This document discusses change control and configuration management. It defines change control as a formal process for introducing changes to a product or system in a controlled manner. It discusses what constitutes a change versus no change. It emphasizes the importance of change control and having clearly defined change processes. It also discusses configuration management as maintaining consistency of a product's attributes and requirements. It provides examples of configuration management and discusses where configurations are typically documented. It stresses the importance of having configurations under change management and understanding how configurations relate to each other.

1. Change Control and Configuration Management
IVT 18th Annual Validation Week
R. Hinkel

2. Agenda
• Change Control
– What is it?
– Change or No Change
– Why Do you Care?
– How Many Do You Have?
– How Many Is Too Many
– Musts
• Configuration Management
– What is it?
– Why Do You Care?
– Examples
– Where is it Found?
– Musts

3. Change
Control
–
What
Is
it?
• Defini6on
–
A
formal
process
used
to
ensure
that
changes
to
a
product
or
system
are
introduced
in
a
controlled
and
coordinated
manner.
• Addi6ons
• Dele6ons
• Modifica6ons
• Re6re

4. Change
Control
(Change
or
No
Change)
• Are
the
Following
Changes
or
No
Changes
– Replacing
Like
for
Like
Equipment
– Upda6ng
SoKware
– Removing
a
User
from
a
IT
System
– Changing
Filters
(Different
Material
Composi6on)
– Your
Examples…
• Recommenda6on:
Include
Rules
(Examples)
in
your
Change
Control
SOP.

5. Change
Control
–
Why
Do
You
Care?
• Change
Costs
Money
– Takes
Time
– Takes
Resources
• May
Cause
Confusion
– May
Impact
Morale
• What
is
Your
Company’s
Tolerance?
– Resources
Available
to
Make
Changes
– Response
to
Customer
Needs
/
Wants
• It’s
the
Law
• Change
Control
Can
Either
Help
or
Hurt
Your
Reputa6on

6. Change
Control
-­‐
How
Many
Do
You
Have?
• Companies
Rarely
Just
Have
One
• Examples
– Document
Control
– Engineering
Control
– Design
Control
– IT
Change
Control
• How
Many
Does
Your
Company
Have?
• Recommenda6on:
Op6mize
the
Number
of
Change
Process.

7. Change
Control
–
How
Many
Is
Too
Many?
• Depends
on:
– Do
the
Processes
“Talk”
to
One
Another
– Are
the
Processes
Documented
and
Controlled
Preven6ng:
• Overlap
• User
Community
Confusion
• Some
Changes
Not
Being
Captured
– What
Is
the
Rela6onship
Between
Processes
• Peer
to
Peer
• Parent
to
Child
• Other
Quality
Processes
(CAPA,
Devia6ons,
etc…)

8. Change
Control
–
Musts
• Define
and
Control
Your
Change
Processes
– Scope
– Document
the
Process
(Flow
Charts
are
Helpful)
– Rela6onship
With
Other
Processes
– Metrics
– Timelines
– Deadline
Extension
Process
• Guidance
to
User
Community
– What
Process
to
Use
When
– Examples
(What
is
/
What
is
Not
a
Change)
– Set
Wriben
Rules

9. Configura6on
Management
–
What
is
it?
• (CM)
is
a
process
for
establishing
and
maintaining
consistency
of
a
product’s
performance
and
func6onal
and
physical
abributes
with
its
requirements,
design
and
opera6onal
informa6on
throughout
its
life.
1-­‐-­‐Wikipedia
• Product
=
Equipment
,
Systems,
SoKware,
etc…

10. Configura6on
Management
–
Why
Do
You
Care?
• Unregulated
Configura6ons
Changes
Can
Lead
to
“Surprises”
– Loss
of
Service
– Security
Breaches
– Can
You
Name
Some?
• Properly
Maintaining
Configura6ons
Requires
Money
(Time,
Resources)

11. Configura6on
Management
-­‐
Examples
• Car
Radio
Pre-­‐set
Sta6ons
• Car
Mirror
Seengs
• Security
Profiles
• SoKware
Configura6on
“Turning
On
/
Off”
func6onality
and
features
• Can
You
Name
Some
Examples?

12.
Configura6on
Management
–
Where
is
it
Found?
• Within
Valida6on
Documenta6on
(IQ,
OQ,
PQ)
• Within
Engineering
Documenta6on
• Within
Design
Documenta6on
• Within
Separate
CM
system
• Within
the
System
SoKware
• Can
You
Name
Any
Others?

13. Configura6on
Management
–
Musts
• Must
Know
Where
They
are
Documented?
• Must
Have
Them
Under
Change
Management
• Must
be
able
to
Link
Configura6on
Seengs
to
Tes6ng.
• Must
Understand
the
Rela6onship
Between
Different
Configura6on
Seengs
within
a
System

14.
Thank You!