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GAMP5 Software Categories | Computer Systems Validation
https://btedstone.wordpress.com/2010/02/16/gamp5-software-categories
February 16, 2010 at 10:52 pm · Filed under GAMP. 183;Tagged ASTM 2500-07. As discussed in ISPE GAMP5. The GAMP Categories for hardware and software have been retained in GAMP5, all be it in a modified format from GAMP4. The software categories identified in GAMP5 do not fit with determining the risk to product quality, efficacy or data integrity and no longer plays an integral part to determining that a computer system is fit for purpose. Category 5 Bespoke software. In GAMP3 and 4 the purpose of the GA...
Changes in validation | Computer Systems Validation
https://btedstone.wordpress.com/2008/12/21/changes-in-validation
December 21, 2008 at 2:35 pm · Filed under GAMP. There have been many changes to the approach to validation of equipment, including computerised systems over the last few years. This has culminated in the release of GAMP5. The changes in approach started with the publication of the ICH Q9. Quality Risk Management) in 2005 and adopted by the major agencies. This presented a risk based approach to quality management including validation of systems. This will include discussions on Good Engineering Practice...
FDA to Increase Inspections in 2010 | Computer Systems Validation
https://btedstone.wordpress.com/2009/08/04/fda-to-increase-inspections-in-2010
FDA to Increase Inspections in 2010. August 4, 2009 at 1:48 pm · Filed under FDA. The US Food and Drugs Administration (FDA) have been given a significant budget increase for 2010 as reported on Congresswoman Rosa DeLauro web site. Introduced by Rep. Rosa DeLauro (D-CT), the bill (H.R. 2997) provides the amount that President Obama requested for the agency, which is roughly $373 million more than the FDA’s budget for fiscal 2009 (15% increase). The full press release can be read here. 1 Comment ». You ar...
ISPE GAMP 5 | Computer Systems Validation
https://btedstone.wordpress.com/2009/07/28/ispe-gamp-5
July 28, 2009 at 3:37 pm · Filed under GAMP. 183;Tagged ASTM 2500-07. Was released in 2008 detailing Risk Based Approach to Compliant GxP Computerised Systems with the tag line Enabling Innovation and was hailed as a major advancement in the industry. This article provides a short review of the GAMP guide and the benefits to the industry. The publishing of the ASTM Standard E2500-07 in June 2007 set the scene for changes within the quality systems of pharmaceutical industry. While the ASTM standard place...
Disclaimer & Copyright | Computer Systems Validation
https://btedstone.wordpress.com/disclaimer-copyright
This blog represents the opinions of the author(s) to discuss issues that relate to the validation of automation systems within the phamaceutical and biotechnology industries. The aim of the blog is to promote discussion and prove guidance to best practices for achieving compliance status. It remains the Pharmaceutical Companies responsibility to provide a robust Quality Management System to meet applicable regulatory requirements. Images should not be copied without written permission.
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Computer Systems Validation | Validation of Automated Computer Systems
Computer Systems Validation Blog. May 17, 2010 at 7:19 am · Filed under Uncategorized. I have moved the Computer Systems Validation. CSV) to Google’s Blogger. Please follow the link for more recent posts. February 17, 2010 at 11:25 am · Filed under MHRA. Unlike the US Food and Drugs Administration (FDA) the Medicines and Healthcare products Regulatory Agency (MHRA) do not publish individual findings however they have published inspection trends. Link to MHRA Inspection Trends. 183;Tagged ASTM 2500-07.
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