A Practical Guide

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Dec 2, 2013 (3 years and 11 months ago)

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Software Validation in
Accredited
Laboratories

A Practical Guide


Greg Gogates

Fasor Inc.

gdg@fasor.com

26 Sept 2001

A copy of this paper will be maintained on ftp.fasor.com/pub/iso25/validation/

26 Sept 2001

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Preamble


ISO guide 25 “Adequate for Use”


ISO 17025 “Suitably Validated”


Validation
-

Reasonable Assurance


Maintain Design Control


Know what's where!


Keep it Simple


EA/GA(98)95 Draft

“EA Guidelines for the use of
Computers and Computer Systems in Accredited Laboratories”


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Software Classifications


COTS
-

Commercial Off the Shelf



MOTS
-

Modified Off the Shelf



CUSTOM
-

Written from scratch

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COTS


Use as delivered


No modifications/customizations


Verify functionality


Verify menu contents


Verify parameter files


Lock down changes


Installation checkout

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MOTS


Needs configuration/customization prior
to use.


Customizations require validation.


Non
-
modified portion treated as COTS


Installation checkout.


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CUSTOM


Home Brew or Consultant code


Functional Requirements


Software Design


Traceability Matrix


Structural / Functional Tests


Installation Checkout

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Software Life Cycle

Requirements
Design
Construction
Testing
Configuration management
Installation/
Checkout
Traceabiliity
Matrix
Quality System
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Products / Systems

Computer
System 1
Computer
System 2
Software
Product A
Software
Product C
Software
Product B
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Software

Configuration Management


What software is on what machine


Store originals on Network Share,
Tape, or CD
-
R


Maintain all published versions


Control Access


Ensure user access

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Documentation
Configuration Management


Evidence of validation


Evidence of adequate for use


Owners / User manuals


Software Lifecycle documents


Test Evidence

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Good Practices
-

1


Treat each software product a piece of
calibration equipment.


Do checks to ensure nothing changes.


Place software product masters in a
read only directory.


Network computers that access a
shared program on a server.

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Good Practices
-

2


Lock spreadsheet cells that contain math.


Password protect configuration files or setup
screens.


Backup, back
-
up, and backup off site!


Plan for hardware/software disaster recovery.


Good information maintained @
ftp://ftp.fasor.com/pub/iso25/validation

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Software Checklist
-

1

1.
Has the Firmware been validated via the calibration by a cal lab who has the capability to
thoroughly check the software (i.e. OEM or Authorized partner) (Note: for non
-
calibratable device
Firmware, treat as Software)


2.
Have all of the "used" firmware parameters been documented and confirmed that they are correct?


3.
Does a Software Requirements document exist for the Software?


4.
Does a Software Design document exist detailing either the full design or details of the
configuration?


5.
Does software testing documents exists describing completed, unique, test cases that exercise the
design both +/
-

and confirms the requirements?


6.
Is there a test log showing test failures and corresponding retests/dispositions?


7.
Does evidence exist confirming correct software deployment at each target installation? [5.5.11]

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Software Checklist
-

2

8.
Has configuration control been applied to all of their Software/Firmware to ensure that: [4.12.1.4]


a)
The Software source code location is access controlled. [5.4.7.2.b]


b)
Firmware/Software formulas & parameters are "locked" to prevent inadvertent changes. [5.5.12]


c)
Equipment lists identify Software as a separate line item showing correct version and location. [5.5.5]


9.
Does evidence exist showing that personnel involved in Custom Software development have
adequate training?


10.
Do Databases and spreadsheets include "audit trails" to not allow previously data to be obscured?
[4.12.2.3]


11.
Do adequate instructions exist for the operation & maintenance of the Software? [5.4.1]


12.
Does the accuracy of the Firmware/Software meet or exceed the accuracy required by the test
method? [5.5.2]

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Confirm
Purchased
Product Meets
Requirements
Software Desired
Confirm
Purchased
Product Meets
Requirements
Define Design
What Type
CUSTOM
MOTS
COTS
Verify User
Parameters
Build
Customizations/
Modifications
Build Code
Define
Requirements
Test Product
Install
Product onto
System(s)
Validation
S


U


M


M


A


R


Y

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QUESTIONS?

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