Labcompliance News, October 2007

October 8, 2007

FDA Continues to Reinforce Electronic Audit Trail

"Electronic audit trail not reviewed" and "Electronic and audit trail does not truly identify the responsible individuals who made the change" have been cited as deviations in a recent 483 inspectional observation. So the firm had electronic audit trail but it was not implemented right to demonstrate and document data integrity and people accountability. The FDA inspection team also noted that "The system does not automatically time-out. If an employee fails to log off a computer and walks away other individuals can easily access the computer under the first employees account". Labcompliance will conduct an audio seminar with clear recommendations on how to comply with FDA's expectations for system functionality and procedures for implementation  The 483 observation can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (W-187).

October 20, 2007

New Book Edition: Validation and Qualification in Analytical Laboratories

Authored by Dr. Ludwig Huber, this Second Edition of the Interpharm Bestseller discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. This title serves as a complete source to the subject, and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process. It also provides guidance on risk assessment, qualification of certified standards, handling out-of specification situations, validation for Part11 compliance, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.
For more information and ordering, click here

October 29, 2007

New Computer System Validation Tutorial

The new Computer System Validation should help to to get a good understanding on FDA requirements and strategies for implementing computer validation projects.  The tutorial includes

• A primer with basic information and recommendations for implementation from planning to the validation report.
• Expert advice on selected topics
• Links to warning letters, 483's and/or establishment inspection reports
• Literature references
• Links to other websites

October 29, 2007

40+ Validation Templates and Examples and  from Labcompliance 

Labcompliance now offers 40+ templates and examples for validation and compliance for regulated industry. Such templates and examples ensure consistent and efficient implementation and can increase confidence for inspections. They are available in PDF format or in Microsoft word with hyperlinks for easy customization. For a list with titles and ordering, click here.