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Timestamp: 2013-06-20 08:31:04
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Post: learning management system and Part 11 compliance (Topic#4327)
02-06-10 06:39 PM - Post#5642 Hi,
Our company is a medical device manufacturing company. We just bought an application to manage training of employees. This application stores training records and has the ability for employee to sign for certain training.
Training record is a quality record according to CFR820. Hence, I believe when we use this application to generate and store records in lieu of paper record, we need to comply with Part 11.
However, our case is a little complicated, which I don't know how to solve.
We have different types of training: classroom, external and self study.
1. Classroom is where we apply for a training. An external trainer will come to our company and deliver the training. We only sign the attendance record. At the end of the training, this attendance record will be submitted to the learning manager. She will then log into the application and sign all of our records saying that we have completed the training. However, the signature is not shown on the report.
2. External training is where we go to an offsite training. After the training, we receive the trainiing certificate.
3. Self study is where we have to read all procedures that we require to know. We will do this by ourself and then we will log into the application, put in our password to sign off the training. This signature will be shown on the report.
I don't think what we are doing complies with Part 11 -e-signature requirement. What do you think we should do instead?
Please help. Previous
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