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Where are you now? Intelligence Services > Validation > Related Warning Letters > Software Validation

Software Validation Related Warning Letters

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PDF PDF file (392 KB)
St. Gobain Ceramiques Avancees Desmarquest, 2002-04-26
"You need to property validate the xxx furnace process. Please supply a complete proposed validation protocol for the xxx furnace. This protocol should specifically address if any aspect of this furnace is computer controlled and how the software will be validated."

PDF PDF file (192 KB)
Sysmex Corporation, 2002-01-22
"There were no procedures for review of source codes in design controls for software validation, and there is no assurance that all lines and possibilities in the source codes are executed at least once."

PDF PDF file (518 KB)
Medical Device Services, Inc., 2001-12-13
"Failure to validate computer software for its intended use according to an established protocol prior to approval and issuance, and document the results of these validation activities, as required by 21 CFR 820.70(i). For example: a. The associated computer hardware and software used to identify incoming devices. b. Software used to control the production and assignment of work orders and the control of master SOPS. c. The software and hardware used to print labeling."

PDF PDF file (273 KB)
Sorenson Development, Inc., 2001-10-17
"Revalidation of the microprocessor software used in the Palm Pump has not been completely performed following an engineering change in April 2001. Additionally, computer and/or automated data processing system software used in production and quality systems, including the use of electronic signatures, has not been validated."

PDF PDF file (441 KB)
Luneau S. A., 2001-10-12
"Your firm's xxxxx is computer-controlled. It uses software programs to record data from measurements of the radius of curvature and corneal refraction of the eye. However, your firm has not validated the software and computer system used to record this data for its intended uses. Your firm has no documentation to assure that they perform as intended. Also, there is no validation and documentation of subsequent changes to the software."

PDF PDF file (305 KB)
Cleveland Med. Dev., Inc., 2001-09-17
"No documented corrective and preventative action for software bugs found during retrospective validation. Validation testing revealed several responses that were unexpected and may potentially adversely effect the performance of the Model 15 Crystal-EEG telemetry device. Yet these responses were not evaluated and addressed. These unexpected responses include the software acceptance of a new patient under an existing patients identifier without displaying an error message and four other unexpected responses documented in the Crystal Software Validation document."

PDF PDF file (305 KB)
B. Braun Medical, Inc., 2001-09-17
"Failure to validate computer software used to (1) control the EtO sterilization process, for example xxxxx cycles, and (2) control the xxxxx employed in the manufacture of disposable IV sets, to ensure the software will perform for its intended use. 21 CFR 820.70(i)."

PDF PDF file (346 KB)
EP MedSystems, 2001-07-10
"Your firm failed to validate several computer databases that are used for quality functions including your Access database, your xxxxx software, and your MS Excel spreadsheet program as required by 21 CFR 820.70(i)."

PDF PDF file (454 KB)
Cardiomedics, Inc., 2001-04-13
"No procedures for the development of software used to control devices. The software used for the operation of the CardiAssist CounterPulsation system was not properly validated. Problems with this software have been identified and corrective measures have been undertaken to replace this software version."

PDF PDF file (338 KB)
Allergy Laboratories of Ohio, Inc., 2001-01-23
"Manual verification of calculations and inventory tracking with the existing computer software that has been found to be problematic is not an adequate reason for lack of validation. Existing computer software should be validated or replaced."

PDF PDF file (619 KB)
Pharmacia Corporation, 2001-01-11
"The software validation documentation failed to adequately define, update and control significant elements customized to configure the system for the specific needs of the operations. The system design documentation has not been maintained or updated throughout the life of the xxxxx software dating back to 1985 despite significant changes and modification that have taken place. These include program code, functional/structural design, diagams, specifications, and text description of other programs that interface with xxxxx."

PDF PDF file (472 KB)
Spolana a.s., 2000-10-30
"You indicate that you will develop a complex software validation schedule in cooperation with the software vendor by December 31. However, this validation schedule will not be approved by Spolana until January 31, 2001 and the software validation exercise will not be completed until June 30, 2001."

PDF PDF file (235 KB)
Harper Hospital, 2000-04-13
"Failure to perform/maintain computer validation [21 CFR 21 1.68] in that: there was no documentation to show if the validation was reviewed prior to software implementation."

PDF PDF file (142 KB)
Sabratek Corporation, 1998-08-19
"Failure to ensure that changes to specifications, processes or procedures are verified or where appropriate validated, before implementation. For example, there was no documentation of the verification or validation that the change to the software was effective."

PDF PDF file (216 KB)
AccuMed Inc., 1998-06-09
"Your Waters HPLC hardware and software system used for assay testing of products in the laboratory has not been qualified or validated."
  "There are also no written procedures for the security of data files, password control, access levels, and functions, or preventative maintenance."

PDF PDF file (236 KB)
Anabolic, Inc., 1998-03-13
"Your computer software used for tracking raw material, finished product quarantine/release, and archiving master formulas has not been validated."

PDF PDF file (255 KB)
Invacare Corporation, 1997-08-20
"Your firm's response to FDA 483 is inadequate because no documentation of the software validation was provided or available to the investigator for his review, nor is it provided in the response. We do not believe there was any miscommunication, since the investigator requested to see the software documentation used to program the chip for controlling the device and none was available according to your firm's Quality Manager (QM)."

PDF PDF file (511 KB)
Rhone-Poulenc, Inc., 1997-01-07
"Validation of the APAP computerized process control system is incomplete in that specific critical functions have not been tested or validated. In addition, your computer validation protocol is deficient in that it does not address change control and/or software maintenance and does not provide for a back up system or schedule nor specify who has authority to access specific programs or make software changes."

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