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

Austar

Promotes

Industry

AdvancementGAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí)魯抗立科公司自控驗(yàn)證探討當(dāng)前1頁(yè)，總共147頁(yè)。.hkGAMP5(GoodAutomated

Manufacturing

Practice)良好自動(dòng)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)管理方法當(dāng)前2頁(yè)，總共147頁(yè)。Different

Terminology不同的術(shù)語(yǔ)?????ComputerisedSystems計(jì)算機(jī)系統(tǒng)Automation

Systems自動(dòng)化系統(tǒng)Control

Systems控制系統(tǒng)ControlEquipment控制設(shè)備DataManagement

systems數(shù)據(jù)管理系統(tǒng)ComputerisedSystem:

Asystem

including

theinputof

data,electronicprocessing

andthe

output

ofinformationtobe

usedeither

for

reporting

orautomaticcontrol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(jiàn)稿）

.hk當(dāng)前3頁(yè)，總共147頁(yè)。

Introduce

簡(jiǎn)介GAMP5（Good

Automated

Manufacturing

Practice-Rev5）GAMP是由國(guó)際制藥工程協(xié)會(huì)（ISPE）主編的實(shí)踐指南。自90年代以來(lái)，不斷改版的良好自動(dòng)化生產(chǎn)實(shí)踐指南被廣泛使用并得到國(guó)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).hk當(dāng)前4頁(yè)，總共147頁(yè)。FDA(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(guó)藥管局和其它歐盟國(guó)家的對(duì)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(huì)

.hk

-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(guó)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(guó)的FDA)

Industry

Regulators行業(yè)監(jiān)管機(jī)構(gòu)-

Regulate

to

ensure

safetyofdrugsthat

any

of

us

mighttake!-通過(guò)管理保證我們?nèi)魏稳硕伎赡苡玫降乃幤返陌踩?Allhave

thepower

to

refuseimportsif

theirregulationsare

notmet.當(dāng)前5頁(yè)，總共147頁(yè)。.hkUS

FDA?

Automated

processes.

Whencomputers

or

automated

data

processing

systemsareused

as

part

ofproduction

orthe

qualitysystem,

the

manufacturershall

validate

computer

softwarefor

its

intendeduseaccordingto

an

established

protocol.

All

software

changesshall

bevalidated

before

approval

andissuance.

Thesevalidationactivities

and

results

shall

be

documented.

自動(dòng)化過(guò)程。當(dāng)計(jì)算機(jī)或自動(dòng)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(dòng)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部分當(dāng)前6頁(yè)，總共147頁(yè)。.hkEMEA?

Validation:Theextent

ofvalidation

necessary

will

depend

on

a

numberof

factors

includingtheuse

towhich

the

system

is

to

be

put,

whether

the

validation

isto

be

prospective

orretrospectiveand

whether

or

not

novel

elementsare

incorporated.Validation

shouldbe

consideredas

partofthe

complete

life

cycle

of

a

computer

system.

Thiscycle

includesthe

stages

of

planning,

specification,programming,

testing,commissioning,documentation,operation,monitoringand

modifying.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(wú)論驗(yàn)證是預(yù)見(jiàn)性的還是回顧性的，無(wú)論有無(wú)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(gè)周期包括設(shè)計(jì)，規(guī)范，編程，測(cè)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)當(dāng)前7頁(yè)，總共147頁(yè)。.hkSFDA?Where

automatedandmonitoringsystems

areused

for

these

applicationsthey

should

be

validatedtoensurethat

critical

process

requirements

are

met.使用自動(dòng)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(guò)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(jiàn)稿）第12章最終滅菌當(dāng)前8頁(yè)，總共147頁(yè)。Addition補(bǔ)充

第110條（第1次的是115條款）：使用計(jì)算機(jī)化倉(cāng)儲(chǔ)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(cuò)。

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(guò)核對(duì)。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(guò)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(lái)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(lái)源：sFDA藥品生產(chǎn)質(zhì)量管理規(guī)范送審版第2次

.hk2009.12.10當(dāng)前9頁(yè)，總共147頁(yè)。.hkPurpose

目的?

Cost

effectiveframeworkof

good

practice

to

ensurethat

computerisedsystems

are

fit

forthe

intended

use

and

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:Patient

safety,products

quality,&dataintegrity保證條款：患者安全，產(chǎn)品質(zhì)量和數(shù)據(jù)完整?

Provide

suppliersguidanceon

thedevelopment

and

maintenanceof

the

systems

by

following

goodpractice.

