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Computer Systems Validation for the Pharmaceutical and Medical Device Industries,

Richard Chamberlain, 0963148907, 9780963148902, Alaren Press, 1994


This book presents the topic of computer systems validation in a regulated environment in a
manner that the layman can understand. It explains the relationship of validation to the
implementation of computer systems. A step-by-step plan for implementing validation procedures
in almost any environment is given. The chapters cover preparing validation protocols, writing &
implementing Standard Operating Procedures, testing systems, managing files, preparing
documentation, conducting audits & inspections, & operating in a validated environment. One of
the appendices to the book includes 16 draft Standard Operating Procedures. The book comes with
two floppy disks (3.5 & 5.25 inch) each containing the draft Standard Operating Procedures & the
forms introduced in the book in both ASCII & WordPerfect formats. The book is essential for
management, quality assurance, scientists, & information management personnel in both of these
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