Rob Duncombe

1
Validation of Computer Systems.

• Rob Duncombe
• Pharmacy Operations Manager
• Broomfield Hospital.

2
Validation of Computer Systems

• I could bore you senseless - but hopefully I
  wont.
• The Views of Suppliers
• A simple Example
• Some Conclusions.

3
The Views of Suppliers

• Credit to -
• ASCribe
• Cerner
• Clinisys

4
Q1. Do Users of your systems need to Validate
them?

• At Installation. - Yes
• New Versions - Yes
• New Releases - Yes

5
Q2. Do You Supply Validation Protocols?

• NO. - Although will give help, advice and
  recommendations.

6
Q3. How do you validate your software.?

• Very detailed specifications in place for new
  versions and releases. Separate teams work on
  validation to the programmers.
• Work to ISO 9000 / 9001.
• USA - FDA standards. - Systems Medical Devices.

7
Q4. Complaints.

• Due to not using the software properly
• Not understanding the software
• Not installing it correctly
• A Valid complaint?

8
Q5. Do Users have the necessary Validation Skills.

• Generally No.
• Different clinical groups - different views on
  validation.

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Q5. What Skills are Required.

• Clear understanding of what the software does
• Sufficient training in its use
• Access to QA Services
• Access to previous validation results
• Can not teach validation - Experience only
  gained by Experience.

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Further Skills.

• Planning
• Organisation
• IT Support
• The successful validations are those that have
  the right balance. Clinical Technical.
• Technology Prima Donna.

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The Technology Prima Donna

• Good employees are hard to find, but good
  employees who understand technology are even
  rarer. If you have any technical skill at all -
  or you can fake it - take full advantage of the
  raw power and happiness that comes with being a
  technology Prima Donna

12
Q6. The possibility of harm due to lack of
validation?

• YES

13
GOS Operating System.
PN Prescribed
Baxa File Created
PN Formulated
File Acted Upon
Transfer of file
File received
Bag is Made
Training
Sterile Particulates
Commissioning
Accurately
Revalidation
Precisely
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GOS Validation Approach

• Same nomenclature as GAMP
• Reference to GAMP throughout
• Same structure as VMP sample in GAMP
• - IQ
• - OQ
• - PQ
• Finally - Validation Report.

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The Conclusions

• Validation is absolutely critical
• If we do not validate properly then patients will
  be harmed
• Adopt a structured approach to validation
• We have some of the key skills required for
  system validation
• If the mood takes us become technology prima
  donnas.

16
The Technology Prima Donna

• Have a Bad personality
• Anyone who asks a question is a moron - The
  people who dont ask questions are morons too.
• Never respond to questions.
• Dress like a blind tramp
• Yell without provocation
• Be mysterious and eccentric
• Complain a lot.