通過(guò)良好實(shí)踐，為供應(yīng)商提供系統(tǒng)開(kāi)發(fā)和維護(hù)的指導(dǎo)當(dāng)前10頁(yè)，總共147頁(yè)。.hkKey

Concepts當(dāng)前11頁(yè)，總共147頁(yè)。.hk關(guān)鍵概念當(dāng)前12頁(yè)，總共147頁(yè)。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(kāi)發(fā)過(guò)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(duì)患者安全的影響對(duì)關(guān)鍵質(zhì)量屬性進(jìn)行分類

Impact

on

Patient

Safety?對(duì)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

.hkGAMP5

KEY

CONCEPTS

1-

product/Process

Understanding

GAMP5關(guān)鍵概念-對(duì)產(chǎn)品/工藝的理解

‐

fundamental

to

determining

system

requirements.

對(duì)決定系統(tǒng)要當(dāng)前13頁(yè)，總共147頁(yè)。End

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(duì)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？

.hkGAMP5

KEY

CONCEPTS

1-

product/Process

Understanding

GAMP5關(guān)鍵概念-對(duì)產(chǎn)品/工藝的理解當(dāng)前14頁(yè)，總共147頁(yè)。.hkEnd

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(guò)這種信息來(lái)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(duì)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(xiě)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）。當(dāng)前15頁(yè)，總共147頁(yè)。.hkPlanningcover:計(jì)劃包含activities,

Responsibility,procedures

&time

lines活動(dòng)，責(zé)任，流程和時(shí)間表Specification:規(guī)范enablesystem

tobedeveloped,verified

&Maintained.

Itmaybesuppliedbya

supplier使系統(tǒng)可以被開(kāi)發(fā)，驗(yàn)證和維護(hù).可由供應(yīng)商提供Verification驗(yàn)證Normalcase

(+ve

testing),Invalidcase

(-ve

testing),

Repeatability,Performance,Volume/load,Regression,Structural

testing常規(guī)，非法，重復(fù)，性能，負(fù)載，不變，結(jié)構(gòu)性測(cè)試Validationreport:

驗(yàn)證報(bào)告Summerising

activitiesperformed,deviations,outstanding

andcorrectiveactions總結(jié)執(zhí)行的活動(dòng)，偏差，超標(biāo)和動(dòng)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)的生命周期法當(dāng)前16頁(yè)，總共147頁(yè)。Tablet

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

.hk214

(indirect

impact

only)僅

間接影響5

(no

impact)無(wú)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(duì)生命周

期活動(dòng)進(jìn)行評(píng)價(jià)：a)

system

impact

on

patient

safety,

product

quality

and

data

integrity

系

統(tǒng)對(duì)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(duì)如下控制系統(tǒng)進(jìn)行排序：當(dāng)前17頁(yè)，總共147頁(yè)。?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

.hk

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(dòng)

Life

cycle

activities

should

be

scaled

according

to:應(yīng)從如下方面對(duì)生命周期

活動(dòng)進(jìn)行評(píng)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(duì)如下軟件模塊進(jìn)行排序：當(dāng)前18頁(yè)，總共147頁(yè)?！癆pplication

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(duì)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.hkGAMP5

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)管理當(dāng)前19頁(yè)，總共147頁(yè)。“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(píng)估之后，符合監(jiān)管要求的公司應(yīng)在系統(tǒng)的整個(gè)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(shí)、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(shí)：

工藝控制專有技術(shù)Experience:

validating

control

systems

to

GAMP經(jīng)驗(yàn)：

根據(jù)GAMP對(duì)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.hk當(dāng)前20頁(yè)，總共147頁(yè)。.hk?Process

Owner:

The

person

ultimately

responsible

for

the

businessprocess

or

processes

being

managed過(guò)程所有者：為最終生產(chǎn)或被管理的過(guò)程而負(fù)責(zé)的人?

System

Owner:

The

person

ultimately

responsible

for

the

availability

,

support,

and

maintenance

of

a

system

and

for

the

security

of

the

data

residing

on

that

system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:

Those

individuals

with

specific

expertise

in

aparticular

area

or

field.

SME

should

take

the

lead

role

in

theverification

of

computerised

systems.

