The FDA issued a March 17 warning letter to software developer Agile Radiological Technologies because the firm's Radiation Analyzer (RAy) Film Dosimetry software does not meet good manufacturing practices (GMP) standards and deviates from quality system (QS) regulations, the agency said.
The firm failed to identify software errors as a data source "for identifying existing potential quality problems" and also did not document the failure investigation, according to the agency. In addition, Agile failed to implement, document, verify or validate the corrective action.
Design controls were found to be sorely lacking, according to the letter. Specifically, Agile did not have complete procedures in place to control the device design to ensure specified design requirements were met. The firm's design control procedures did not ensure all design input requirements were identified, and no mechanism was included for addressing incomplete, ambiguous and conflicting requirements, the letter said.
Agile also failed to "document, validate or where appropriate certify, review and approve design changes," the FDA wrote.
Specifically, the firm released four version updates since the release of the RAy software in 2003, but the firm "did not document the development, verification/validation, and review/approval of these changes," the agency said.
Further, Agile also did not establish and maintain a design history file for each type of device that contains or references the records necessary to demonstrate that the design was developed according to approved design plans, the letter states.
Production and process controls were also deemed inadequate by the FDA because the firm failed to validate software used as part of the quality system.
Management controls were also found to be lacking because Agile management did not establish and implement an effective quality system. Specifically, the QS procedures for corrective and preventive action and design change control were incomplete, and formal management reviews of the quality system effectively were not conducted. Training procedures for personnel were also not established, the letter said.
Finally, the firm did not establish adequate procedures for conducting quality audits and had not even conducted an audit, the letter states. In fact, the firm did not even have written procedures stating which areas would be audited and how deficiencies would be corrected.
Agile did not return calls requesting comment by deadline. To view the warning letter, visit http://www.fda.gov/foi/warning_letters/g5783d.htm (http://www.fda.gov/foi/warning_letters/g5783d.htm). ()a href="http://www.fdanews.com/ddl/33_15/" target=_blank>