Perceptive Informatics launches RECIST web site
Perceptive Informatics (Boston) reported the launch of a web site designed to help investigators apply the new 1.1 version of RECIST (Response Evaluation Criteria In Solid Tumors) in medical imaging-based oncology trials. Perceptive Informatics, which participated in the RECIST Working Group, has incorporated into its RECIST web site at www.recist.com, a comparison between RECIST 1.0 and 1.1, as well as instructions on how to effectively use the new criteria. Perceptive Informatics, a subsidiary of Parexel, is an eClinical solutions provider.
Software firm cited for Part 11 lapses
The May 11 warning letter to R4 (Strongsville, Ohio) contained a laundry list of deviations from the quality systems regulations (QSRs) that suggested either a lack of familiarity with the QSR or a failure to document it's compliance activities, a task which itself is required.
The company, which writes software for ultrasound equipment used to monitor perinatal vital signs, was cited for lack of quality systems in broad terms, but FDA also alleged that "no employees in your firm are familiar with the requirements" of Part 820 "and no one has received training" for QSR requirements.
As might be expected, the list of omissions includes lack of design history files, lack of change controls, lack of complaint handling procedures, and lack of procedures for medical device reports. Ironically, the software firm also was cited for Part 11 lapses, including an electronic documentation system that purportedly lacked audit trails, system access limitations and electronic signatures.