Regulatory compliance is when businesses follow state, federal and international laws, or regulations relevant to operations. No matter the size of the company, all businesses must follow certain laws and regulations as part of the operation. It involves observing rules set by the Occupational Safety and Health Administration (OSHA) to ensure a safe work environment for employees or the guidelines of the Equal Employment Opportunity Commission (EEOC) to ensure discrimination-free hiring practices for example.
The specific requirements can vary depending on the industry and type of business. Regulatory compliance differs from other aspects of corporate compliance (such as following internal policies and rules).
To make it clearer, regulatory compliance involves following external legal mandates set by the state-federal or international government, while corporate compliance involves following internal requirements set by the management. However, both help drive accountability in the workplace.
Many companies treat compliance like an obstacle; however, it has been proven that meeting regulatory compliance is a tool to a competitive advantage. An organization that is more efficient in achieving and maintaining compliance can get high-quality products faster than its competitors.
How to Meet Regulatory Compliance and Standards?
First, you should note that meeting quality standards isn’t only the job of the quality department, but to ensure corporate compliance for FDA and other global regulations and standards, it is more than important to include every department. They should all work together and communicate the importance of meeting regulations.
7 Steps to Follow
1- Implement a Quality Management System
Quality and compliance are often difficult to manage particularly in regulated environments, where strict adherence to quality is required. Automating such processes with an eQMS helps increase efficiency and accelerate product delivery while maintaining regulatory compliance.
Replacing a paper-based QMS with an automated system improves a company’s ability to comply with regulations and ISO quality standards while increasing manufacturing efficiency, product quality, and speed to market, with the lowest cost possible.
2- Document Everything
Lacking document control and management processes can be a great barrier to FDA compliance. The ISO 13485 guidelines state that companies need to demonstrate that their quality management system can provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
To do so, companies must document all changes in numbers, diagrams, charts, specifications, plans, checklists, specifications, standard procedures, computer files, etc. Any minor slip through the documentation process can cost your company everything.
3- Incorporate a Training Software System
Training is a crucial element of regulatory compliance. The simplest way for companies to promote quality improvement is by providing continuous training on tasks and tools related to quality.
FDA and regulatory inspectors consider training as a critical regulatory requirement. An automated training system reduces audit time and findings and decreases the risk of product recalls. It improves product quality safety, increases customer satisfaction, and ensures FDA and ISO compliance.
4- Be Prepared for Regulatory Audit
Your company should be ready for audits, it is critical for its success. You should note that audits are necessary to comply with regulations and ensure product safety and quality. To make audit easier, you should implement an audit management software system, that facilitates all audit-related tasks and activities.
Having an effective audit tool will make it easier for managers to generate accurate and timely reports and trends for auditors. Incorporating audit management software helps provide analytics and reporting capabilities, such as customizable reports and online charting tools that enable management to receive real-time views of the audit process.
5- Run in a Validated Environment
FDA-regulated companies with automated quality management systems, are asked to provide documented evidence that their system produces compliant results. This practice is known as validation, which involves a series of tests, such as installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
However, validation is expensive and challenging for many companies because of the extensive time investment and specialized skills required. Moreover, the FDA requires companies to be in a constant state of validation. This means they should constantly re-validate every time they upgrade or change their system. To do so, companies need to implement an automated system that features Transfer Operational Qualification (TOQ). A TOQ allows companies to leverage the expertise of their software vendor, to prove they are working in a validated environment.
In addition, TOQ provides complete validation and support documentation of IQ/OQ tests. This serves as evidence that the basic functions of computer software applications perform correctly.
6- Compliance Officer
The role of a corporate compliance officer CCO is gaining prominence in many businesses. The CCO serves as the point person that champions corporate integrity, accountability, and ethics. His main focus is to stay on top of the constantly evolving regulatory landscape and make the necessary compliance decisions.
7- Establish and maintain your policies and procedures
It is not enough to have policies and procedures; they need to address the specific compliance areas identified in the audit. They also need to be reviewed regularly to stay current with the laws-changing regulatory landscape. And that is why it is important to designate a CCO.
In addition, policy management requires the need to track when employees have read and signed your policies. If you can prove that employees have read and acknowledged the policy, this will decrease your company’s liability.
These steps will help you create an effective regulatory compliance program in your business that protects your resources, reputation, and internal and external audience.
Now that you have learned about the ways to meet regulatory compliance and standards, learn about promoting a culture of quality with ISO Standards.