SME

responsibilities

includeplanning

and

defining

verification

strategies,

defining

acceptancecriteria,

selection

of

appropriate

test

methods,

execution

ofverification

tests

and

reviewing

results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(cè)試方法，執(zhí)行驗(yàn)證測(cè)試和審核結(jié)果Key

Personnel關(guān)鍵人當(dāng)前21頁(yè)，總共147頁(yè)。.hkBenefits

to

both

regulated

companies

&

supplier:公司和供應(yīng)商均得到的益處?Reduction

of

cost

&

time

takento

achieve

and

maintain

compliance降低實(shí)現(xiàn)和維護(hù)一致性的費(fèi)用和時(shí)間?

Early

defectidentification

and

resolution:

reduce

cost,speed

早期的辨識(shí)和解決：降低費(fèi)用，提高速度?Costeffective

operation

andmaintenance高效運(yùn)行和維護(hù)?

Effective

changemanagement

and

continuous

improvement有效的變更管理和持續(xù)性改進(jìn)?Providingframework

for

user/supplier

co-operation為用戶/供應(yīng)商協(xié)作提供框架?Assistingsuppliersto

producerequireddocs協(xié)助供應(yīng)商生產(chǎn)要求文檔?

Promotion

of

common

lifecycle,

language,

and

terminology建立常用生命周期，語(yǔ)言和術(shù)語(yǔ)?Providingpractical

guides

andexamples提供實(shí)用的指南和例子Business

Benefit

益處當(dāng)前22頁(yè)，總共147頁(yè)。.hk?RiskManagement風(fēng)險(xiǎn)管理?Change&ConfigurationManagement

變更和組態(tài)管理?Design

Review設(shè)計(jì)審核?

Traceability追溯性?

Document

Management文檔管理Supporting

Processes

支持過(guò)程當(dāng)前23頁(yè)，總共147頁(yè)。.hkComputerised

System

Life

Cycle當(dāng)前24頁(yè)，總共147頁(yè)。.hk計(jì)算機(jī)系統(tǒng)生命周期當(dāng)前25頁(yè)，總共147頁(yè)。.hkProject

Stages當(dāng)前26頁(yè)，總共147頁(yè)。.hk項(xiàng)目階段當(dāng)前27頁(yè)，總共147頁(yè)。?

Identify

Compliance

standards

basedon

companyprocedure基于公司流程辨識(shí)出一致性標(biāo)準(zhǔn)?GxP

AssessmentGxP評(píng)估?IdentifyKey

Individuals:

ProcessOwner,

SystemOwner,Quality

Unit,

SME,Supplier,

End

User標(biāo)識(shí)關(guān)鍵人?Produce

UserrequirementSpecification書(shū)寫(xiě)URS?DetermineStrategy

forAchievingcompliance:

RiskAssessment,Assessment

of

Systemcomponent,

Supplierassessment決定達(dá)成一致的策略：風(fēng)險(xiǎn)評(píng)估，系統(tǒng)組件評(píng)估，供應(yīng)商評(píng)估?Plan計(jì)劃?Review

and

Approve

Specifications審核和批準(zhǔn)規(guī)范?Develop

test

strategy開(kāi)發(fā)測(cè)試策略?

Test測(cè)試?Report

&

release報(bào)告和發(fā)布?Maintainsystemcompliance

during

Opeartion運(yùn)行時(shí)系統(tǒng)一致性維護(hù)?

Retirement退役

.hkRegulated

Company

Activities公司活動(dòng)當(dāng)前28頁(yè)，總共147頁(yè)。.hk?Establish

QMS:

Documented

setof

procedures

&

standards建立質(zhì)量管理系統(tǒng)：一組流程和標(biāo)準(zhǔn)文檔?Establish

Requirement

(what

enduserwants)

建立需求(最終用戶需要什么)?Quality

planning質(zhì)量計(jì)劃?

Assessmentofsub-supplier分包商評(píng)估?

Produce

specifications書(shū)寫(xiě)規(guī)范?

Perform

design

review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(cè)試?Commercial

release

of

the

system系統(tǒng)發(fā)布?Provide

userrequirement

and

training提供用戶需求和培訓(xùn)?

