthesizeand

complexity,somedocumentsmaybe

mergedintoasingleone根據(jù)規(guī)模和

復(fù)雜性，有些文件可以合為一個文件–Documentscreatedneedtobereviewedandapprovedbyenduser所編寫文件需要由最終用戶審核批準(zhǔn)

計(jì)劃

技術(shù)說明

報(bào)告檢查確認(rèn)配置和編碼包括風(fēng)險(xiǎn)管理在內(nèi)的支持性流程57QP-Contents

–

Project

Life

CycleQP-內(nèi)容-項(xiàng)目生命周期?PlanningPhase計(jì)劃階段–ReviewofURS–審核URS–CreationofProjectscheduleandapproval–編制并批準(zhǔn)項(xiàng)目進(jìn)度時(shí)間表–CreationofQualityPlanandapproval–編寫和批準(zhǔn)質(zhì)量計(jì)劃58QP-Contents

–

Project

Life

CycleQP-內(nèi)容-項(xiàng)目生命周期?SpecificationPhase技術(shù)說明階段–CreationofFunctionalDesignandApproval–編寫并批準(zhǔn)功能設(shè)計(jì)說明–CreationofHardwareDesignincludingDrawingsandapproval–編寫并批準(zhǔn)硬件設(shè)計(jì)說明，包括圖紙–RiskAssessment–風(fēng)險(xiǎn)評估–CreationofSoftwareDesignandapproval–編寫并批準(zhǔn)軟件設(shè)計(jì)說明–CreationofSoftwareModuledesignandapproval–編寫并批準(zhǔn)軟件模塊設(shè)計(jì)說明59Scalability

of

Activities工作的可放大性60QP-Contents

–

Project

Life

CycleQP-內(nèi)容-項(xiàng)目生命周期?ConfigurationandCodingPhase配置和編碼階段–OrderHardware–訂購硬件–BuildSystem–構(gòu)建系統(tǒng)–Developsoftware–開發(fā)軟件–ProduceconfigurationscheduleandConfigurationmanagement–制定配置計(jì)劃時(shí)間表和配置管理–Integratethesystem–集成系統(tǒng)61QP-Contents

–

Project

Life

CycleQP-內(nèi)容-項(xiàng)目生命周期?VerificationPhase驗(yàn)證階段–SoftwareCodeReview軟件代碼回顧–CreateSoftwareModuleTestProtocolandapprove–編寫并批準(zhǔn)軟件模塊測試方案–CreateFactoryAcceptanceTestspecProtocolandapprove(hardwareandSoftware)–編寫并批準(zhǔn)工廠驗(yàn)收測試規(guī)程和方案（硬件和軟件）–CreateSiteAcceptanceTestProtocolandapprove–編寫并批準(zhǔn)現(xiàn)場驗(yàn)收測試方案–ExecuteInternalSoftwareModuleTestandreviewresult–執(zhí)行內(nèi)部軟件模塊測試并審查結(jié)果–ExecuteInternalFATtestandreviewresult–執(zhí)行內(nèi)部FAT測試并審查結(jié)果–ExecutewitnessedFATtestandreviewresult–執(zhí)行并見證FAT測試并審查結(jié)果–Shiptosite運(yùn)至現(xiàn)場–Installandcommission安裝調(diào)試–ExecuteSiteAcceptanceTestandReviewresult–執(zhí)行現(xiàn)場驗(yàn)收測試并審查結(jié)果62QP-Contents

–

Project

Life

CycleQP-內(nèi)容-項(xiàng)目生命周期?ReportingPhase報(bào)告階段–Generatesystemfinaldocumentation,review&approve–生成系統(tǒng)最終文件并進(jìn)行審批–Ensureallthedesigndocumentsare“asBuilt”version–保證所有設(shè)計(jì)文件均為“竣工”版本–Createtechnicalmanual編寫技術(shù)手冊–ProvideTrainingforOperators,engineers,etc–為操作人員、工程師等進(jìn)行培訓(xùn)–GenerateFinalQualityreportandHandoverchecklist,reviewandapprove–生成最終質(zhì)量報(bào)告和移交檢查表并進(jìn)行審查–Completehandover完成移交63QP-ContentsQP-內(nèi)容?SupportingActivities支持性工作–Traceability可追溯性–ChangeManagement變更管理–ConfigurationManagement配置管理?Itemstobecontrolled所需控制項(xiàng)目?Versioncontrol版本控制–DocumentationManagement文件管理?Versioncontrol版本控制?Documentstobeprovidedandformat所需提供文件及其格式64–項(xiàng)目進(jìn)程報(bào)告–ProjectMilestones–項(xiàng)目里程碑

QP-Contents

QP-內(nèi)容?ProjectPlanning項(xiàng)目計(jì)劃

–Projectteamanditsorganisation

–項(xiàng)目團(tuán)隊(duì)及其組織

–Projectprogressreporting

Glory

He

Project

Manager

(PM)

(nominated

primary

contact)

(responsible

for

validation)

Matt

Safi

Validation

consultant

Hardware

Engineers

Ivan

Gao

Alice

Lv

Software

Engineer(s)

Alice

Lv

Elaine

Wang

Quality

Manager

(QM)

Quality

Assurance

(QA)

Glory

He

Lead

Engineer

(LE)

Drawing

Office

(DO)

