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!