Maintaining ongoing compliance is one of the biggest challenges for organizations in Life Sciences, particularly as the industry faces challenges like:
- Heightened transparency expectations, and
- Increased emphasis on innovated technology.
What’s more, the latest regulations and expectations are constantly shifting, forcing companies to re-examine their fragmented approach to compliance and re-evaluate where they stand. Here are the key regulations and updates that you should know about to develop a more integrated, universal understanding of compliance in Life Sciences.
FDA Compliance Regulations
The Food and Drug Administration regulation (also known as “FDA”, “USFDA”, “Healthcare Regulatory Compliance”) was introduced by the USA Food and Drug Administration. FDA applies to all companies that work with food, cosmetics, tobacco products, medical devices, drugs, animal and veterinary, vaccines, biological products and radiation emitting products.
The most important FDA regulations for Life Sciences fall under the Title 21 CFR Umbrella.
The U.S Food and Drug Administration (FDA), the Office on National Drug Control Policy (ONDCP) and the Drug Enforcement Agency (DEA) all use Title 21 Code of Federal Relations (CFR) to govern food, drugs, cosmetics and other public health products. When it comes to enforcement, inspections can be conducted for the purpose of pre-qualification, routine inspection, or “for-cause” to investigate a specific problem reported to the FDA – so you need to be consistently ready.
Important Title 21 regulations include:
- FDA 21 CFR Part 11: Electronic records and electronic signatures
- FDA 21 CFR Part 211: Drug and pharmaceutical manufacturing
- FDA 21 CFR Part 820: Medical device manufacturing and distribution
You can learn more about these regulations here.
ISO Compliance Regulations
The International Organization for Standardization, or ISO, is an independent, non-governmental regulatory body. It establishes standards that are meant to ensure that the products, systems and services are produced in a high-quality environment designed to ensure safety and efficacy.
ISO certifications are not currently required for Life Science organizations in the U.S. That said, if you’re going to market outside the U.S., these standards do apply -- and maintaining ISO compliance can:
- Grant your business access to a worldwide market,
- Help you lower costs, and
- Increase customer confidence in the safety and reliability of your products.
You’ll need to pay close attention to these ISO standards:
ISO 9001: Quality management system for ISO 9001: 2015 and ISO 13485: Medical devices quality management system
We are grouping these two standards together because they are related – and many organizations in Life Sciences choose between ISO 13485 compliance and ISO 9001 compliance. Both standards aim to help ensure that companies create safe, high-quality products. That said, ISO 13485 focuses more on the safety and efficacy of medical devices, while ISO 9001 focuses on customer satisfaction. Currently, ISO 13485 is more widely adopted as a standard, and it is widely seen as the first step in complying with EU regulations around medical devices.
ISO 14001: Environmental management system
ISO 14001 is a standard that lays out rules for enacting, maintaining and improving an environmental management system. The goal? To make sure that companies are being responsible when extracting, manufacturing, using and disposing of raw materials. This can reduce pollution and environmental degradation.
ISO 17025: Laboratory testing and collaboration
ISO 17025 sets requirements for ensuring that your processes are high quality and lead to accurate and precise readings. ISO 17015 is also a standard for training of people taking measurements. For medical testing laboratories, the language is changed slightly in ISO 15189.
ISO 14971: Risk Management for Medical Devices
ISO 14971 has been widely adopted by the medical device industry to help control risks and monitor the effectiveness of controls throughout the lifecycle of a medical device.
ISO 31000: Risk Management
ISO 31000 represents and internationally recognized benchmark for risk management processes, and it, “provides principles, a framework and a process for managing risk.”
The right document management tool can help simplify your compliance with these and other regulations. Learn more.