30 Day Workshop

Manufacturing Equipment/Software Changes

August 28, 2012

On a scale of 1 to 5, please rank your

understanding and comfort level with this topic.

1. Very Comfortable
2. Comfortable
3. Neutral
4. Uncomfortable
5. Very Uncomfortable

37%

28%

27%

5%
2%

Purpose of Presentation
Share AdvaMed subgroup experience
Discuss software change examples
Suggest regulatory path for example changes

Scope:
Manufacturing Equipment Software and Hardware. Will not
be discussing device software.

Advamed Subgroup Observations

Annual Report Review
Collected 27 examples of Annual Report items converted to 30 Day Notice
Significant confusion on equipment hardware and software changes (17 of
27 examples)
Opportunities for Improvement
1.Reduce confusion on which equipment changes are acceptable in the
Annual Report and which require a 30 Day Notice
2.Improve consistency in decision making

Poll 1a: In the past year, how many equipment (hardware

and software) changes have you had converted from an
Annual Report item to a 30 Day Notice?
48%

1.
2.
3.
4.

40%

0
1-5
6-10
11 or more

7%

5%

Evaluating the Risk of Software Changes

1.
2.
3.
4.

Does the software directly affect the manufacturing process?

Does the change impact a process control?
Does the change impact accept/reject activities?
Are you changing the specifications or process parameters?

Software Validation
A manufacturers Quality System may require a partial or full software
verification/validation for a change. The fact that a software
verification/validation was complete should not be the determining factor
as to whether a 30 Day Notice is required.

Software Maintenance
Software Maintenance is part of the overall software development
life cycle to ensure the software is performing as intended
Software and Hardware maintenance should be considered part of
the Quality System and not require reporting
Examples of software maintenance include:
Operating system or vendor application updates/patches
Bug fixes (no new functionality)
Adding/removing users
Data archiving

Practical Considerations

Company may have only one piece of equipment in production

Software changes are often validated and implemented over the same
break (weekend, holiday) to minimize production down time
If a 30 Day Notice is required, a reasonable approach would be:
Conduct risk assessment to determine potential impact
Develop validation and implementation plan
Generate data from test environment
Submit 30 Day Notice for Review
Implement into production environment per validation plan once 30
Day approval is received

Changes Covered by Quality System

(Non-reportable)

Change Description

Rationale

1.

1.

2.
3.
4.
5.
6.

7.
8.
9.

Changing critical process parameter

setpoint(s) within a validated window.
Software and Hardware Maintenance
Equipment calibration
Software systems that control product
distribution
Update to configurable software to turn
off options/features that are not used.
Software systems that generate an
electronic Device History Record with no
added functionality.
Duplication of identical equipment for
increased capacity.
Moving equipment within a controlled
environment.
Software verifies operator is trained.

2.
3.
4.
5.
6.

7.
8.
9.

Easy to change a set point without

changing software code.
Quality System Practice
Quality System Practice
Business software system. Product is
already built.
Software was previously validated to be
configurable.
Software system documents the build
record but does not control how the
device is manufactured. Traceability
(manual or software) is a Quality System
Practice.
Standard IQ/OQ qualification
Standard IQ/OQ qualification
Training (manual or software) is a QS
practice.

Poll 1b: Do you agree that there is a level of equipment

changes that are appropriate to handle in the quality
system and would not be reportable?
94%

1. Yes
2. No

6%

Changes Appropriate for Annual Report

Change Description

Rationale

1.

1.

2.
3.

4.
5.
6.
7.
8.

Software change to remove equipment

functionality that is not used.
Software change to accommodate
products under development.
Software change to system that collects
incoming or in-process data and provides
alerts when data out of spec.
Software change to improve an operator
interface with no added automation.
Software changes when the output of the
machine/process is 100% verifiable.
Replace equipment with equivalent but
not identical equipment.
Modify equipment fixtures.
Collecting additional information/data.

2.
3.
4.
5.
6.
7.
8.

Software verification confirms that

software continues to perform as
intended.
Software verification confirms no impact
to processing of commercial products.
Operator still makes the pass/fail
decision.
No change to how device is
manufactured.
No impact to device since 100%
verifiable.
Qualification confirmed process output
did not change.
Qualification confirmed no change to
process output.
No change to how device is
manufactured or acceptance criteria.

Changes Appropriate for 30 Day Notice

Change Description

Rationale

1.

1.

2.
3.

4.

5.

Software or Hardware change to

add new functionality related to
device manufacturing.
Software change to automate the
device accept/reject activities.
Add software process control
[potential to be AR if redundant
control to scrap part earlier in
process]
Widen or shifting the operating
range beyond the validated
process range.
Replacing equipment with newer
model that has added features.

2.

3.
4.
5.

Potential to change how the

device is manufactured.
Removes operator from the
decision process. System is
making the accept/reject
decision.
Could impact the accept/reject
decision.
Requires validation of a new
range.
Requires validation of new
features.