Verification and validation

November 9th 2016

Copyright © 2016 BSI. All rights reserved.

1
Trev and Spike present the
definitive guide to
Verification and validation
 Objectives

Descriptions and definitions

Examples
ISO 13485:2016 requirements
Use of Statistics

3
Verification (BS EN ISO 9001:2015)

3.8.12
confirmation, through the provision of objective
evidence that specified requirements have been
fulfilled.
Any set of criteria can be subjected to verification.

VERIFICATION: Did we make what we said we would make?

Validation (BS EN ISO 9001:2015)

3.8.13
Confirmation, through the provision of objective
evidence, that the requirements for a specific intended
use or application have been fulfilled.
The intended purpose is achieved, validation.

Does it do what it says on the tin?

Quality (BS EN ISO 9001:2015)

3.6.2
degree to which a set of inherent characteristics of an object fulfils
requirements.
What to conduct V&V on…..
Design
Transfer
Process
Packaging
Product
 Relationship, Risk and V&V

Product verification (test)

Valid interval
RISK

Product verification (test)

Valid interval
RISK

Time

Product verification (test)

Valid interval
RISK

Product verification (test)

 V&V Examples

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Sterilisation
Software verification EN ISO 62304
5.1.6 The MANUFACTURER shall include or reference in the software
development plan the following VERIFICATION information:
a) DELIVERABLES requiring VERIFICATION;
b) the required VERIFICATION TASKS for each life cycle ACTIVITY;
c) milestones at which the DELIVERABLES are VERIFIED; and
d) the acceptance criteria for VERIFICATION of the DELIVERABLES.
Software Validation EN ISO 62304

This standard does not cover validation and final release of the
MEDICAL DEVICE, even when the MEDICAL DEVICE consists entirely of
software.
Processes which cannot be verified
• Welding
• Soldering
• Aseptic filling
• Packaging
• Gluing/bonding
 V&V and ISO 13485

Overview
Design
Software
Special processes

Copyright © 2016 BSI. All rights reserved.

ISO 13485 Audits.
7.3.2 Design and development planning
During design and development planning, the organization
shall document: ……

c) the verification, validation, and design transfer activities

that are appropriate at each design and development stage;
7.3.6 Design and development verification
Design and development verification shall be performed in accordance
with planned and documented arrangements to ensure that the design
and development outputs have met the design and development input
requirements.
The organization shall document verification plans that include
methods, acceptance criteria and, as appropriate, statistical techniques
with rationale for sample size.
7.3.6 Design and development verification
(Continued)
If the intended use requires that the medical device be connected to,
or have an interface with, other medical device(s), verification shall
include confirmation that the design outputs meet design inputs when
so connected or interfaced.
Records of the results and conclusions of the verification and necessary
actions shall be maintained (see 4.2.4 and 4.2.5).
7.3.7 Design and development validation

Design and development validation shall be performed in accordance

with planned and documented arrangements to ensure that the
resulting product is capable of meeting the requirements for the
specified application or intended use.
The organization shall document validation plans that include methods,
acceptance criteria and, as appropriate, statistical techniques with
rationale for sample size.
7.3.7 Design and development validation
(Continued)
Design validation shall be conducted on representative product.
Representative product includes initial production units, batches or
their equivalents. The rationale for the choice of product used for
validation shall be recorded (see 4.2.5).
As part of design and development validation, the organization shall
perform clinical evaluations or performance evaluations of the medical
device in accordance with applicable regulatory requirements. A
medical device used for clinical evaluation or performance evaluation is
not considered to be released for use to the customer.
7.3.7 Design and development validation
(…and finally)
If the intended use requires that the medical device be connected to,
or have an interface with, other medical device(s), validation shall
include confirmation that the requirements for the specified
application or intended use have been met when so connected or
interfaced.
Validation shall be completed prior to release for use of the product to
the customer.
Records of the results and conclusion of validation and necessary
actions shall be maintained (see 4.2.4 and 4.2.5).
7.3.8 Design and development transfer
The organization shall document procedures for transfer of
design and development outputs to manufacturing. These
procedures shall ensure that design and
development outputs are verified as suitable for
manufacturing before becoming final production
specifications and that production capability can meet
product requirements.
7.3.9 Control of design and development
changes
Design and development changes shall be identified. Before
implementation, the changes shall be:
a) reviewed;
b) verified;
c) validated, as appropriate;
d) approved.
7.3.10 Design and development files
The organization shall maintain a design and development file for each
medical device type or medical device family. This file shall
include or reference records generated to
demonstrate conformity to the requirements for design and
development and records for design and development changes.
4.1.6 General requirements
The organization shall document procedures for the validation of the
application of computer software used in the quality management
system. Such software applications shall be validated prior to initial use
and, as appropriate, after changes to such software or its application.

The specific approach and activities associated with software validation

and revalidation shall be proportionate to the risk associated with the
use of the software.
7.5.6 Validation of processes for production
and service provision
The organization shall validate any processes for production and service
provision where the resulting output cannot be or is not verified by
subsequent monitoring or measurement ……….
The organization shall document procedures for the validation of the
application of computer software used in production and
service provision. Such software applications shall be validated prior to
initial use and, as appropriate, after changes to such software or its
application. The specific approach and activities associated with software
validation and revalidation shall be proportionate to the risk
associated with the use of the software, including the effect on the
ability of the product to conform to specifications.
7.6 Control of monitoring and measuring
equipment
The organization shall document procedures for the validation of the
application of computer software used for the monitoring
and measurement of requirements. Such software applications
shall be validated prior to initial use and, as appropriate, after changes to
such software or its application. The specific approach and activities
associated with software validation and revalidation shall be
proportionate to the risk associated with the use of the
software, including the effect on the ability of the product to conform to
specifications.
 Use of Statistics

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 What is statistics?
Sample
Statistics

Parameters Population

The science of Statistics is:

Analysis of Statistics, not of Parameters.

Statistics are used to estimate Parameters.

What do we look for?
1. Objective (what is the question to be answered?)
2. Sample (what sampling method?)
3. Analyse the data (what method of analysis?)
4. Draw the correct conclusions
5. Can the conclusions be traced back to the statistics?
Example 1- Collecting good data
• Factory move, to statistically prove their manufacturing process is
validated after the factory move
• Due to large number of products, they chose to justify their answer
by using a representative sample of their whole product range
• Selected their representative sample based on the highest volume
product
Example 1- Collecting good data
• Factory move, to statistically prove their manufacturing process is
validated after the factory move 
• Due to large number of products, they chose to justify their answer
by using a representative sample of their whole product range 
• Selected their representative sample based on the highest volume
product X
Example 2- Analysing the data
• Same manufacturer, same factory move
• Stated they made 200
• Sample size of 57 for testing (90% Confidence Interval, 90%
Reliability), fail on any 1 sample failing
• Stated 4 failed, but 196 passed
• Concluded because 196 passed > 57, then study proves the process is
validated
Example 2- Analysing the data
• Same manufacturer, same factory move

• Stated they made 200

• Sample size of 57 for testing (90% Confidence Interval, 90%

?
Reliability), fail on any 1 sample failing
• Stated 4 failed, but 196 passed

X
• Concluded because 196 passed > 57, then study proves the process is
validated
 Summary
• Verification – does is meet the criteria?
• Validation – does it meet the intended use?
• Quality – the measure of verification and validation
Questions