Accessible but with plenty of useful advice and detail from the author's experience. Many guides to this kind of thing reheat the guidance but this definitely adds value.
The book is almost entirely FDA oriented, with 62304 mentioned in passing. A book that described how an integrated process can address both would have been even better in some ways.
The DVD is missing, replaced by a discrete URL on the copyright page for downloading the "accompanying software". Disappointingly, the publisher no longer maintains that link.
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