Streamlining Compliance Processes with NetSuite for Life Sciences Organizations

Life sciences organizations are responsible for life-enhancing breakthroughs every day. Their high level of research and development is essential to mankind’s progress. And while their work is laudatory, it comes with many practical considerations and obstacles. For instance, these companies often struggle to comply with FDA and other governmental regulations.

NetSuite Enterprise Resource Planning (ERP) is an all-in-one cloud business management solution that streamlines compliance efforts while ensuring organizations adhere to changing mandates. By using this business management software, life sciences companies can avoid costly federal penalties for violating ever-changing government regulations and safeguard their reputations.

The most important FDA regulations for life sciences fall under Title 21 CRF and include Part 11, CRF Part 210, CRF Part 211, and Part 280.

This regulation concerns electronic signatures and electronic records. In general, Part 11 affects drug makers, biotech companies, medical device manufacturers, etc. Electronic records have long replaced physical records for most institutions, so this regulation aims to keep those records safe and ensure that electronic signatures are carefully monitored to verify authenticity.

Part 210 regulates the manufacturing, processing, packing, and holding of drugs and aims to safeguard the purity and security of pharmaceuticals.

This regulation concerns electronic signatures and electronic records. In general, Part 11 affects drug makers, biotech companies, medical device manufacturers, etc. Electronic records have long replaced physical records for most institutions, so this regulation aims to keep those records safe and ensure that electronic signatures are carefully monitored to verify authenticity.

This regulation establishes current good manufacturing practices for medical devices.

Perhaps the biggest compliance challenge is the nature of the regulations. These government standards change as the need arises and require constant vigilance from life sciences organizations to ensure compliance.

For some organizations, the company culture may be a challenge. Smaller companies, in particular, may feel that the FDA will not closely monitor their compliance efforts. That belief can be a costly fallacy.

The organization’s partners are another potential problem. A life sciences company is responsible for its partners’ compliance efforts, and ignorance of the law is not an excuse. Every life sciences organization needs to make regulatory compliance a priority.

Many life sciences organizations experience fast growth that their current technology infrastructure cannot adequately support. Some are unable to perform essential functions, such as:

• Managing different sources of organizational information
• Tracking and adding legal entities
• Scaling up manual processes
• Handling program management
• Generating accurate reports for involved companies and government agencies

The customization of NetSuite for life sciences allows the following industries to improve their compliance efforts and other essential functions.

With NetSuite for medical devices, manufacturers are able to access all their business data in one place, improve inventory and order management, and have faster and more accurate management of financials. Easy access to accurate data is one of the most important elements of compliance efforts, as is the ability to quickly adapt to regulatory changes.

These companies’ compliance efforts also benefit from inventory management, supply chain management, and integrated platforms, as well as quick adjustments to regulatory changes.

NetSuite allows these organizations to quickly adapt to new regulatory requirements, participate in mandatory audits, and adjust the operational scale.

At Green Business Systems, we offer our clients customized solutions that are simple and repeatable so that you and your staff can work with NetSuite on your own. To configure NetSuite for your life science company’s compliance requirements, contact our team of NetSuite specialists who perform system validations according to FDA regulations.

We will conduct a business process review to spot inefficiencies or redundancies that affect your organizational efficiency. We also use the power of our partners — companies such as SPS Commerce, Solupay, Celigo, Strongpoint, and others — to optimize your NetSuite for life sciences experience.

The stakes are too high for your life sciences organization to have less than optimal software. Constantly changing regulations and intense enforcement efforts mean your company can easily be caught violating regulations, leading to costly fines or the threat of imprisonment. You risk damaging your organization’s reputation and future business success if you do not take appropriate measures.

Investing in NetSuite for life sciences streamline your organizational processes by creating easy access to all data, documenting compliance efforts, and adapting to new regulations. You will benefit from sensible customization and platform integration.

For more information on how Green Business Systems can help your life sciences organization, contact us by calling 312-470-2262 or filling out our brief online form.