Reducing the Risk, Complexity, and Cost of Compliance and Reporting in Life Sciences Companies

For life sciences companies, regulatory compliance never becomes any less complex and stringent. Depending on the exact nature of your work and where you do business, multiple regulatory frameworks apply. Existing frameworks may be refined by regulators and governments, requiring life sciences businesses to update their practices.

As a result, many life sciences companies are allocating more resources to compliance management and evolve their business roles to stay abreast of changing requirements. Smaller organizations, where staff can be easily overwhelmed by the demands of compliance, are extending their teams or adding more complex and challenging tasks to their existing compliance managers.

In some companies, compliance and regulatory functions are now defined in separation and different individuals are tasked with them. Compliance may mean remaining fully informed as regards changing requirements and frameworks, performing process and infrastructural planning, and ensuring that the company budgets appropriately to facilitate its compliance efforts. Regulatory roles translate compliance mandates into everyday processes and actual business roles, interpret them in the light of the state-of-the-art of the compliance discipline, and develop the reporting and controls to maintain and document a company’s compliance measures.

The expanding scope of compliance

Both regulatory compliance, industry practices, and the standards of individual companies are changing to encompass relationships with customers and trading partners and the management of confidential information, intellectual property, communications, and business processes in the context of these relationships. Compliance managers, for instance, need to ensure that their companies do not have any conflicts of interest with customers or partners and that they follow industry-best practices as well as compliance mandates in managing and storing sensitive data. They may need to implement specialized controls to safeguard patient or proprietary data against cybercrime. When governmental regulation demands measurably better patient outcomes, not just improvements in medications or medical product, they may need to implement additional controls throughout their processes and value chains.

In the life sciences industry, mergers and acquisitions can further complicate the compliance scenarios. Organizations inherit and need to resolve the compliance challenges of companies they acquire; doing so may become more difficult when an acquisition involved an entity in another country with a different business culture.

Easier audits and a better way to keep up with reporting requirements

When we work with life sciences clients, their top compliance-related concern often is making audits easier and less risky. To accomplish that and ensure compliance, we design their digital infrastructures in such a way that they can facilitate the reporting and implement the processes that must be in place so they can meet today’s compliance mandates. We also enhance their business foundations with the elasticity and scalability that enable them to keep their compliance practices current with changes in the business and the industry.

Out-of-the-box, NetSuite can provide many of the reports required by the SEC and other regulatory agents. We set the functionality up to be truly turnkey, ready to create and distribute accurate, timely reports. For growing companies, we often expand the reporting portfolio to include multi-country and multi-company operations without adding ambiguities or straining resources. We also help you connect compliance and financial reporting to your organization’s performance metrics by means of KPIs and dashboards that expose the outcomes and trends of your programs and projects for your specific business roles.

Workflows and roles realized in NetSuite by Sikich feature the approval mechanisms and accountability structures that can keep compliance efficient and at the core of the business. That also means role- and process-related documentation is easy to produce and present, including documentation to provide evidence that certain processes have not changed, or that changes made followed proper approvals and conformed to compliance policies.

A flexible, elastic solution—not a straitjacket

While life sciences business leaders may have different views of how roles and duties should be segregated, we use our experience from dozens of life sciences projects to help you implement the proper segregation of duties that fits your organization. And, when the company grows and you need to add programs, departments, and other business entities to your NetSuite environment, this can easily be accomplished with reimplementing the solution.

We can perform whatever NetSuite adjustments are necessary until you are comfortable reconfiguring workflows, dimensions, and business units on your own. When you need to prepare for FDA testing, which requires specific measures for control and transparency, you can take advantage of many years of practice and thousands of project hours coming together in today’s transferable Sikich expertise.

Contact us today to learn more and get in touch with the Sikich life sciences team.

This publication contains general information only and Sikich is not, by means of this publication, rendering accounting, business, financial, investment, legal, tax, or any other professional advice or services. This publication is not a substitute for such professional advice or services, nor should you use it as a basis for any decision, action or omission that may affect you or your business. Before making any decision, taking any action or omitting an action that may affect you or your business, you should consult a qualified professional advisor. In addition, this publication may contain certain content generated by an artificial intelligence (AI) language model. You acknowledge that Sikich shall not be responsible for any loss sustained by you or any person who relies on this publication.

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