Why Regulatory Compliance, R&D Management and Quality Management have to be unified

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For highly regulated industries such as life sciences, it is critical to follow and maintain quality control and quality management processes as the regulatory environment for the life sciences sector is robust, complicated, and continually changing. Because of the intricate and time-consuming processes involved in quality management and compliance, consistently delivering quality products has become increasingly challenging.

According to current good manufacturing principles (cGMP), Quality Control and Assurance must be integrated into all processes, from research and development to production. Failure to comply with compliance rules may result in severe fines or penalties depending on the type of infringement. The FDA has recently issued increasing warnings for non-compliance with cGMP for quality, including warnings for inadequate documentation and poor standard operating procedures (SOPs). One study shows that since 2000, the pharmaceutical industry has been hit with almost $50 billion in fines for infractions of compliance-related laws.

Therefore, it’s crucial to incorporate compliance management into product lifecycle management systems since it enables companies to develop products faster and market them more successfully. A Quality Management System (QMS) solution can provide biotech companies with a comprehensive framework to comply with cGMP throughout the product lifecycle, supported by accurate record-keeping and processes that adhere to operational requirements.

In the past few years, many startups have emerged in the SaaS-based compliance industry to assist companies in managing their ongoing compliance responsibilities and risks. SecureFrame, Vanta, Drata, Sprinto, and Laika are some of the market players streamlining compliance workflows covering some of the most well-known compliance standards, including HIPPA, SOC 2, ISO 27001, and PCI DSS. The increasing demand for regulatory control solutions is anticipated to boost the global SaaS-based compliance market to $17.5 billion in 2027.

Contrary to most businesses focusing on security compliance alone, Orcanos Ltd. offers integrated design control with Quality Management Systems (QMS), including regulatory compliance. The company ensures the product lifecycle runs smoothly from the start while also assisting companies in developing operational excellence capabilities. Its software platform shortens product development time by combining tools for application lifecycle management (ALM), quality management systems, risk management, document control, and a customer service center into a customizable package. With the help of a process-automation tool, Orcanos’ platform enables the preparation of CE-mark applications, FDA submissions, and audit preparedness.

Orcanos, founded in 2005, has a long history of innovation and experience in highly regulated, high-tech industries. By working with some of the largest organizations in the world, such as GE Healthcare, which employs and depends on Orcanos to reduce compliance negligence costs significantly, the company has gained traction and developed into a prominent player in the SaaS-based enterprise compliance management market. Orcanos’ other partners include Argo Medical, Medset, Zimmer MedizinSysteme, and Mazor Robotics.

Life Sciences companies are under immense pressure to meet changing regulatory requirements, launch products, manage costs, and maintain documents. With management systems that combine compliance management, ALM, and quality control, companies can develop products that comply with regulatory requirements and meet consumer standards faster with fewer costs. Given how tech innovation is transforming industries, SaaS-based compliance software for companies in highly regulated industries is a significant breakthrough. Partnering with a tech company that offers effective solutions to navigate quality control and compliance hurdles could go a long way in helping biotech companies achieve desired operational results efficiently and cost-effectively.

Originally Published by VentureBlock Contributing Editor Jonathan Walker on Tech Bullion. Republished with Permission.

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