Support

andmaintain

thesysteminoperation運(yùn)行中，支持和維護(hù)系統(tǒng)?System

Retirement

and

replacement系統(tǒng)退役和取代Supplier

activities供應(yīng)商活動(dòng)當(dāng)前29頁(yè)，總共147頁(yè)。.hkV-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(méi)有被記錄下來(lái)，一切都是流言！當(dāng)前30頁(yè)，總共147頁(yè)。計(jì)算機(jī)系統(tǒng)的驗(yàn)證實(shí)施

用戶需求說(shuō)明

URS

VP

QPP

RAChangeControl用戶需求說(shuō)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(xiě)功能說(shuō)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(gè)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(guò)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(píng)估項(xiàng)目范圍內(nèi)將包括一個(gè)風(fēng)險(xiǎn)評(píng)估的過(guò)程。此風(fēng)險(xiǎn)評(píng)估過(guò)程界定出了用于控制對(duì)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(duì)其進(jìn)行評(píng)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(duì)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(lái)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(guò)評(píng)估、批準(zhǔn)、并根據(jù)符合GMP的形式得以實(shí)施并通過(guò)文件方式進(jìn)行了記錄，將編寫(xiě)一份項(xiàng)目SOP來(lái)界定控制變更時(shí)所需進(jìn)行的工作。

.hk當(dāng)前31頁(yè)，總共147頁(yè)。計(jì)算機(jī)系統(tǒng)的驗(yàn)證實(shí)施

功能說(shuō)明

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

FS

DS

QPDeviation

Manage

ment明確說(shuō)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(xiě)，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(lái)批準(zhǔn)。經(jīng)過(guò)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(shuō)明設(shè)計(jì)說(shuō)明以更為詳細(xì)的方式說(shuō)明了應(yīng)該如何來(lái)在系統(tǒng)中實(shí)現(xiàn)各種功能。其中既涉及到硬件說(shuō)明又涉及到軟件說(shuō)明。確認(rèn)計(jì)劃從監(jiān)管的角度來(lái)看以及為了控制風(fēng)險(xiǎn)，必須針對(duì)相關(guān)的要求進(jìn)行測(cè)試。整套測(cè)試在不同的測(cè)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(shuō)明。在確認(rèn)計(jì)劃中規(guī)定出了這些測(cè)試工作的適宜步驟。確認(rèn)計(jì)劃必須考慮客戶對(duì)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(píng)估對(duì)測(cè)試問(wèn)題的范圍及測(cè)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(duì)此規(guī)程進(jìn)行了描述。

.hk當(dāng)前32頁(yè)，總共147頁(yè)。計(jì)算機(jī)系統(tǒng)的驗(yàn)證實(shí)施

工廠驗(yàn)收測(cè)試

工廠驗(yàn)收測(cè)試在系統(tǒng)實(shí)施完成之后在系統(tǒng)供應(yīng)商的場(chǎng)地進(jìn)行。工廠驗(yàn)收測(cè)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(cè)試的另一個(gè)優(yōu)點(diǎn)在于能夠盡早地檢測(cè)到軟件編程中所存在的錯(cuò)誤，以在客戶現(xiàn)場(chǎng)安裝系統(tǒng)之前將其糾正?？蛻魬?yīng)到場(chǎng)檢查/見(jiàn)證工廠驗(yàn)收測(cè)試的執(zhí)行。現(xiàn)場(chǎng)驗(yàn)收測(cè)試-安裝確認(rèn)現(xiàn)場(chǎng)驗(yàn)收測(cè)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(chǎng)驗(yàn)收測(cè)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?，F(xiàn)場(chǎng)驗(yàn)收測(cè)試-運(yùn)行確認(rèn)SAT-OQ屬于現(xiàn)場(chǎng)驗(yàn)收測(cè)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(lái)負(fù)責(zé)進(jìn)行。必須要證明系統(tǒng)根據(jù)技術(shù)說(shuō)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(cè)試之外，IQ中需要包括一些由客戶所增加的測(cè)試。

.hk當(dāng)前33頁(yè)，總共147頁(yè)。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(lái)負(fù)責(zé)進(jìn)行。必須要證明系統(tǒng)具有符合技術(shù)說(shuō)明的正確功能。除了SAT-OQ中已經(jīng)進(jìn)行的測(cè)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(cè)試。確認(rèn)報(bào)告確認(rèn)報(bào)告匯總出了各單一測(cè)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(cè)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(gè)結(jié)果，并說(shuō)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(xiě)?？勺匪菥仃嚫鶕?jù)GAMP5，應(yīng)建立以文件形式記錄要求與說(shuō)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(cè)試之間的可追溯性的流程。所有要求都必須在說(shuō)明文件及測(cè)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(gè)項(xiàng)目過(guò)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。

