Hi,
In order to calculate the MKT in the warehouse, the software for the Temptell should be used. Shall this software comply with Part 11? Can I validate the software by test some necessary functions by myself?
Thank you and have a happy weekend.
Regards,
Ben
Does the software create any records that are required to fulfill any regulatory requirements? If not then Part 11 doesn’t apply. If so then you at least have to address the electronic records aspect of Part 11. If there are records that fall under Part 11, do they require signature (and that signature is executed using the software)? If so, then the electronic signature aspects of Part 11 apply.
Don’t take this the wrong way, but are you qualified to validate the system (if validation is required)? The regulation requires that personnel are qualified (education, experience, etc.) to perform assigned duties. If you are qualified, then there’s no reason you couldn’t validate the software yourself.
As far as I understand, for measuring the MKT you will be using a kind of data loggers, which will give you the RH (relative humidity) and MKT. And I believe this software will have elctronic records and electronic signatures as well, which concludes that it will be Part11 compliant.
But there are few softwares, which is having Electronic signatures but may not be implemented by the organization, as I have seen few examples in my company. So, ES implementation can be done on the basis of requirements of the department, because we may use hybrid systems too, where electronic records are linked to hand-written signatures.
Also, before qualifiying or validating any systems, you must be having a training on qualification protocols and duly signed by you.
Regards,
Sourav
Much appreciated, thanks for the great help from Yodon & Sour.
Regards,
Ben