Keeping up with the FDA

Posted on December 11, 2012

Quite a few companies in FDA regulated industries are experiencing "Dynamic Shock." After handling their operations and quality assurance in the same manner for years, they are suddenly faced with severe findings on a 483, or are even issued a warning letter. Dynamic Shock stems from the constantly shifting nature of the industry and the practical policy changes the FDA makes, with the goal of constant industry improvement. These changes often take the form of industry guidances, which reflect the FDA's current mindset about various aspects of certain industries. Some guidances receive large amounts of attention in the media and are difficult to overlook. Others however, are less publicized and are missed by some companies, resulting in negative findings during an FDA site visit.

The FDA does make serious efforts to ensure that regulatory information is readily available to the public. contains a vast wealth of literature, including industry...

Validating the Cloud

Posted on November 14, 2012

As a sales guy, I am often speaking to Life Science professionals about the challenges they face. The subject that keeps coming up of late is the Cloud. There seems to be a lot of confusion, concerns and excitement about the possibilities that the Cloud presents for regulated industries. Our resident expert Leo Perskii received high praise when he presented on this very topic recently in San Diego. This 4 part series is now available and this month we are excited to share it with you.

Part 1: Leo explains the characteristics of Cloud Computing.  It’s a brief rundown of what the Cloud is and why the regulated industry should care.

Part 2: What should you consider when deciding if the Cloud is right for your company? This video is a great place to start.

Part 3: Once you have decided that the Cloud will work for you then how do you decide who to engage as your provider? There are questions you need to ask and things to consider.

Part 4 Cloud Computing Issues and Their Influence on Validation

Posted on November 14, 2012

Part 1     Part  2     Part 3

Part 3 What to Know Before Engaging a Cloud Provider

Posted on November 14, 2012

Part 1     Part 2     Part 4

Part 2 Considering Whether to Use Cloud Computing

Posted on November 14, 2012

Part 1     Part 3     Part 4

Part 1   Characteristics of Cloud Computing

Posted on November 14, 2012

Part 2     Part 3     Part 4

Warning letters, what they are, how we can help

Posted on October 09, 2012

As discussed in our previous post, "FDA 483: your company contains critical errors," a company whose operations are not compliant with the regulations set out by the Federal Food, Drug, and Cosmetic Act and related acts (The Act) is likely to face serious consequences from the FDA. Although there are exceptions in the case of serious violations, a Warning Letter is generally issued by the FDA following an extensive review of site inspection results, usually within 30 days of the inspection close out. The purpose of a Warning Letter is to notify companies that they are operating in violation of The Act, and that they are expected to remedy all outstanding issues in order to become compliant. The significance of a Warning Letter versus a 483 is that a Warning Letter is an official statement by the FDA confirming that a company is operating out of compliance, whereas a 483 is an inspector’s (highly influential) opinion on the matter, but is not an official Agency...

FDA 483: Does your business contain critical errors?

Posted on August 22, 2012

In the aftermath of an FDA site inspection resulting in unsatisfactory findings, the company in question faces a difficult situation that must be addressed quickly to avoid serious consequences. If not properly addressed, negative observations made during an FDA visit can ultimately result in suspended operations, bad press, scrupulous monitoring of operations, recall of products, and warning letters. Fortunately, the process followed by the FDA is intended to allow most companies operating out of compliance to remediate their practices and continue operation in an acceptable manner. Although the remediation process tends to be hectic and unpleasant, it can actually be beneficial for a company because if done correctly, the remediation will result in higher quality business practices.

At the conclusion of an FDA site visit, the inspectors will issue an FDA Form 483 if there are observations. A 483 lists detailed observations of any issues the inspectors consider...

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...