Berlex Drug Quality Control Software

WARN 12/03/96 Berlex

Appropriate controls are not exercised over the [purged text] Software, used by Quality Control and Technical Services, to assure that changes in laboratory control records are instituted only by authorized personnel.

There are no written procedures defining the appropriate use for the abort, terminate, suspend, restart, and stop functions which are accessible to all analysts. Also, the terminate and suspend functions were not evaluated during validation.

There are no requirements for analysts to document or notify the supervisor when these functions are used. There is no documentation indicating that analysts were trained in the appropriate use of these commands.

This system does not have the ability to maintain an audit trail.

A backup file of data entered into the computer should be maintained except where data, such as calculations are eliminated by the computer. Hard copy or alternative systems designed to assure that data is exact and complete and that it is secure from alteration, inadvertent erasures, or loss shall be maintained. Instruction that analysts not use the terminate and suspend commands does eliminate the need to evaluate the effect these commands have on data acquisition. In addition, without an audit trail to check the use of these functions how is your firm assured that appropriate control has been exercised? Your SOP [purged text] does not define the level of authority needed to execute these commands.

Security measures have not been instituted to prevent unauthorized access to the [purged word] system used in the Quality Control and Technical Services Laboratory for Fludara raw material and finished product testing. Your firm did not perform software validation prior to initiation of product testing in 5/92. This system was not evaluated for installation, operation, or performance qualification prior to use at the Wayne facility.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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