With the influx of computer technology applications in the pharmaceutical industry,
increasing attention has been given to validation of these systems. This paper describes the …

Documented evidence for the purported performance of a computer system or program is a
requirement for pharmaceutical research laboratories. Most models for computer validation …

At the Pharmaceutical Manufacturers Association (PMA) Seminar on Computer Systems
Validation held in January 1984, the Food and Drug Administration (FDA) emphasized that …

Pharmaceutical industry regulatory compliance of computerized systems is of ever
increasing importance. The regulations require specific record keeping on product safety …

In the biopharmaceutical industry, validation requirements have significant implications in
almost every engineering aspect of the production process. Strict demands from the US …

This column discusses topics and issues associated with computer validation in order to
provide a useful resource for daily work applications. It provides information regarding …

A Parenteral Drug Association (PDA) Committee on Software Validation was formed about
three years ago to address some of the issues associated with validating automated …

For those who have learned the “what” and “why” of computer system validation, this paper
will concentrate on the next step—“how” to validate a computer system. The following topics …

Enterprise systems now cover a wide range of applications in the pharmaceutical industry.
Common systems are MRP II applications such as SAP R/3 or BPCS, laboratory control …

Computer validation should address the scientific correctness of the application software,
the business objectives of the organisation, and the concerns of regulatory agencies. It is a …