Top 8 Ways to Reach Regulatory Compliance

Companies that live in regulatory 
environments have come to 
understand that compliance is
 actually a tool that can give
 them a competitive advantage.

Many companies doing business in regulatory environments treat compliance like another obstacle to success. However, companies that live in regulatory environments have come to understand that compliance is actually a tool that can give them a competitive advantage. Statistics show that 72 percent of senior executives at regulated companies say that ensuring compliance with regulatory requirements is one of the most important challenges in their company.

Instead of kicking against regulations, smart companies embrace them and – like a judo expert – leverage their weight to find success. An organization that is more efficient in achieving and maintaining compliance can get a high quality product to market faster than its competitors.

Understand  C-level executives are on the hook to meet standards and regulations

Without having a clear understanding of what is required by law, senior level executive can find themselves in hot water. C-level executives have the specific responsibility for making sure that there is always enough resources for quality systems, and the system must be robust enough to do what it is designed to do. Executives are legally required to know what is happening at their company, where their risks are and what they are doing about them. These CEOs must prove that they are dedicating the appropriate resources for meeting the regulatory requirements.

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Ensure the entire company understands what’s at stake if standards and regulations are not met

There is a widespread misunderstanding that meeting quality standards is simply the responsibility of the quality department, but that isn’t the case. In order to ensure corporate compliance for FDA and other global regulations and standards, it is very important that every department works together to communicate the seriousness and importance of meeting regulations. Some departments may not realize there is a need for a quality management system (QMS), since they don’t necessarily deal with those responsibilities personally. Build awareness for other departments using facts and statistics. Dollar figures, hard numbers and specific information on the value of a QMS and what it can save every department is more convincing. Remind each department regularly about their part in making sure a company’s product or service is high quality and free of defects. Quality is everybody’s responsibility.

Implement a Quality Management System (QMS)

Quality and compliance systems are complex and often difficult to manage across an entire enterprise, particularly in regulated environments where strict adherence to quality standards is required. Automating such processes with a eQMS can help increase efficiencies and accelerate product delivery while maintaining FDA regulatory compliance. Replacing a paper-based QMS with an automated QMS dramatically improves a company's ability to comply with regulations and ISO quality standards, while drastically increasing manufacturing efficiency, product quality, and speed to market, at the lowest possible cost.

Document Everything

Inefficient document control and document management processes are the greatest barrier to FDA compliance for companies doing business in regulatory environments. For instance, the International Organization for Standardization’s ISO 13485:2016 guidelines state that companies need to demonstrate their quality management system is able to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. In order to do so, companies must document changes in identification numbers, descriptions of names, diagrams, process charts, technical specifications, quality plans, check lists, manufacturing specifications, standard procedures, computer files, bills of materials, assembly plans, test protocols and approved list of suppliers, to name a few. A single slip through the documentation process can cost a company everything.

Incorporate a Training Software System

Training is a critical element of regulatory compliance. The most streamlined way for companies to manage training tasks and a related compliance requirement is to provide employees with continuous training in tools and methods that promote quality improvement. A training software system is the heart of any FDA compliance process. It is a regulatory requirement that FDA / global regulatory inspectors consider critical. An automated training system reduces audit time and findings, and decreases risk of product recalls. It improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.

Be prepared for a regulatory audit

Almost all types of businesses undergo an audit, so it is critical to the success of a company to be prepared. Regular audits are necessary to comply with regulations and to ensure product safety and quality. To make it easier to ensure regulatory compliance, companies should implement an audit management software system to facilitate all audit-related tasks and activities. Without an effective audit reporting tool, managers may find it problematic to generate accurate and timely reports and trends for auditors, which could cause all kinds of issues down the road. Incorporating audit management software helps to provide analytics and reporting capabilities as well, such as customizable reports and online charting tools that enable management to receive real-time views of the audit process.

Make sure your company runs in a validated environment

FDA-regulated companies with automated quality management systems are required to provide documented evidence that their systems consistently produce results meeting compliance, a practice known as validation. Computer software validation involves a series of tests: installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). For many companies, validation is expensive and challenging because of the extensive time investment, typically several months, along with the specialized skills required. The FDA also requires companies to be in a constant state of validation, which generally means they must re-validate every time they upgrade or change their systems. To make sure they are operating in a continually validated environment, a company should implement an automated system that features Transfer Operational Qualification (TOQ). With a TOQ in play, companies are able to leverage the expertise of their software vendor to demonstrate they are working in a validated environment. TOQ provides completed validation and support documentation of IQ/OQ tests. This documentation serves as evidence that basic functions of a computer software application perform correctly as specified by the provider.

Choose a solution with robust analytics and reporting capabilities for effective management

Organizations must not only ensure product quality, but also have insight into all quality processes. Those in regulated environments, especially, need all the support they can get to see trends and understand quality issues in order to proactively solve problems. A QMS can generate a lot of valuable quality data from various groups and cross-functional teams. These types of reports, analytics and data can provide valuable insights into an organization’s quality processes – but only if the data can be collected, disseminated and reported on clearly and quickly.

This article appeared first in CIO Insight

Matthew M. Lowe is a mechanical engineer with over a dozen years of medical device experience in product development, product management, and regulatory compliance. Prior to joining MasterControl in 2006, he worked in product development and product management at Ortho Development Corp. and Bard Access Systems. He has successfully launched more than a dozen medical devices and has four patents issued. His regulatory compliance experience includes writing a 510(k) that was cleared by the FDA and managing a multisite, multiyear post-market clinical study for orthopedic devices.