The Life Science industries are changing. The world is more remote than ever, and organizations in Life Sciences feel the increasing strain of maintaining compliance with regulatory bodies – like the FDA and ISO – while ensuring patient safety and conducting regular business.
The right FDA regulatory compliance software can help. In this modern context, that system is likely a cloud-based engineering document management system and QMS software. Meridian Cloud for Life Sciences, in particular, can help simplify compliance, streamline validation, resolve remote access challenges and more.
Here’s everything you need to know about FDA regulatory compliance software.
FDA and ISO Regulatory Compliance
Organizations in Life Sciences – and other regulated industries – must adhere to regulations established by the FDA, ISO and other regulatory bodies.
What Are the Most Important Regulations?
There are many FDA and ISO regulations that apply to regulated industries, including:
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
ISO Compliance Regulations
- ISO 9001: Quality management system for ISO 9001: 2015
- ISO 13485: Medical devices quality management system
- ISO 14001: Environmental management system
- ISO 17025: Laboratory testing and collaboration
- AS9100: Aerospace quality management
- HACCP: Food safety preventive maintenance
- IATP 16949: Automotive quality management
- SQF: Food quality management
Why Is Ongoing Compliance Important?
It’s simple: if you want to run a sustainable, revenue-driven business, compliance is non-negotiable:
- 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 by top talent.
- Maintaining compliance and achieving “continuous readiness” can decrease overall costs.
- Maintaining compliance is necessary for ongoing safety.
Unfortunately, the fact that compliance is so important doesn’t make it any easier to achieve.
What are the Challenges with Maintaining Compliance?
Many Organizations Lack Visibility into Compliance Risks
There are many organizations and regulatory agencies to consider, which makes maintaining compliance complicated and confusing. Many organizations can’t stay on top of it, and they have little visibility into where their company stands.
Real-Time Data Is Underutilized
Life Science organizations often 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.
Sites and Departments Are Siloed
In many organizations, various teams – including quality, clinical, manufacturing, regulatory and IT teams – work without collaborating with one another. This can further impact visibility.
Documentation is Not 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 can not only make it difficult to access information, but also drag out validation processes and hinder effective communication.
The right software can help.
Understanding FDA Regulatory Compliance Software
FDA regulatory compliance software can simplify compliance and risk management for organizations in Life Sciences. The most robust compliance software will be – or be part of – a comprehensive electronic quality management system (QMS) and it will be able to support compliance with requirements like 21 CFR Part 11, ISO 9001 and ISO 13485.
Cloud vs On-Premise Solutions: Which is Better?
When it comes to QMS FDA compliance software, there are both cloud and on-premise options. Historically, organizations have preferred on-premise systems, feeling that on-site systems have decreased data security and regulatory risk.
That said, modern cloud-based SaaS solutions like Meridian Cloud for Life Sciences are cheaper, faster to implement and more agile than traditional on-premise solutions. Meridian Cloud for Life Sciences can also provide impactful gains without the drawbacks by shifting the majority of the compliance burden and associated risk to Accruent.
Looking at the basics of the SaaS deployment, it includes:
- Hardware, software, infrastructure, etc.
- Environment and application management
- Automatic software updates and enhancements
- Hosted in Microsoft Azure datacenters (initially in US and the Netherlands)
- Single sign-on authentication with Office365
- SOC 1 Type II and SOC 2 Type II certification
- ISO 27001 certified data
- 24/7 ongoing training and support
Additionally, Accruent manages most aspects of the system, including:
- Technical support
- Software upgrades
- Server hardware
- OS software
- DB software
- Hosting/data center
- System monitoring
- IT Admin support
- Security audits
- Upgrade labor
This helps simplify compliance, increase uptime, and maximize the benefits of a cloud-based system without the drawbacks.
Features of FDA Regulatory Compliance Software
There are many common features that can support compliance with FDA and other regulations. These include:
When a user wants to make a change to a controlled document or submit it for review in Meridian Cloud, they initiate a controlled workflow to make that change. This forces documents to move through a defined workflow that requires users to pass through pre-defined review and approval steps. This helps maintain compliance and ensure that all boxes are checked.
Electronic signatures are required when a GMP document is put into a workflow. Each person that must provide their electronic signature will receive an email letting them know that there is a document ready for their review. As each user reviews or approves the document, their electronic signature is manifested on the PDF rendition of the document in the order they signed. This not only helps ensure that the right people see the document but also simplifies document management and streamlines the audit trail.
Electronic Print Stamp
Every time you view, modify or print a GMP document in Meridian Cloud for Life Sciences, a print stamp and watermark will be automatically generated by the system on each PDF rendering of the document to provide key timing information. This can help maintain consistency of work across time zones and help employees understand, at a glance, which document is the latest and most up-to-date version.
Along with the print stamp, users will also see a watermark across each document showing that document’s status. For both Office and CAD documents, a handy compare tool easily highlights what changes have been made between versions. In addition, when a new revision is created, the prior revision is automatically watermarked as “superseded” to ensure that only the current version is referenced.
These features provide a clear and accurate audit trail, which makes the entire auditing process easy and intuitive.
Together, this suite of features provides transformative functionality that allows for effective engineering and compliance for Life Science engineering department. It also allows Life Science organizations to make informed decisions and:
- Seamlessly connect your engineering and maintenance department stakeholders.
- Provide global and immediate access to business-critical documents.
- Ensure compliance to Change Management standards.
- Enhance efficiency by providing integrations with EAM, ERP, ECM, CAD systems, etc.
- Reduce risk and cost in data handover process between external contractors and internal stakeholders.
Meridian Cloud for Life Sciences also offers validation-as-a-service informed by Accruent Managed Services to help with:
- Project planning, protocol development, system audits, third-party review and IQ, OQ, PQ.
- Product training: The AMS team can help with initial and ongoing product training, including administration training, onsite training, advanced training, coaching and more.
- Implementation services: This includes the implementation, installation and configuration of the Meridian Cloud for Life Sciences system.
Benefits of FDA Regulatory Compliance Software
The right system can provide enterprise-wide benefits and:
- Improve quality by enabling compliance with regulations.
- Lower the cost of data collection.
- Increase data accuracy.
- Reduce regulatory errors (by eliminating mistakes like misfiling)
- Improve control over production, quality and other processes.
- Allow for more rapid search of electronics records.
- Improve information transfer between departments and between companies.
- Lower the total cost of ownership.
- Put the appropriate risk management and government procedures in place for installation, operational and performance qualification.
- Help organizations integrate both business processes and audit functions into their systems without compromising the quality of regulatory compliance.
- Optimize closed-loop quality processes, helping to streamline the investigation into any compliance concerns and streamline resolutions.
- Reduce internal and external audit risks.
- Simplify audits with FDA 21 CFR Part 820, Part 11 and ISO 13485.
Learn more about Meridian Cloud for Life Science FDA Regulatory Compliance Software.