Regulatory Compliance Solutions Blog

Top Mistakes in SaaS Implementation

Wednesday February 19, 2014

Before you begin a software as a service (SaaS) transition, you may want to consider some of the commonly made mistakes by companies that are implementing a SaaS application. SaaS is useful, versatile and scalable, but it’s still a different type of technology that needs to be approached in a unique way.

What Is 21 CFR Part 11?

Tuesday February 4, 2014

21 CFR is a title within the Code of Federal Regulations. Title 21 is reserved for the rules of the United States Food and Drug Administration (FDA).

Capgemini and VMware Cloud Orchestration Partnership

Friday January 24, 2014

Software companies Capgemini and VMware have announced that they are extending a strategic partnership that will allow them to develop various solutions aimed at making both the management and provisioning of cloud based deployments easier than ever before.

Microsoft Dynamics for Mobile Apps

Thursday December 12, 2013

Considering that an estimated 91 percent of all adults own cell phones, and 61 percent of these cell phone owners have smartphones, it is safe to say that many people depend on their phones to help them stay connected. This is even more true for professionals in sales and related industries.

Microsoft Dynamics Reveals Upgrades

Thursday November 21, 2013

Microsoft recently hosted the Microsoft Dynamics CRM Global Premiere Event in Barcelona, Spain. The event saw over 70,000 attendees. The event showcased several new changes and upgrades to Microsoft Dynamics, with the goal of empowering businesses so they can serve their customers better and increase their customer bases while serving current customers to the best level possible.

The FDA and Mobile Medical Apps – Who’s Regulated? Who’s Not?

Thursday November 14, 2013

With almost 100,000 health related mobile apps (free and fee based) available from popular app stores, patient-consumers have access to information about monitoring vital signs, tracking exercise and caloric intake, and information about drug interaction and contraindications.

FDA Regulation Slows the Surge of Medical Apps for Mobile Devices

Thursday November 7, 2013

New rules and regulations will now be requiring the makers of many medical apps to receive FDA approval before offering them to the public. Any medical app that in effect turns a smartphone into a medical diagnosis tool will now be subject to FDA clearance.

New Concerns about SaaS (Software as a Service) and Cloud Security

Friday November 1, 2013

The security of SaaS applications on cloud platforms has become a major concern for many companies. Both SaaS applications and cloud platforms have unique security risks, and using both of them in conjunction can open up a business’s network to security breaches. To counter these breaches, companies need to understand the basics about how these systems work and why they are vulnerable to intrusion.

What FDA Tracking Requirements Mean to Medical Apps

Thursday October 24, 2013

Like contaminated food, malfunctioning medical equipment poses a major threat to human health. Due to the risk that improperly-working medical instruments potentially pose to society, the FDA’s Modernization Act (FDAMA) regulates distribution of these devices. To obtain FDA approval, tracking codes are required for some types of medical products, which allow for easier notification and product recall if necessary.

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.