.hk當(dāng)前34頁(yè)，總共147頁(yè)。.hkAny

question?當(dāng)前35頁(yè)，總共147頁(yè)。.hkGAMP5Software

&

Hardware

Categories軟件和硬件類別當(dāng)前36頁(yè)，總共147頁(yè)。Category類別TypicalApproach典型方法1,StandardHardwareComponents標(biāo)準(zhǔn)硬件部件?Documentmanufacturerorsupplierdetail,serialnumberandversionnumber?通過(guò)文件記錄下生產(chǎn)廠家或供應(yīng)商的詳情、序列號(hào)和版本號(hào)?Correctinstallationtobeverified?確認(rèn)正確的安裝?ConfigurationManagementandChangecontrolapply?適用配置管理和變更控制2,CustomBuiltHardwareComponents定制制造的硬件部件Asperaboveplus:上述內(nèi)容再加上：?Designspecification?設(shè)計(jì)說(shuō)明?Acceptancetesting?驗(yàn)收測(cè)試?ConfigurationandChangecontrolapply?適用配置和變更過(guò)控制.hkGAMP

5

Hardware

Categories

硬件類別當(dāng)前37頁(yè)，總共147頁(yè)。Category類別Description說(shuō)明Typicalexamples典型示例TypicalApproach典型方法1,InfrastructureSoftware基礎(chǔ)設(shè)施軟件?Layeredsoftware分層式軟件?Softwareusedtomanagetheoperatingenvironment用于管理操作環(huán)境的軟件?Operatingsystems操作系統(tǒng)?Databaseengines數(shù)據(jù)庫(kù)引擎?Middleware中間件?Programminglanguages編程語(yǔ)言?Spreadsheets電子制表軟件?Versioncontroltools版本控制給你工具?Networkmonitoringtools網(wǎng)絡(luò)監(jiān)控工具Recordversionnumber,verifycorrectinstallationbyfollowingapprovedinstallationprocedure記錄版本號(hào)，按照所批準(zhǔn)的安裝規(guī)程驗(yàn)證正確的安裝方式。3,Non-configured非配置軟件?Runtimeparametersmaybeenteredandstored,butthesoftwarecannotbeconfiguredtosuitthebusinessprocess?可以輸入并儲(chǔ)存運(yùn)行參數(shù)，但是并不能對(duì)軟件進(jìn)行配置以適合業(yè)務(wù)流程?Firmwarebasedapplications基于固件的應(yīng)用程序?COTssoftwareCOTS軟件?AbbreviatedLifecycleapproach?簡(jiǎn)化的生命周期法?URS用戶需求說(shuō)明?Riskbasedapproachtosupplierassesment?基于風(fēng)險(xiǎn)的供應(yīng)商評(píng)估方?Recordversionnumber,verifycorrectinstallation?記錄版本號(hào)，驗(yàn)證正確的安裝方式?Riskbasedtest基于風(fēng)險(xiǎn)進(jìn)行測(cè)試?Procedureinplaceformaintainingcompliance有用于維持系統(tǒng)符合性的規(guī)程.hkGAMP

5

Software

Categories

軟件類別當(dāng)前38頁(yè)，總共147頁(yè)。Softwarethe

.hkGAMP

5

Software

Categories

軟件類別Category類別4,configured

可配置Description說(shuō)明Software,often

verycomplex,thatcan

beconfigured

bytheusertomeetthespecificneedsoftheuser’sbusinessprocess.Software

codeisnotaltered這種軟件通常非常復(fù)雜，可以由用戶來(lái)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。Typical

examples典型示例?DAQ

systems?SCADA?DCS?BMS?HMI?LIMS?ERP?Clinical

trailmonitoringTypical

Approach典型方法?Life

cycle

approach生命周期法?Riskbasedapproachto

supplier

assessment基于風(fēng)險(xiǎn)的供應(yīng)商評(píng)估法?SupplierQMS供應(yīng)商的質(zhì)量管理系統(tǒng)?Recordversion

