Lack of Audits Critical at Software Company

Inspectors from the FDA’s Florida district office found a pattern of missing or faulty records of supplier audits at a Clearwater, Fla.-based Soft Computer Consultants, leading to an eight-observation Form 483 for the company. The company also received a Warning Letter from the FDA.

The form, which followed a Jan. 5 to 15 inspection, cites the firm for not conducting technical audits of some outside suppliers in 2012, 2013 or 2014. Paperwork on multiple supplier audits was apparently forged or faulty, as the employee listed as the auditor said he didn’t perform them, and the audit reports were not reviewed for as much as 18 months after the fact, the 483 says.

Internal documents didn’t properly explain how to conduct audits, and employees were not trained on the proper procedure, the form adds.

The 483 also cites the software firm for not properly analyzing or trending complaint data. No trend analyses had been generated for 2013 or 2014, while the analysis for 2012 was generated during the inspection.

In addition, the company’s procedures for handling software coding defects didn’t always include investigating the causes of all product nonconformities or identifying corrective actions. For example, Soft Computer didn’t analyze whether an interface problem in one type of software that had not been detected by in-house testing might be repeated in other software that also had not been fully tested.

The company also failed to make testing for this problem mandatory for all new software. And software changes associated with the fix weren’t verified or validated via Soft Computer’s design change procedures, including corrections made by outside contractors. The investigator also noted problems with design review and design input related to the same software fix.

Finally, while the field correction related to the interface problem was initiated on Nov. 26, 2014, it had not been completed by the time of the audit, the form states.

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