Lachman Consultants will be exhibiting at the ISPE Annual Meeting & Expo in Atlanta from September 18-20. Please come visit us at booth 54 and pick up some of our White Papers on Cloud Computing and Data Integrity. See you in Atlanta!
An article authored by Jim Davidson, Ph.D, Vice President, recently appeared in the July-August issue of Pharmaceutical Engineering. This very timely article, “The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing”, has also been the subject of White Papers authored by LCS, as well as the topic of numerous industry symposia. Congrats to Jim […]
On June 27, 2016, FDA announced in the Federal Register the issuance of a Technical Reference Document titled “Quality Metrics Technical Conformance Guide”. This Guide is meant to supplement the FDA Guidance titled “Request for Quality Metrics” in that it provides technical recommendations for the submission of quality metrics data called for in the Guidance. […]
In April 2016, the FDA published its much-anticipated draft Guidance on Data Integrity. This Guidance is a great way for industry and FDA to start and continue the dialogue about data integrity. An interesting note about this Guidance is that buried, deep down on line 142, is a mention of “cloud infrastructure” as a “system” as it relates to “computer or related systems” in § 211.68. Up until this point, the FDA has been largely silent on the use of cloud computing for FDA regulated systems, and industry has taken this silence to be, in many ways, a prohibition to its use.
Whether we embrace it or not, the Data and Application economy is upon us. Every business is, in some respects, a digital business, and in the digital realm things change FAST. The term ‘cloud’ as a technology concept has been in use since at least 1971, but even as recently as 2009 companies like IBM […]
When most people hear of Amazon.com, they think of one of the largest online marketplaces for consumer products. What people may not realize is that Amazon is also one of the largest providers for computer power for cloud computing through their subsidiary Amazon Web Services (AWS). Running applications in the cloud is a relatively new […]
When most people hear of Amazon.com, they think of one of the largest online marketplaces for consumer products. What people may not realize is that Amazon is also one of the largest providers for computer power for cloud computing through their subsidiary Amazon Web Services (AWS). Running applications in the cloud is a relatively new […]
On 11/11/15, at the ISPE Annual Meeting in Philadelphia, Russ Wesdyk from the FDA Office of Surveillance spoke about quality metrics. Since the FDA Metrics Guidance is still in draft and the comment period is still open, he didn’t provide any specifics about the Guidance itself. Since its issuance, industry has been studying and commenting […]
