1. Balancing and conforming with existing
standards whilst designing innovative products
BALANCE
Regulation and Engineering
Jasmin NUHIC
Senior Manager, Manufacturing Engineering
Medtronic, Inc
February, 2013

2. Changing Minds
MEDTEC ¦ Stuttgart, 2013 2

3. Topics
• Regulation
• Engineering
• Balance
• Example
• References
• Discussion
MEDTEC ¦ Stuttgart, 2013 3

4. Regulation
• Timeline
• Elements
– General
– Scope
– Electronic records
– Electronic signatures
– Audit trails
• Enforcement
MEDTEC ¦ Stuttgart, 2013 4

5. Regulation (cont`d)
• Target areas
• Common audit
findings
• Common pitfalls
"All Part 11 systems must be validated;
• Benefits of being yet not all validated systems must be Part
11 compliant"
compliant
• Training
MS Word «Track Changes» is 21 CFR Part 11 compliant?
MEDTEC ¦ Stuttgart, 2013 5

6. Engineering
• Mechanical (equipment) eng.
• Manufacturing eng.
• Industrial eng.
• Software eng.
• Process eng.
• Quality eng.
• R&D eng.
• ...... eng.
MEDTEC ¦ Stuttgart, 2013 6

7. Balance
SUCCESS
• Euipment
• Process (control)
• Quality (control)
Y
• Documentation O
U
• Supply chain
REGULATIONS ENGINEERING
• Customer feedback
• Supporting activities COMMITMENT
MEDTEC ¦ Stuttgart, 2013 7

8. Example
• DANTRON CNC machine
with CMM built in
• Equipment, Process,
Quality – all in one
• Automated and combined
to save time, space and
energy
• Engineering balancing SAMPLE IMAGE, courtesy of Dantron Technology
http://www.datron.de/uk/products/machine-
tools/milling-machines/m8cube-milling-machine.html
regulation
MEDTEC ¦ Stuttgart, 2013 8

9. References
• FDA Website
– www.fda.gov/ora/compliance_ref/part11
• International Society for Pharmaceutical
Engineering (ISPE)
– GAMP5, A Risk-Based Approach to Compliant GxP
Computerized Systems
• John Murray
– Software and Compliance Specialist with FDA (Part
11 Subject Matter Expert and advisor)
MEDTEC ¦ Stuttgart, 2013 9

10. Discussion
THANK YOU!
MEDTEC ¦ Stuttgart, 2013 10