Validation Considerations for Mobile Devices

The rapid advent of wirelessly networked mobile devices such as tablets and cell phones into FDA regulated business processes has created significant challenges for the legacy based IT platform qualification and validation regimens. These known-state validation frameworks were defined during the prevalence of dedicated single purpose backend IT resources, coupled with traditional PC based user interfaces.

The evolution of IT infrastructures to virtual cloud processing, accessed through consumer devices controlled by highly proprietary vendor OS and application frameworks, means GxP life sciences qualification frameworks must cope with a dynamic state-less environment which challenges the very principles of the regulatory IT framework.

In the rush to adopt these technologies, many life sciences firms have implemented these mobile device interfaces without proper assessment of the impacts of their integration on existing validated applications. The result is a compliance gap where topics such as data security, authentication, functional equivalency and device management and support are questionable. A memorable recent example involved a major medical device manufacturer who incorporated iPads into their field service application. As USDM Life Sciences explored the scope of the retrospective validation, despite numerous USDM inquiries concerning the role of the iPad, it was represented by the business, QA and IT that the iPad only utilized the browser to access the web-based application, and USDM’s concerns about the need to validate the application on that platform was “duplicative”. However, upon finally obtaining a sample iPad for verification, USDM discovered that indeed there was a customized vendor native iPad application being used (in addition to the browser). This added an entire new dimension to the validation scope late in the validation project. Had this not been investigated and discovered, a major source of the application’s fundamental business data would have gone unvalidated, causing potentially negative findings on an audit.

Life sciences firms are urged to be wary of the facile explanations of vendors of the equivalence of these new mobile based platforms, browsers and custom applications to the legacy validated PC-based versions as the basis for lax qualification testing and validation of these platforms. It is essential that the following activities occur:

• Formal assessments of the impact of these devices when deployed with legacy validated applications
• Inclusion of knowledgeable business, QA and validation personnel in the process of the assessments of new device impacts
• Provision of policies and procedures for the management of these devices and their software, including change control and account management
• Careful consideration of the implication of allowing non-company owned mobile devices to access regulated applications without augmentation with Mobile Device Management tools
• Recognition that mobile browsers and custom applications mimicking legacy PC interfaces are not equivalent entities, and require qualification and validation based verifications against the requirements.

Proper due diligence up front prior to deployment can avoid nasty surprises later during the inevitable audits to follow. USDM’s expertise in rapidly and cost effectively assessing and addressing the validation challenges posed by the introduction of ground-breaking mobile devices to legacy or new GxP regulated applications can save firms time, money and embarrassment.

Track and Trace Bill Wins Approval of US Senate

The US Senate passed the Drug Quality and Security Act on November 18th. The bill now heads to President Obama’s desk, where it is expected to be signed into law soon.

If signed into law, pharmaceutical companies will have to adopt a track-and-trace system for their medicines. Individual packs of drugs would need serial numbers within four years of the bill becoming law. In 10 years, medicine would need to be traceable as it makes its way from the manufacturer to a pharmacy.

The law would also create stricter license requirements for distributors and third parties who transport drugs. The FDA would also maintain a database of wholesalers that would be available to the public through its website.

Federal track and trace requirements would replace California’s ePedigree law, which means pharmaceutical companies would have more time to comply with the new regulations.

Pharmaceutical companies need to develop a strategy to conform to the Drug Quality and Security Act, which will likely become law in the next few weeks.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet the regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made.

Read More About USDM Life Sciences Unique Device Identification/Track and Trace Services

Worried About Regulatory Compliance? Enterprise Content Management Can Help

Enterprise Content Management (ECM) is the way a business organizes and stores documents so they can be used effectively. Now, more life science companies are looking for ECM solutions as the need for regulatory compliance grows. Some companies fear legal liability associated with compliance requirements. Non-compliance could even create financial risk for your organization.

Some particular challenges for life science companies are how to use and preserve records and unstructured data. With the growing number of compliance regulations, the importance of keeping track of necessary documents is more important than ever before.

USDM Life Sciences is a global leader in ECM for life sciences.  Our ECM practice provides unparalleled knowledge and experience in all major life science ECM systems along with knowledge of the life sciences business processes and content, from IND’s to NDA, eTMF and quality. Working exclusively in the life science industry, we help our clients leverage their content management systems and achieve regulatory compliance. With our deep understanding of GxP processes and technologies, we help pharmaceutical, biotech, and medical device companies all over the world, small and large, design and implement ECM in the cloud and on premise solutions.

The Cloud Benefits Life Science Companies

A Google search for cloud computing will reveal thousands of results. The content of the results varies greatly because the Cloud means different things to different people. Some IT experts will tell you the Cloud just refers to servers that are accessed over the Internet. Others will tell you the Cloud includes anything accessed outside of your physical location via the Internet, such as many types of software. The true definition of the Cloud could be debated all day.

In the life sciences industry, the Cloud refers to server and software solutions. So, you may be asking yourself, why do I need the Cloud? There are many reasons, but here are two big ones.

Cost Savings:
Staying compliant with government regulations is expensive. One study indicates the average manufacturing company spends $2.2 million a year on compliance. Many life science companies spend well above the average because they face more regulations than most businesses. Human cost is the largest share of compliance spending. The life sciences industry is already slated to face even more government regulations in the coming years. The Cloud offers automated solutions that require less manpower.

Always in Compliance:
The life science industry is in an era of vast regulation change. To make matters more complicated, every country is creating their own specific rules that international companies have to follow. The fines for non-compliance can be devastating to a business. The Cloud makes it possible for companies to automatically make compliance changes as soon as new regulations go into effect.

Many businesses end up spending millions of dollars on a huge workforce and hope they’ll be able to keep up with regulation changes in order to stay compliant. Some companies are trying to migrate to the Cloud but don’t know where to start.

USDM Life Sciences helps life science companies find the right Cloud technology for your life science business and the right strategy to migrate to the Cloud. Ultimately, implementing systems in the Cloud means your company will be save money on IT costs and always be in compliance with government regulations.   To read more about the benefits of clouding computing for life science companies, visit our Life Sciences Cloud practice page.

Medical Device Companies Preparing for New FDA Regulations

On September 20, 2013, the FDA announced a final rule for the Unique Device Identification (UDI) system.

A UDI is a unique identifier for each medical device sold in the United States. The UDI along with information on the device’s components must be registered in a global database, known as the Global Unique Device Identification Database (GUDID).

The ruling means that labels and packages of class III medical devices, such as pacemakers and heart valves, conform to new UDI rules by September 24, 2014. Deadlines for class II and I devices occur progressively over the next seven years.

The FDA believes the UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help identify product problems more quickly, better target recalls and improve patient safety.

“UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health in a press release recently issued by the FDA.

USDM is helping some of the world’s most well recognized medical device companies prepare for the new UDI regulations.