Nobody wants to be audited

Posted on July 18, 2012

Just hearing the word "audit" is enough to cause any executive to cringe, especially in industries heavily regulated by government agencies. The process of a regulatory audit is time consuming, disruptive to regular workflow, and can lead to serious penalties if the results are unsatisfactory, all of which can boil down to significant financial loss. Unfortunately, audits are hurdles that must constantly be cleared in order to prove compliance. The good news is that proper preparation can help streamline the process and reduce the amount and severity of, or even eliminate, costly issues being brought to light during an audit.

So, what is the best way to prepare for regulatory audits? Ask this question of most people, and you will get some form of answer that runs along the lines of, "Do a good job," or in the more knowledgeable cases, "have standardized operations and quality records." One would hope that the first is being done anyway; the second is getting...

Electronic Document Management Systems

Posted on June 13, 2012

Over the past few years we have seen FDA warning letters in relation to non-compliant Electronic Document Management Systems (EDMS). Of particular concern seems to be the use of "off the shelf" software such as Sharepoint. EDMS are becoming increasingly popular because they automate many of the document processes that used to be done by hand. However, configuring and validating a new document management system can be an extremely challenging task, not to mention very expensive. Because of this, many firms are currently using unvalidated document management systems. Below is an excerpt from an FDA warning letter sent to an undisclosed firm:

"Off-the-shelf software (Microsoft SharePoint) is being used by your firm to manage your quality system documents for document control and approval. However, your firm has failed to adequately validate this software to ensure that it meets your needs and intended uses. Specifically. at the time of this inspection there were...

Event Summary - IVT CSV Week

Posted on May 08, 2012

Last month, Globiox had the pleasure of attending IVT’s 13th Annual Computer System Validation week in San Diego, CA. We had a great experience at the conference and had some great conversations with some of the leading minds in the industry.

The highlight of the conference was a Globiox-led presentation titled Cloud Computing and IaaS, PaaS, and SaaS – What are the Necessary Processes and Steps. The presentation was delivered by Globiox’s own Leo Perskii and featured two other presenters: Globiox president Patricia Rossman and Ron Hinkel, Director of Quality Systems at BioReliance. Participants were provided with a brief overview of cloud computing technologies, and the discussion continued on to examining considerations when determining whether or not cloud computing makes sense for Life Sciences organizations, what those organizations should look for when deciding on a cloud computing provider, and finally the conversation focused on how...

Innovation in Validation – The time has come

Posted on March 12, 2012

One of the buzzwords in the pharmaceutical industry today is Innovation. I heard an industry leader at a conference last week say that the reason the US Pharma industry is struggling is because of MONEY. That is, historically the US Pharma industry has had TOO MUCH MONEY and has not had to innovate.

Well, we are experiencing the pain of lack of innovation now. We are building plants outside of the US and outsourcing overseas because we have not innovated and made our processes more efficient and productive, so we are forced to cut costs in these most drastic ways.

We are doing our small part at Globiox to cut costs of producing high quality drugs and medical devices by innovating within our areas of expertise. One area in which we are innovating is validation. We would like to have input from the validation community about areas in which you believe validation costs too much and takes too long. We will do our best to fix it!