Validation Part5

7/21/2019 Validation Part5

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Validation | Slide 1 of 31 August 2006

Validation

Supplementary Training Modules onGood Manufacturing Practice

WHO Technical Report Series,No !"#, $%%& 'nne( )


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Validation

Part 1. General overview on qualification and validation

Part 2. Qualification of HVAC and water systems

Part 3. Cleaning validation

Part . Analytical met!od validation

Part * +omputeried system -alidation

Part ". Qualification of systems and equi#mentPart $. %on sterile #roduct #rocess validation


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+omputeried systems -alidation

Part *

Supplementary Training Modules on

Good Manufacturing Practice

WHO Technical Report Series,

No !"#, $%%& 'nne( ) 'ppendi( *


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Validation

O./ecti-es

To discuss -alidation of computeried systems including0

&ystem s#ecifications

'unctional s#ecifications&ecurity

(ac)*u#s

Validation+

, Hardware, Software


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Validation

GeneralValidated * level a##ro#riate

, or their use and application.

Production and quality control.

Com#uter systems used in #lanning- s#ecification-

#rogramming- testing- commissioning- document o#eration-

monitoring and modifying.

Validation+ vidence and confidence, intended use, accuracy, consistency and reliability.

11 2 1"


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Validation

General 3$4

(ot! t!e system s#ecifications and functional

s#ecifications s!ould /e validated.

Periodic 0or continuous evaluation s!ould /e #erformed

after t!e initial validation.

1) 2 1*


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Validation

ritten #rocedures for+, performance monitoring, change control, programme and

data security, calibration and maintenance, personneltraining, emergency recovery and periodic re-evaluation

uring validation- consider+, networks, manual back-ups, input/output checks, process documentation, monitoring

, alarms, and, shutdown recovery

1& 2 1#


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Validation

System specification 3+ontrol document4 4n #lace- stating+

, objectives of a proposed computer system

, the data to be entered and stored

, the flow of data, how it interacts with other systems and procedures

, the information to be produced

, the limits of any variable

, the operating programme and test programme

(Examples of each document produced by the programme

should be included) $1


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Validation

System specification 3+ontrol document4 3$4

&ystem elements t!at need to /e considered in com#uter

validation include+

, hardware (euipment!, software (procedures!

,people (users!

$$


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Validation

5unctional specification 3Performance specification4

Provide instructions for+

, testing, operating, and maintaining the system

, names of the person(s! (development and operation!

!en using com#uter systems- consideration+, location

, power supply

("luctuations in the electrical supply can influence computersystems and power supply failure can result in loss of

memory!., temperature

, magnetic disturbances "1 2 "$


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Validation

5unctional specification 3Performance specification43$4

G5P requirements for com#uter systems+

Verification and re-alidation, #fter a suitable period of running a new system

, $ndependently reviewed and compared with the systemspecification and functional specification +hange control

, #lterations made in accordance with a defined procedure, %rovision for checking, approving and implementing the

change

+hec6s, &ata checked periodically, 'onfirm accurate and reliable transfer "$ 2 ""


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Validation

Security

Production as well as in quality control

ata entered or amended * aut!ori6ed #ersons

&ecurity systems to #revent unaut!ori6ed entry or mani#ulation

of data

&7Ps for entering data- c!anging or amending incorrect entries

and creating /ac)*u#s

&ecurity #rocedures in writing)1 2 )"


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Validation

(continued)

8racea/ility is of #articular im#ortance

Audit trail+

, identify the persons who made entries

, identify the persons who made changes

, identify the persons who released material

, identify the persons who performed other critical steps in

production or control

))


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Validation

7ac68ups9egular /ac)*u#s of all files and data

, Secure storage (prevent intentional or accidental damage!

ValidationValidation #rocess s!ould include+

, %lanning

, alidation policy

, %roject plan and S)%s

*1 2 &1


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Validation

Validation 3$4

efine com#uter*related systems and vendors

Vendor and #roduct evaluated

&ystem designed and constructed

, 'onsider types, testing and uality assurance of the

software

:tent of qualification de#ends on com#le:ity of t!e system

&$


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Validation

Validation 3"4

Qualification includes+

4nstallation

valuation of t!e system

Performance

C!ange control- maintenance and cali/ration- security-

contingency #lanning- &7Ps- training- #erformance monitoring

and #eriodic re*evaluation

&"


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Validation

Validation of hard9are

A##ro#riate tests and c!allenges to t!e !ardware

%o influence of static- dust- #ower*feed voltage fluctuations and

electromagnetic interference

Hardware is considered to /e equi#ment

, focus on location, maintenance and calibration as part of

the ualification

#11 2 #1$


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Validation

Validation of hard9are 3$4

4t s!ould #rove+

A##ro#riate ca#acity

7#erational limits

, e.g. memory, connector ports, input ports

Performance under worst*case conditions

, e.g. long hours, temperature e*tremes

9e#roduci/ility;consistency

, e.g. by performing at least three runs under differentconditions

#1"


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Validation

Hard9are types

:istri.ution

system

Peripheralde-ices

Signal con-erter

+entral

Processing

;nit


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Validation

>ey aspectsTo consider

+ommand

o-errides

Maintenance Signalcon-ersion


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Validation

Validation

Reproduci.ility

+onsistencyand

documentation

@imits

Worst case

Re-alidation 5unction

Summary0 Validation re=uirements for Hard9are 3See Ta.le 1 in notes4


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Validation

Validation of Soft9are&oftware+

is t!e term used to descri/e t!e com#lete set of #rogrammes

used /y a com#uter- and w!ic! s!ould /e listed in a menu

9ecords are considered as software

'ocus s!ould /e #laced on+

, accuracy, security, access, retention of records, review,

double checks, documentation and accuracy ofreproduction

#$1 2 #$$


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Validation

=ey com#uter #rogrammes to /e identified+

, language, name, function (purpose of the programme!

, input (determine inputs!, output (determine outputs!

, fi*ed set point (process variable that cannot be changed by the

operator!, variable set point (entered by the operator!

, edits (reject input/output that does not conform to limits and

minimi+e errors, e.g. four- or five-character number entry!, input

manipulation (and euations! and programme overrides (e.g. to

stop a mi*er before time!

4dentification of aut!ori6ed #ersonnel

, to write, alter or have access to programmes #$" 2 #$)


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Validation

Validation of Soft9are 3$4 Points to .e considered may include0

, 'onsistency in performance ithin pre-established limits!

, "unction atching the assigned operational function (e.g.generate batch documentation, different batches of materialused in a batch listed!

, orst case alidation under different conditions (e.g.speed, data volume, freuency!

, epeats Sufficient number of times (e.g. replicate dataentries!

, &ocumentation %rotocols and reports

, evalidation $n case of significant changes made#$*


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Validation

@e-el

High le-el

language

'ssem.ly

language

'pplication

language

Machine

language

Summary0 Validation re=uirements for Soft9are 3See Ta.le 1 in notes4


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Validation

>ey aspects

Soft9are

de-elopment

Soft9are

security



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Validation

Validation

Repeats

Worst case

:ocumentation

Re-alidation

5unction



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Validation

Grou# session

Documents

Validation Part5