Ivan

Gao

65Anyquestion?66GAMP5

Planning

PhaseRisk

AssessmentGAMP5計(jì)劃階段風(fēng)險(xiǎn)評估67Risk

Assessment風(fēng)險(xiǎn)評估?IdentifyCritical

Quality

Attributes

(CQAs)forproductduringdrugdevelopment.These

areattributeslikepurity,potency,stabilitywhichareintrinsictotheproduct.在產(chǎn)品開發(fā)過

程中確定關(guān)鍵質(zhì)量屬性（CQA）。例如對產(chǎn)品而言非常重要的純度、效價(jià)、穩(wěn)定性。?ClassifytheseCQAsintermsoftheireffectonpatientsafety根據(jù)關(guān)鍵質(zhì)量屬性對患者安全性的影響對其分類。?IdentifymaterialattributesandprocessparameterswhichmightaffectanyoftheCQAs

(egpuritymightbeaffectedby:purityoftheinputmaterials;temperatureofprocessing;cleanlinessofequipment…).確定可能會影響任何關(guān)鍵質(zhì)量屬性（例如純度可能會受輸入原料的純度、工藝溫度、設(shè)備潔凈度等影響）的材料屬性和工藝參數(shù)?IdentifytheDesign

Spaceforthosematerialattributesandprocessparameters(ie

determinehowtheycanvarywhilststillgivinggoodqualityproduct)inordertodetermine

whichareCriticalMaterialAttributesorCritical

Process

Parameters

(CPPs)andtogiveeachanimpactrating確定這些物料屬性和工藝參數(shù)的設(shè)計(jì)空間（即確定在保證良好產(chǎn)品質(zhì)量的同時(shí)其所允許的變化范圍）以確定哪些是關(guān)鍵質(zhì)量屬性或關(guān)鍵工藝參數(shù)并對其進(jìn)行影響性評定?Usethatinformationtoproposeacontrol

strategyfortheprocesswhichwillguarantee

operationwithinthedesignspaceandalsoguaranteethatanynecessarydatatoprovethisiscollected.使用該信息為將保證操作在設(shè)計(jì)空間范圍內(nèi)并保證收集了證明這一點(diǎn)的數(shù)據(jù)的流程而提出的控制策略?CreateaURSwhichsplitsthecontrolstrategyintoindividualfunctions(relatedtocritical

processparameters)andclassifiedaccordingtotheirimpactonproductquality/patientsafety/dataintegrity.編制URS將該控制策略分為各單獨(dú)的功能（與關(guān)鍵工藝參數(shù)相關(guān)）并根據(jù)其對產(chǎn)品質(zhì)量/患者安全性/數(shù)據(jù)完整性的影響將其分類。68Risk

Assessment風(fēng)險(xiǎn)評估?RiskAssessmentreportdetailstheriskassessmentandmitigationprocessthroughouttheprojectlifecycle.

風(fēng)險(xiǎn)評估報(bào)告詳細(xì)描述了整個項(xiàng)目周期中風(fēng)險(xiǎn)評定和?RiskAssessmentistheresponsibilityoftheuser,supportedbysupplier風(fēng)險(xiǎn)評估是用戶的責(zé)任，受供應(yīng)商的支持?RiskAssessmentisacontinuousprocessandmust

becarriedoutatvariousstagesduringsystemlife

cycle風(fēng)險(xiǎn)評估是一個連續(xù)的過程，在系統(tǒng)生命周期的不同階段都要執(zhí)行69RA-

Contents風(fēng)險(xiǎn)評估-內(nèi)容?RelationshiptootherDocuments與其它文件的關(guān)系–Applicablestandard適用標(biāo)準(zhǔn)–RelationshiptocustomerUserRequirementsSpecification與客戶用戶需求說明之間關(guān)系?Projectoverview項(xiàng)目概述–SummaryofProcesstobecontrolled所需控制工藝概述–RelevantGxPregulations相關(guān)GxP法規(guī)–Projectboundariesandinterfaces(scopeofsupplyandvalidation項(xiàng)目范圍和界面（供貨范圍和驗(yàn)證）–SystemArchitecture系統(tǒng)結(jié)構(gòu)–Systemclassification:Hardwareandsoftwarecategories系統(tǒng)分類：硬件和軟件類別70?Probability

of

a

failure??????故障可能性？Delectability

of

a

failure?故障可檢測性？How

risk

managed?風(fēng)險(xiǎn)如何控制進(jìn)行功能性風(fēng)險(xiǎn)評估并確定控制模式

實(shí)施并確認(rèn)適宜控制

審查風(fēng)險(xiǎn)并監(jiān)控控制

Quality

Risk

Assessment質(zhì)量風(fēng)險(xiǎn)評估

?IsitGxP?是否屬于GxP

?Whathazards?有什么危害？

?Impactlevel?影響級別？

進(jìn)行最初風(fēng)險(xiǎn)評估并確定系統(tǒng)影響

確定對患者安全、產(chǎn)品質(zhì)量和數(shù)據(jù)完整性有影響的功能71GxP

Assessment

GxP評估7172System

Impact

Classification系統(tǒng)影響性分類7273SystemClassification系統(tǒng)分類7374Risk

assessment

method風(fēng)險(xiǎn)評估方法75Identification

of

Controls確定控制?Theoutputoftheriskassessmentprocess(riskpriority)isusedto

decideuponappropriatecontrols.