…provided acceptable documentation demonstrating that they have developed the software for this device under an appropriate software development program; that they have performed a hazard analysis and addressed those hazards and carried out a verification, validation, and test process. These procedures provide a foundation for assuring to the extent possible that the software will operate in a manner described in the specification and in no other way…

…talent, ability, and overall knowledge …

… provided valuable insight into approaches which made sense and were easy to understand…

…support on this critical validation successfully helped [us] in complying with a Pfizer corporate initiative regarding the retrospective validation of key computer systems…

… provided valuable insight into approaches which made sense and were easy to understand…

… I consider the experience a valuable personal education in computer system validation…

… I have recommended to … management the additional utilization of [SQM’s] services as we further develop our computer systems validation program…

… guided the team through the difficult process of changing its culture to embrace a new and better way…

...Without the team’s respect for [SQM’s] knowledge and experience, undertaking this cultural change would not be possible.

…[The] leadership, dedication, and enthusiasm are evident…

…educated the software engineers and management about how to meet FDA’s requirements

… invested countless hours in the training, prodding, monitoring, tracking, and cheerleading our software engineers through the long and arduous journey from start up company software procedures to the sophisticated process now employed…

… [The] level of dedication is indicative of the relationship [SQM] has with us as a valued member of our team.

…NSI recognizes and appreciates the important contributions [SQM has] made to our PMA project.

…knowledge of both best practices in the software industry today and of the FDA guidelines was remarkable…

…helped us make rapid and lasting progress in developing and following SOPs…

…The FDA at the close-out meeting indicated [that] they were clearly impressed with the work…

…a pleasure to work with …

… can [be] trust[ed] as very knowledgeable on the software industry today and the FDA expectations with respect to software practices in the industry…

… quickly became familiar with a very confusing manufacturing situation while providing excellent response to demands from site management…

… [SQM is] an excellent addition to your staff…

… very professional, work well in a team environment

… technically capable

…displays winning attitude…

…I would not hesitate to seek [SQM’s] assistance in the future…

… the accomplishments documented in the program are truly commendable… [and] will provide Becton Dickinson … with unique competitive advantages in many markets throughout the world … (the attached program for Worldwide Software Quality Assurance … were undertaken in cooperation with our counterparts in Europe, Japan, and at Becton Dickinson … and the Research Center)

… dedication and commitment to the development of new products, as well as the manufacturing of current products…

…exercised the objectivity that is so necessary in making … appraisals.

… Certainly my job was made easier by the analytical approach and honest reporting…

Congratulations on the great job … done on the … project…