Frequently Asked Questions

We work with SQL Server 2000, 2005, 2008, 2012 and 2014.

 Express, Standard or Enterprise any one of these is fine.

 All necessary Windows Updates for MS SQL Server should be current.

Default settings or as per company policies.

Default setting which is typically
SQL_Latin1_General_CP1_CI_AS

The name doesn’t matter.

Default settings which are typically
Initial Size – 5MB.
Autogrowth / Max Size – 1MB / Unlimited

Calibration cycles are often a function of a company’s instrument service operations. While recalibration is not required because of PAX-it, it is a recommended “best practice” for many organizations as part of their SOP. Calibration is usually done on a yearly basis, depending on the environment, but others recalibrate biannually or quarterly.

Audit Trail means a secure, computer generated time-stamped electronic record that allows for reconstruction of the course of events relating to the creation, modification, or deletion of an electronic record.

Yes, a workflow, such as creation of an electronic master production and control record should be validated through your computer system.

When login credentials are shared, a unique individual cannot be identified through the login and the system would thus not conform to the CGMP requirements in Parts 211 and 212.

FDA recommends that audit trails that capture changes to critical date be reviewed with each record and before final approval of the record. Audit trails subject to a regular review should include the change history of finished product test results, changes to sample run sequences, changes to sample identification, and changes to critical process parameters.