number,

verify

correctinstallation記錄版本號(hào)，驗(yàn)證正確的安裝方式?Risk

basedtestingina

test

environment在測(cè)試環(huán)境中根據(jù)風(fēng)險(xiǎn)進(jìn)行測(cè)試?Risk

based

testingwithin

thebusinessprocess在業(yè)務(wù)流程中根據(jù)風(fēng)險(xiǎn)進(jìn)行測(cè)試?Procedurein

placefor

maintainingcompliance具有維持符合性的規(guī)程5,

Custom定制?Internally,customexternally

developeddesignedand

IT

applications.內(nèi)部codedto

suit和外部開(kāi)發(fā)的IT應(yīng)用程

business

序processSameas

cat4

plus與第4類相同，再加上?More

rigoroussupplierassessment,

withpossiblesupplier

audit更嚴(yán)格的公用設(shè)施評(píng)估，包括可能進(jìn)行供應(yīng)商審計(jì)?Possessionof

full

lifecycle

完整的生命周當(dāng)前39頁(yè)，總共147頁(yè)。.hkSoftware

Category

3

第3類軟件當(dāng)前40頁(yè)，總共147頁(yè)。.hkSoftware

Category

4

第4類軟件當(dāng)前41頁(yè)，總共147頁(yè)。.hkSoftware

Category

5第5類軟件當(dāng)前42頁(yè)，總共147頁(yè)。.hkGAMP5

Planning

Phase

計(jì)劃階段URS用戶需求說(shuō)明當(dāng)前43頁(yè)，總共147頁(yè)。User

Requirement

Specification用戶需求說(shuō)明???????Most

importantdocument最重要的文件Describeswhat

thesystem

issupposed

to

do描述系統(tǒng)預(yù)期用途Normally

writtenby

theSupplier

通常由供應(yīng)商編寫(xiě)ControlledDocument

受控文件ForCat3

writtenfora

specificsolution第3類針對(duì)具體解決方案編寫(xiě)For

Cat

4&5Itis

writtenin

general

第4、5類整體編寫(xiě)Sufficient,

Realistic,Measurable,Achievable充分、現(xiàn)實(shí)、可衡量、可

達(dá)到?

Testable:Clear,

Precise,

basisfor

formal

testing可測(cè)量：清楚、簡(jiǎn)潔、

正式測(cè)試的基礎(chǔ)?Traceable:

Designandtesting可追溯：設(shè)計(jì)和測(cè)試?Define

priority:

Mandatory,Beneficial,

Nice

to

have

規(guī)定優(yōu)先級(jí)：必須、

有益、有了更好

.hk當(dāng)前44頁(yè)，總共147頁(yè)。.hkURS-Content

用戶需求說(shuō)明-內(nèi)容?

Introduction:

介紹–

Whoproduced

the

document

文件編寫(xiě)人–Contractual

status

合同狀態(tài)

–

Relationshiptoother

document與其它文件關(guān)系?

Overview:Background

to

the

project概述：項(xiàng)目背景?

Scope:

范圍–

System

boundaries

系統(tǒng)范圍–Key

objectiveand

benefits

關(guān)鍵目標(biāo)和益處–Applicable

GXPrequirement適用GXP要求–Other

applicable

regulations

其它適用法規(guī)當(dāng)前45頁(yè)，總共147頁(yè)。.hkURS-Content:

Operational

RequirementURS-內(nèi)容：操作要求?

Functions功能–

What

is

the

system

require

to

do

系統(tǒng)要求的功能–Calculations計(jì)算–

Modes

of

operation

(UseCases)

操作模式（使用示例）–

Alarms報(bào)警–Failure

Modes

故障模式–

Safety安全–ElectronicsRecords,

Audit

Trail,

&

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)文件等當(dāng)前46頁(yè)，總共147頁(yè)。URS-Content:

Operational

RequirementURS-內(nèi)容：操作要求?

Data數(shù)據(jù)–Datahandling

requirement

(Paper,Electronics)數(shù)據(jù)處理要求（物理版、電

子版）–Data

impact數(shù)據(jù)影響–

Definition

ofdata:format,

critical

parameters,data

rangelimits,

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–Electronics

Records,AuditTrail,&

Electronics

Signature電子記錄、審計(jì)跟

蹤、電子簽名–

Reports,data

files,

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)–

Archive

requirement存檔要求–

Data

Security

andintegrity

數(shù)據(jù)安全和完整性

.hk當(dāng)前47頁(yè)，總共147頁(yè)。.hkURS-Content:

Operational

RequirementURS-內(nèi)容：操作要求?

Technical

requirement技術(shù)要求–Startup,

shutdown,Cold

start,Warmstart,

Hot

start啟動(dòng)、停機(jī)、冷起、暖起、熱起–Disasterrecovery災(zāi)難恢復(fù)–Performance

andtimingrequirement性能和計(jì)時(shí)要求–ActiononComponent

failure

對(duì)部件故障的措施–Hardwarerequirement

硬件要求–

Portability

便攜性–

Efficiency

效率–Configurability

可配置性當(dāng)前48頁(yè)，總共147頁(yè)。

URS-Content:

Operational

Requirement

URS-內(nèi)容：操作要求?

