Regulatory Compliance Solutions Blog

The FDA Approval Process Suffers Slowdown Due to Government Shutdown

Wednesday October 16, 2013

On October 1, 2013 the Congress of the United States failed to pass a budget or continuing resolution to fund the government’s ongoing routine operations. As a result, the government furloughed 800,000 employees and stopped or curtailed most government programs. As a result, many unanticipated federal activities ceased or are cut back. For instance, the Food and Drug Administration (FDA) has stopped all food inspections. Other FDA activities have also been temporarily stopped or curtailed. According to the FDA, the effects of the shutdown are far reaching. Following are the major effects of the shutdown.

How to Select a Validation Company

Monday August 19, 2013

Selecting a third party company to perform validation and software testing can significantly reduce costs while increasing software quality, compared to leveraging internal resources. Having a third party company perform testing allows an organization to redirect its employees toward projects that can positively impact bottom line revenue.

A Supplier’s Guide to Servicing a Life Sciences Company

Monday August 5, 2013

Pharmaceutical, medical device and biotechnology companies rely on vendors to fulfill numerous business critical needs. Whether it is a product, service or IT solution, successful vendors all have a critical component in common: they must anticipate the regulatory risk life sciences companies face and adapt proactively.

Analytics: Quality Assurance’s Best Friend

Tuesday July 16, 2013

The concept of analytics has been a buzz worthy topic for the past decade, and for good reason. Analytics harvests data and information that is being produced by routine business transactions and transforms it into usable information.

What does the FDA have to say about Validation?

Tuesday July 2, 2013

The FDA has outlined the requirement that all life sciences companies validate (Good Manufacturing Practices (GMP)) systems and processes. While the regulatory requirement is apparent, the FDA has been silent on publishing specific methodologies for achieving compliance. The FDA allows companies to develop and justify their approach to systems validation as long as the software intended uses are properly documented and tested.

What Needs to be Validated?

Tuesday June 18, 2013

The term validation has a very specific and stringent definition as far as pharmaceutical, medical device and biotech companies are concerned. At a high-level, the concept of validation ensures a system is operating as intended. More specific to life sciences companies, validation is a structured process to satisfy a regulatory requirement.

The Proprietary Software Validation Dilemma

Tuesday June 4, 2013

When it comes to software validation, there is a presumption that home-grown software cannot be validated externally. Organizations tend to operate under the assumption that only those who develop and work with their proprietary software will have the ability to understand its core requirements and intended use. As a result, the validation effort is directed internally, placing a burden on business users.