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1. Computer System Identification
The purpose of the computer system identification is to generate a list on a spreadsheet or database of
all computer systems at a particular site. This list or database will include information such as the cGMP,
system life cycle, and validation status. This list or database provides a clear and concise method of
viewing the status and information relating to all computer systems site-wide.
2. Determine cGMP Status
The cGMP status for all computer systems must be determined. This will aid in determining the level of
work necessary for each computer system. Non-cGMP systems do not have to be put through the scrutiny as
cGMP systems.
There are several questions that can be asked to help determine the cGMP status of any
computer system. Some examples include: (1) Does the system actively control or monitor a production
process that can affect the safety, identity, strength, quality, purity, or efficacy of products intended
for use in humans? (2) Does the system monitor, display, produce or record data that requires the system
operator to take a real-time procedure-controlled action that can affect the resultant product safety,
identity, strength, quality, purity, or efficacy?
3. 21 CFR Part 11 Assessment
The 21 CFR Part 11 assessment will only apply to computer systems that are identified as being cGMP
regulated and meet the criteria set forth by the FDA. Assessments are only performed for computer systems
that create, modify, maintain, archive, retrieve, or transmit any electronic record(s) that are required
to demonstrate compliance with FDA regulations. The FDA must permit the use of electronic records for this
application and the application must not be exclusively used to transmit paper records by electronic means
such as a fax sent by analog machines.
4. Remediation Plan
The remediation plan is only applicable to computer systems whose 21 CFR Part 11 assessment picked up
non-conformities. All non-conformities will be re-stated in the remediation plan along with a solution
to fix the non-conformities. A schedule for the remediation work should also be proposed within the
remediation plan.
5. Execute Remediation Plan
Once the remediation plan is approved, the schedule outlined within would be carried out. The remediation
plan contains the scope of work for all remediation activities.
6. 21 CFR Part 11 Re-Assessment
After the remediation plan has been carried out. A 21 CFR Part 11 assessment is performed again. This is
to ensure that all non-conformities noted in the initial Assessment have been fixed. This re-assessment
should pick up no further or re-existing non-conformities.
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