Interfaces

界面

–I/O

listing

–I/O列表

–Interfaceto

othersystems/equipment

–

與其它系統(tǒng)/設(shè)備界面

–

HMI

–

Usersgroupsandtheir

accessrights

–

用戶組及其訪問(wèn)權(quán)限

–

Network

protocols

supported: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

.hk當(dāng)前49頁(yè)，總共147頁(yè)。.hkURS-ContentURS-內(nèi)容：?

Constraints

限制條件–Availability(

redundancy?)

&

reliability–可用性（冗余？）和可靠性–

Expansion

capability–

擴(kuò)展容量–

Future

expansion–

未來(lái)擴(kuò)展–Expected

life

time–預(yù)期使用壽命–

Longterm

support–長(zhǎng)期支持當(dāng)前50頁(yè)，總共147頁(yè)。

URS-Content

URS-內(nèi)容：?

Life

Cycle

requirement

生命周期要求

–Development

requirement:GAMP5

–

開(kāi)發(fā)要求：GAMP5

–

SupplierQuality

requirement

–供應(yīng)商質(zhì)量要求

–

Documentation

requirement––––文件要求Testing

Requirement:

Internal

testing,

FAT,

SAT測(cè)試要求：內(nèi)部測(cè)試、FAT、SATTraining–培訓(xùn)–Support

and

maintenance

service–

支持和維護(hù)服務(wù)–Spares–

備件

.hk當(dāng)前51頁(yè)，總共147頁(yè)。.hkAny

question?當(dāng)前52頁(yè)，總共147頁(yè)。.hkGAMP5

Planning

PhaseGAMP5計(jì)劃階段Quality

and

Project

Plan質(zhì)量及項(xiàng)目計(jì)劃當(dāng)前53頁(yè)，總共147頁(yè)。.hkQuality

Plan質(zhì)量計(jì)劃?A

Quality

Planis

akey

document

in

defining

theprojectlifecycle.

Itsetsout

the

proposed

method

ofmeetingtheuser

quality

requirements

and

allows

agreement

of

the

controlling

proceduresfor

eachproject

activity.?質(zhì)量計(jì)劃是一個(gè)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。?QualityPlanis

the

responsibility

ofthe

supplier?

質(zhì)量計(jì)劃屬于供應(yīng)商的責(zé)任?It

shouldnormally

be

supplied

withinthe

firstweek

of

signing

contract.?一般需在簽訂合同之后一周內(nèi)提供?

It

iswritten

in

response

to

ValidationPlan?應(yīng)作為對(duì)驗(yàn)證計(jì)劃的響應(yīng)而編寫(xiě)?

Itneeds

to

be

approved

byUser.?

需要由用戶來(lái)批準(zhǔn)?Generallyonceapproved

should

not

requirefurther

revision.?一般批準(zhǔn)之后不需再進(jìn)行修訂當(dāng)前54頁(yè)，總共147頁(yè)。.hkQP-

Contents

QP-內(nèi)容?

Relationship

to

other

Documents

與其它文件關(guān)系–Applicable

standard適用標(biāo)準(zhǔn)–Relationshipto

customerValidation

Requirements與客戶驗(yàn)證要求之間關(guān)系–Non-ConformancewithUser

Requirement

與用戶需求的不符合項(xiàng)–

Relationshipt?

Project

overview

項(xiàng)目概述–Summary

ofProcesstobe

controlled所需控制工藝概述–Relevant

GxP

regulations

相關(guān)GxP法規(guī)–Impact

onPatient

Safety,ProductQuality,data

integrity對(duì)患者安全、產(chǎn)品質(zhì)量和數(shù)據(jù)完整性的影響–

Project

boundariesand

interfaces

(scopeof

supplyandvalidation項(xiàng)目范圍和接口（供貨范圍和驗(yàn)證）–SystemArchitecture系統(tǒng)結(jié)構(gòu)–

System

classification:Hardware

and

software

categories系統(tǒng)分類：硬件和軟件類別當(dāng)前55頁(yè)，總共147頁(yè)。QP-Contents

QP-內(nèi)容?

