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Labcompliance News, January 2003

Jan 29, 2002

Warning Letter for Insufficient Testing of Networked Data Systems

Networked data systems (NDS) should be used according to design specifications, They should be tested not only under normal conditions but also under critical conditions such as high load. A laboratory received a warning letter because they had five data acquisition systems connected to an NDS although it was designed for up to four. An other citation was that validation of the system did not include critical system tests such as volume, stress, performance, boundary, and compatibility(W-067). Labcompliance user club members can pre-study keywords and extracts and download warning letters. To preview extracts and ordering users club membership, click here and select W-067

Jan 22, 2002

FDA Representative Reports on Problems with Legacy Systems

During the annual meeting of the International Society of Pharmaceutical and Medical Device Professionals Tom Arista, an FDA investigator and national expert in biotechnology presented an inside view on legacy systems. Topics have been: recent trends in validation of legacy systems, common problems encountered and methodology for validating legacy systems. Highlight of the presentation was a list of 10 most common problems.

  • The quality unit is unaware of problems
  • An unknown number of individuals have access to the computer control/monitoring systems, with unknown levels of access, and access performed by outside firms
    No written procedure in place to describe the controls for computer control/monitoring system remote access
  • Validation master plan fails to take older pieces into account
    Alarm activity tests fail to take into consideration the monitoring devices#'s calibration tolerance
  • System alarm records are not retained, nor are there documents that alarms were reviewed and followed with necessary corrective actions
  • No alarm checks for computer control monitoring systems for temperature, and relative humidity
  • Lack of, or incomplete data to support the validation
    Support utilities and equipment not validated or re-qualified following changes or modifications
  • No system description, e.g., as built/installation diagrams etc

The FDA also expects analytical systems to be validated now, no matter whether they are new or old. More than a year ago, a firm in Europe received a warning letter despite of the fact that there was a plan in place to validate all systems within about six months. "This is not acceptable", was one of many citations in the warning letter.

Labcompliance user club members can download the warning letter (ref W-036). To preview keywords, extracts and ordering users club membership, click here and select W-036.

Jan 21, 2002

FDA Warning Letters for Incomplete Structural Validation, Non-validated Compilers and Incomplete Laboratory Records

Functional AND structural testing is important for software validation during development. A device manufacturer did receive a warning letter because structural testing was incomplete and compilers have not been validated at all (W-065). An other warning letter did go to a a pharmaceutical laboratory for incomplete records of laboratory test data. Other deviations have bee inadequate number of qualified people, missing batch production and control records, and inadequate stability program (W-066). Labcompliance user club members can pre-study keywords and download warning letters. To preview extracts and ordering users club membership, click here and select W-065 and W-066

Jan 16, 2002

FDA Released Final Guidance: General Principles of Software Validation

This 43 page document supersedes the draft document, "General Principles of Software Validation, Version 1.1, dated June 9, 1997. The guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices.

Jan 2, 2002

Gamp 4 for Validation of Automated Systems Released

GAMP 4, the GAMP Guide for Validation of Automated Systems, has been released in December in Amsterdam. The guide aims to assist companies in the healthcare industries to achieve validated and compliant automated systems. It provides guidance to the suppliers of those automated systems on their development and maintenance by following good practice, and assists the suppliers in producing the necessary documentation required to support validation.
GAMP 4 is a significant advance on previous versions of this widely accepted guidance on validation of automated systems. The complete document has been revisited and refined to reflect current regulatory expectations and good practice. It has been considerably enhanced and restructured, following principles and recommendations defined by the GAMP Industry Board
To order GAMP 4, please visit www.ispe.org

Jan 3, 2002

Warning Letter for Non-compliant E-Drawings

Documents that are required by a predicate rule and generated by a computer must comply with FDA's e-signature/records rule 21 CFR part 11. A device manufacturer did receive a warning letter because the computer system used for device drawings documentation was not validated and failed to comply with other part 11 requirements such as limited system access, being able to make accurate and complete copies, and protecting records to enable their accurate and ready retrieval. An other deviation was missing validation and documentation of subsequent changes to the software (W-064). Labcompliance user club members can pre-study keywords and extracts and download warning letters. To preview extracts and ordering users club membership, click here and select W-064