Quality Systems Integrators (QSI) will be participating and exhibiting at the Annual Meeting of the American Association of Veterinary Laboratory Diagnosticians.  Marti Turocy, of QSI, will be presenting "TMSWeb Document & Training Management" on October 8th at 4:30 pm. 

 

QSI is exhibiting at Booth # 104. Please stop by to learn more about our quality and compliance management software products.

 

www.aavld.org

 

International Conference on ISO 9000                   Rosen Plaza Hotel, Orlando, Florida

March 14-16, 2010 

                                   

For nearly two decades,  the International Conference on ISO 9000 continues to be the world's leading conference on the ISO 9000 and related standards.

 

The 2010 conference will give you the tools and knowledge to navigate in these turbulent times.  These profitable strategies  integrate international standards, management systems, core competencies, risk management, measurement systems, communication, leadership and originality.   

 

www.ISO9000conference.com 

"Quality is conformance to requirements".

 

                              by Crosby  

TMSWeb Quality Management Compliance System

 

American Management Association - Complimentary Webcasts in September!

Free AMA Webcasts

 

PharmaManufacturing.com 
- States are funding enhanced biopharmaceutical manufacturing workforce training.  See article.

State Programs Take Aim at Training

 

 

The US Food and Drug Administration Commissioner, Margaret Hamburg, has outlined her plan to improve the effectiveness and timeliness of the FDA's regulatory and enforcement system.

 

"An effective enforcement strategy depends on several key elements.  The FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible," Commissioner Hamburg said in an address before the Food and Drug Law Institute in Washington, D.C.  "We must get the word out that the FDA is on the job."

 

In her speech, the Commissioner outlined the following steps designed to improve FDA's enforcement efforts:

By taking these steps, Commissioner Hamburg said, the FDA will ensure that "violative inspection results are taken seriously, that warning letters and enforcement actions occur in a timely manner and that steps are taken to protect consumers in cases where immediate enforcement action is not possible."

 

Click here for a transcript of Commissioner Hamburg's remarks.

 

This is the second part of a 2-part article

by Janet Gough, Consultant and Author

www.gxpdocumentation.com

 

Once an electronic system has gone through the validation process and is in production, users can access it to initiate, review, and approve documents in accord with the SOPs against which they have undergone training. The validation process will have set specifications for the system based on the user requirements, so the system will be able to accommodate all the documents the system has been built to hold and to identify users by passwords linked to the user's names.  

 

The first step in creating a new document in a new system is to ascertain whether the document is actually needed. A brand new system is not searchable, so initial determination for a document needs to be based on the former system.  If a document is necessary, reviewers confirm within the new system, and the author can begin to prepare a document. Typically, system administrators make templates available to authors so that they can generate a new document.

 

To make the system fully usable and searchable for the categories of documents the system will ultimately house, legacy documents must also come into the system.  There are a few approaches for building the document repository in an electronic system.

 

Article continued.....
 

 

 About Us