Hi all,
I have a following question: We are a accredited calibration service provider (17025 certified), we use internally developed software to produce calibration certificates for our customers.
As calibration records are GxP records for our customers, calibration certificates are GxP records, so our internal system hosting the data used to produce the certificate must be validated.
1. Is Calibration certificate a raw data? Or data used to produce the certificate is raw data which needs to be retained? What is expected from us by the regulated customers in regard to record retention?
2. As this is not COTS software does it fall under GAMP cat. 5 software and require the expanded validation effort? My concern is that as this is an internal SW, we have the opportunity and also need to be able to deploy new versions like patches and bug fixes asap. After major releases we had times where we installed new SW patches weekly, or sometimes even twice a week. We must ensure that SW Validation and mainly IQ will not slow this down or increase effort/costs.
Many thanks for sharing your thoughts on this topic.
I have a following question: We are a accredited calibration service provider (17025 certified), we use internally developed software to produce calibration certificates for our customers.
As calibration records are GxP records for our customers, calibration certificates are GxP records, so our internal system hosting the data used to produce the certificate must be validated.
1. Is Calibration certificate a raw data? Or data used to produce the certificate is raw data which needs to be retained? What is expected from us by the regulated customers in regard to record retention?
2. As this is not COTS software does it fall under GAMP cat. 5 software and require the expanded validation effort? My concern is that as this is an internal SW, we have the opportunity and also need to be able to deploy new versions like patches and bug fixes asap. After major releases we had times where we installed new SW patches weekly, or sometimes even twice a week. We must ensure that SW Validation and mainly IQ will not slow this down or increase effort/costs.
Many thanks for sharing your thoughts on this topic.