This paper considers the selection and adoption of automated, digital capture colony counters within the pharmaceutical microbiology laboratory. The focus is on how such devices can be qualified (or validated) and how data integrity concerns can be addressed.
Fungi in pharmaceutical processing environments can originate from air, water, personnel and the material introduced into different facilities where products are manufactured. Over the years, several fungal issues associated with pharmaceutical cleanrooms, cold rooms and controlled areas have been reported.
This article discusses some of the changes and clarifications that have been made to the document. There are separate sections identified corresponding to the sections in the Annex .
In the waterfall approach developers are sometimes not aware of the challenges when designing the software which may require changing the design instead of continuing the software development process which is allowed in the Agile approach.
Process validation begins with determining risk, not only in the manufacturing process but also in the design and use of the device. Risk assessment and management is the logical foundation of engineering, especially in the medical device industry, and it is required by regulatory bodies.