Warning Letter: Failure to develop adequate written procedures (ucm442577)

Tags: Database | procedures
April 3, 2015

1. Failure to establish and maintain adequate procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). Specifically, Your procedures addressing corrective and preventive actions, “Procedures for Corrective and Preventive Action”, PCPA-00, dated10/5/10 and “Measurement and Analysis” procedure, MA-00, dated 10/5/10, are not adequate in that: a) Your procedures do not address:

1. How and how often each data source will be analyzed to identify existing and potential causes of nonconforming product.

2. Initiating a corrective and preventive action commensurate with the significance and risk of the nonconformity.

3. Verifying and validating corrective and preventive actions to ensure such action is effective and does not adversely affect the finished device.

4. Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems.

…
5. Failure to establish and maintain procedure for identification, documentation, validation or where appropriate verification, review and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, a sticky note on the “Chaps” instructions sheet stating “No Longer Need F Velcro Lengths” is the only documentation for the change to receive the elastic with the Velcro already sown onto it. This design change did not go through your formal change control as required by “Change Control” procedure, CC-00, dated 10/5/10.

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Warning Letter: Failure to validate CAPA effectiveness (ucm250065)

Tags: Database | Medical Device Manufacturer | No Procedure for CAPA
March 28, 2011

Failure to adequately verify or validate that the corrective and preventive action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). …. design changes were approved, but no validation or verification activity evaluating the effectiveness of the corrective action was performed or documented. Failure to validate an automated data processing system used as part of the quality system, as required by 21 CFR 820.70(i). For example: a. The CPRPlus database used from 2006 to the present to track AEDs and conduct audits of tracked AEDs was not validated.

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Warning Letter: Inadequate validation (ucm164129)

Tags: Biologics | Database | Design Validation Inadequate
May 14, 2009

Failure to observe, standardize, and maintain equipment and failure of equipment to perform in the manner for which it was designed so as to assure compliance with the official requirements for blood and blood components [21 CFR 606.60(a)]. Specifically, the following observations were made during review of your firm’s validation of the interface between the automated blood testing instrument [redacted] and the database system, [redacted]

• Validation sample testing and data collection was conducted on December 9, 2008, prior to approval of the validation test plan on. December 19, 2008;
• The validation pass/fail criteria was not met;
• The validation test plan was not followed; and
• The validation data was incomplete.

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Warning Letter: Database validation (ucm162745)

Tags: Computer System | Database | Design Validation Inadequate | Pharmaceutical Manufacturer
May 7, 2009

Failure to routinely calibrate, inspect, or check according to a written program designed to assure proper performance of automatic, mechanical, or electronic equipment, including computers, used in the manufacture, processing, packing and holding of a drug product. [21 CFR 211.68]

The Enterprise Resource Planning System known as the firm’s Systems Applications and Products (SAP) computer database allows rejected batches of drug product to be in Unrestricted Status (to be released for distribution).

During the inspection, you provided our FDA investigators a spreadsheet that you stated contained data for calibration of [(b)(4)], however, you were not able to provide the raw calibration data. In addition, the calibration data for the [(b)(4)] that you provided in your December response in Attachment #9 do not correspond to the [(b)(4)] observed by our FDA investigators.

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Warning Letter: MS Access and MS Excel Not Validated (g1483d)

Tags: Database | Failure to Validate Software | Medical Device Manufacturer
July 10, 2001

Your firm failed to validate several computer databases that are used for quality functions including your Access database , your [redacted] software, and your MS Excel spreadsheet program as required by 21 CFR 820.70(i).

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Warning Letter: Uncontrolled database (m4116n)

Tags: Clinical Research Organization | Database | No Audit Trail | No Procedure for Training
August 30, 2000
 
"...It is also noted in the inspection report that you do not have adequate control over the receipt of study data and its subsequent input into the database. There are no records to show when study data is received and when it is entered into the database. There is also no . No data queries or clarifications have ever been generated and sent to the sites to verify missing information or to clarify discrepancies... , Electronic Database Maintenance, are subject to 21 CFR Part 11- Electronic Records; Electronic Signatures, as well as to the record keeping regulations found in 21 CFR 812.140. A guidance document regarding this regulation, Computerized Systems Used in Clinical Trials, dated April 1999. www.fda.gov/ora/compliance ref/bimo/ffinalcct.htm"

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