Many industries fall under the ‘Life Sciences’ umbrella: biotechnology, pharmaceuticals, healthcare technologies, biomedical devices, environmental sciences – the list goes on. And all these organizations have two things in common: first, as life science companies, they’re dedicated to researching and improving organism life. Second, they all have to deal with a lot of red tape and federal regulations to remain operational.
The second point is not glamorous, but it’s important – and compliance is becoming increasingly complex as factors like globalization, heightened transparency expectations, increased emphasis on innovation, and ever-evolving customer needs make regulations that much more complicated (and important).
In this context, many organizations are now finding their approach to compliance to be woefully lacking, and it can be hobbling their chance at ongoing success. After all, the more adeptly organizations can understand and adhere to the regulations that apply to them, the more effectively they can lower costs, streamline operations and focus on do their jobs, (i.e., making lives better).
Here’s everything you need to know about FDA regulations and how to simplify FDA compliance for organizations in life sciences.
FDA and CFR Regulations for Life Sciences: The Basics
The most important FDA regulations for organizations in the Life Science industries fall under the Title 21 CFR umbrella.
What Are the Most Important FDA Regulations for Life Sciences?
Title 21 CFR: The Umbrella of FDA Compliance
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.
Title 21 CFR, Part 11
Title 21 CFR Part 11, in particular, is all about electronic signatures, electronic records, and ensuring that both components are trustworthy, reliable and equivalent to paper records (ERES). Generally speaking, part 11 applies to medical device manufacturers, drug makers, biotech companies, and other FDA-regulated industries.
This focus on electronic records may seem oddly specific, but establishing a trustworthy, consistent electronic paper trail is a major time-saver and necessary for maintaining record standards in a modern age. Before part 11 was established in 1997, institutions had to submit physical documents to be audited, and it cost a lot of time, physical space and efficiency. Part 11 makes it much easier to prove compliance and to comply with other regulatory sections.
That said, it’s still difficult to get right. Having electronic signatures and records that are up to regulatory standards requires audits, system validations, electronic signature software, and systems that can help store, organize, and process the electronic data that must be maintained.
Title 21 CFR: cGMP System
Similarly, cGMP, or Current Good Manufacturing Practice, is a system enforced by the FDA to ensure that products are consistently produced and controlled according to quality standards. CGMPs assure proper design, monitoring and control of manufacturing processes and facilities.
You will see specific cGMP regulations for various product categories in Title 21 CFR, including:
- 21 CFR Part 210. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs.
- 21 CFR Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals.
- CFR 21 Part 211 Subpart C and D: Buildings and Facilities and Equipment
- 21 CFR Part 820. Current Good Manufacturing Practice for Medical Devices
This isn’t technically a regulation, but it’s important to mention in this context. GAMP®, or Good Automated Manufacturing Practice, is defined as a system for producing quality equipment using the concept of prospective validation following a life cycle model. In simpler terms, GAMP is a set of guidelines – for both users and manufacturers of pharmaceutical products – that helps pharmaceutical organizations understand how they should validate their computer systems to remain compliant with ever-changing FDA regulations.
GAMP is not a regulation in and of itself, but most pharmaceutical companies that want their automated systems to meet the FDA quality standards adopt GAMP principles and procedures to do so. The latest GAMP standard, GAMP-5, is the most structured and project-based approach to GAMP. It revolves around four tenets:
- GAMP-5 helps users interpret regulatory requirements as they relate to the manufacturing of computerized pharmaceutical products.
- Second, it establishes a common language and terms that help systematize production.
- Third, it ensures a system life cycle approach that covers all phases of production.
- Finally, GAMP establishes the roles and responsibilities of each involved person all the way back to suppliers.
It’s a lot of moving parts – and FDA compliance is only one piece of a complex puzzle of regulations that organizations in life sciences must adhere to – but it’s important to get right.
Why Is Mastering Compliance So Important?
It’s simple: if you want to run a sustainable, revenue-driven business, compliance is non-negotiable:
- Compliance mistakes are too costly to ignore: Compliance failures are costly – and remediation costs, non-compliance fines and reputational damage can add up before you know it.
- Companies with mature compliance capabilities are heavily favored: Many companies with mature compliance functions are recruiting top talent to hone their compliance skills. Those with an established compliance culture will not only attract top talent but also develop an ethical, industry-leading reputation.
- Maintaining compliance can decrease overall costs: ‘Continuous readiness’ compliance models are much more effective than ‘mobilize-prepare-host-remediate-disband' operating models when it comes to lowering overall compliance costs.
- Maintaining compliance is necessary for ongoing safety.
Unfortunately, the fact that compliance is so important doesn’t make it any easier to achieve.
Common Roadblocks to FDA Compliance in Life Sciences
Life Science Organizations Lack Enterprise-Wide Visibility into Compliance Risk
With so many governments and agencies in the ring, compliance itself is a complicated and wild ecosystem – and many life science organizations don’t have a comprehensive understanding of the landscape or where their organization stands.
Real-Time Data Isn’t Utilized as It Should Be
Usually, life science companies tend to use historical data for compliance – but real-time data and analytics could help organizations more effectively identify and address incoming risks.
There’s Little Regulation Around New Tech
Many companies are doing everything they can to deliver new technologies that address unmet patient needs. That said, there’s a lot of confusion when it comes to new tech and compliance, and companies often have poor communication with regulators. Translation? Major compliance complications down the road.
Departments are Siloed
In many organizations, various teams – including quality, clinical, manufacturing, regulatory and IT teams – work without collaborating with one another.
Important Documentation Isn’t Available and Centralized
Most organizations don’t have a centralized repository of compliance resources that their employees can consult – and this is a huge misstep. What’s more, important documentation to obtain compliance and meet audit requirements isn’t usually widely available or comprehensive, making it difficult for regulated companies to show proof of compliance when regulators arrive.
Organizations are Behind on Their Digital Transformations
Oftentimes, organizations are operating using a patchwork of modern and legacy systems and processes. This:
- Makes it difficult to access up to date, as-built engineering information.
- Leads to more time spent on system qualification, validation and audits.
- Leads to low visibility and poor communication.
It’s also becoming explicitly frowned upon by the FDA, which is starting to expect automation in compliance — particularly with things like electronic medical-device reporting (eMDR) and electronic common technical document (eCTD).
How the Right Tech Can Simplify Compliance Efforts
The right technological ecosystem, culture and business structure can address many of these concerns and simplify compliance, helping you support your team, facilitate effective processes and turn your compliance policies from a cost into a sustainable competitive advantage (even when a new product launches or a new business relationship is explored).
This, according to Deloitte, requires that organizations:
- Obtain continuous readiness for regulatory inspections.
- Develop integrate a single, enterprise-wide view of compliance risk.
- Diversify their talent pipeline to strengthen compliance skills.
- Engage regulators as part of the innovation model.
- Build data analytics capability to predict key risks.
- Share compliance expertise to mitigate lack of local compliance resources.
These points, in turn, require a well-connected, robust and user-friendly technological ecosystem.
The right computerized maintenance management system software (CMMS), for example, can strengthen data integrity and help significantly with the FDA validation process (while leading to improved efficiencies, decreased downtime, elevated employee satisfaction and higher ROI).
Similarly, a robust cloud-based electronic document management system can:
- Facilitate continuous compliance and continuous readiness for inspections.
- Enable digital transformation and, in turn, a comprehensive view of compliance risk.
- Lead to faster system qualification and validation.
- Allow for easy sharing of documentation and important compliance expertise.