Excel Spreadsheet Validation for FDA 21 CFR Part 11

Given the ease of their operations; spreadsheets find wide acceptance in a number of activities for laboratories. These include analysis, data capturing and reporting. Since these activities are part of a regulatory framework; companies using these spreadsheets need to comply with guidelines. These guidelines are set out in FDA 21 CFR Part 11, which deals […]

The role of Good Documentation Practices on Compliance Activities

The role of Good Documentation Practices on Compliance Activities. An acceptable definition of Good Documentation Practices (GDP) would be the prescribed standards by which documentation is created and maintained in the pharmaceutical industry. The FDA has set some GDP standards, but these are not the only GDP standards. There are others that come under the […]

Contamination control plan

A contamination control plan is one of the essential practices of cGMP.  Having it in place is a prerequisite for a validated facility, because lack or absence of it is one of the primary reasons for the issuance of 483’s. Among these, the FDA cites lack of sterility assurance as the most important factor for […]

The Device Master Record (DMR)

The Device Master Record (DMR) The Device Master Record (DMR) is what may be described as the complete documentation required in the manufacture of medical devices that meet quality standards. The DMR, along with the Device History Record (DHR), is an extremely important element of the Quality System Regulation (QSR) in relation to FDA cGMP. […]