Project

Life

Cycle

phases項(xiàng)目生命周期階

段–

It

should

follow

GAMP5

LifeCycle

model

應(yīng)遵循GAMP5所規(guī)定生命周期

模型–List

whatactivities

willbe

performed

列出所需進(jìn)行工作–

Defines

whowill

be

responsiblefor

executing

eachactivity

確定執(zhí)行每項(xiàng)

工作的負(fù)責(zé)人–The

levelofactivity

dependsonthe

degreeof

novelty

工作的內(nèi)容取決于

新穎性程度–

Dependingon

thesizeand

complexity,some

documentsmaybe

merged

into

a

singleone根據(jù)規(guī)模和

復(fù)雜性，有些文件可以合為一個(gè)文件–Documentscreated

needto

bereviewedand

approvedby

end

user所編寫(xiě)文件需要由最終用戶審核批準(zhǔn)

.hk計(jì)劃

技術(shù)說(shuō)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)的支持性流程當(dāng)前56頁(yè)，總共147頁(yè)。.hkQP-Contents

–

Project

Life

CycleQP-內(nèi)容-項(xiàng)目生命周期?

Planning

Phase計(jì)劃階段–Review

ofURS–審核URS–Creation

ofProjectschedule

and

approval–編制并批準(zhǔn)項(xiàng)目進(jìn)度時(shí)間表–Creationof

QualityPlanand

approval–編寫(xiě)和批準(zhǔn)質(zhì)量計(jì)劃當(dāng)前57頁(yè)，總共147頁(yè)。.hkQP-Contents

–

Project

Life

CycleQP-內(nèi)容-項(xiàng)目生命周期?

Specification

Phase

技術(shù)說(shuō)明階段–Creation

ofFunctionalDesign

and

Approval–編寫(xiě)并批準(zhǔn)功能設(shè)計(jì)說(shuō)明–

Creationof

Hardware

DesignincludingDrawingsand

approval–

編寫(xiě)并批準(zhǔn)硬件設(shè)計(jì)說(shuō)明，包括圖紙–Risk

Assessment–風(fēng)險(xiǎn)評(píng)估–

CreationofSoftware

Design

andapproval–編寫(xiě)并批準(zhǔn)軟件設(shè)計(jì)說(shuō)明–CreationofSoftwareModule

design

and

approval–

編寫(xiě)并批準(zhǔn)軟件模塊設(shè)計(jì)說(shuō)明當(dāng)前58頁(yè)，總共147頁(yè)。LifecyclePhase生命周期階段Infrastructuresoftwareelement基礎(chǔ)設(shè)施軟件組件Non-configuredsoftwareelement不可配置軟件組件Configuredsoftwareelement可配置軟件組件Bespokesoftwareelement定制軟件組件Specification技術(shù)說(shuō)明FunctionalSpecification(mayalsodetaildesignandconfigurationonasimple/lowrisksystem)功能說(shuō)明（對(duì)于簡(jiǎn)單/低風(fēng)險(xiǎn)系統(tǒng)也可詳細(xì)描述設(shè)計(jì)和配置情況）HardwareDesignandConfigurationSpecificationifjustifiedbyHIGH/MEDIUMriskpriorityorbythecomplexityofthehardware如根據(jù)高/中風(fēng)險(xiǎn)優(yōu)先級(jí)別或硬件的復(fù)雜性判定需要，編寫(xiě)硬件設(shè)計(jì)說(shuō)明和配置說(shuō)明SoftwareDesignandConfigurationSpecificationifjustifiedbyHIGH/MEDIUMriskpriorityorbythecomplexityofthesoftware如根據(jù)高/中風(fēng)險(xiǎn)優(yōu)先級(jí)別或軟件的復(fù)雜性判定需要，編寫(xiě)軟件設(shè)計(jì)說(shuō)明和配置說(shuō)明SoftwareModuleSpecificationifjustifiedbyHIGH/MEDIUMriskpriorityorbythecomplexityofthesoftware如根據(jù)高/中風(fēng)險(xiǎn)優(yōu)先級(jí)別或硬件的復(fù)雜性判定需要，編寫(xiě)軟件模塊設(shè)計(jì)說(shuō)明Forallcategoriesofsoftware,settingsandparameterswhicharecriticaltomeetinguserrequirementsaredetailedwithinthedocumentation.Allothersettingsandparametersarecontrolledelectronicallyviabaselinesofthesoftwaretakenpriortoeachverificationphaseandatprojecthandover.The‘a(chǎn)shandedover’settingsandparametersaresuppliedtotheenduserwithinthesoftwarebaselineonCD/DVD.Subsequentmodificationsmadeon-linearecontrolledviatheaudittrail.Subsequentmodificationsmadeoff-linearecontrolledviatheconfigurationmanagementsystemandresultinanewbaselinebeingtaken.針對(duì)所有類別的軟件，在文件中詳細(xì)說(shuō)明符合用戶需求所需的關(guān)鍵設(shè)定和