Quick Answer
Regulated industries constantly face pressure from multiple compliance frameworks, such as federal agencies and European Union regulatory bodies. These government regulations encompass a range of requirements, including FDA electronic records standards, quality management standards, product safety regulations, and data security mandates. Propel addresses these challenges through a unified platform that combines quality management, electronic signature validation, product compliance tracking, security certifications, and audit trails into a single system.
This approach dramatically reduces compliance burden, eliminates data silos, and ensures complete traceability across all regulatory requirements—delivering both risk reduction and operational efficiency that separate point solutions cannot match.
What Is Regulatory Compliance and Why a Unified Platform Approach Matters
Companies in healthcare, life sciences, medical devices, aerospace, financial services, and other regulated sectors traditionally manage compliance through fragmented systems: one tool for quality management, another for document control, a third for training records, and yet another for product specifications. This siloed approach creates significant compliance risks and compliance issues across business operations.
Research from McKinsey demonstrates that implementing native, automated compliance can reduce operational costs by more than 70% while improving control effectiveness.
The business case for native compliance is clear, but understanding how a unified platform addresses specific compliance regulations and examples of regulatory compliance is essential for compliance officers and stakeholders.
Seven Layers of Regulatory Compliance
1. Quality Management System (QMS) Compliance
At the foundation of regulated operations sits the Quality Management System. Companies must document and track quality processes with rigorous reviews and approvals to meet ISO 9001 and ISO 13485 standards—the latter specifically designed for medical device manufacturers and focused on regulatory compliance, risk management, and traceability.
Propel QMS manages the critical quality processes that regulators and government agencies expect:
- CAPAs (Corrective and Preventive Actions) – Systematic problem-solving with root cause analysis
- SCARs (Supplier Corrective Action Requests) – Vendor quality management and accountability for service providers
- Complaints and Defects – Customer issue tracking and resolution
- Affected Items tracking – Ensuring all products related to quality issues are identified and addressed
This ensures necessary data is documented and applicable reviews and approvals are completed according to ISO 9001:2015 quality management principles, which emphasize process approach, risk-based thinking, and continual improvement across business processes.
2. Electronic Records & Signatures (FDA 21 CFR Part 11)
For life sciences and medical device companies, compliance with FDA 21 CFR Part 11 is non-negotiable. This regulation establishes the criteria under which electronic records and signatures are considered trustworthy, reliable, and equivalent to paper records.
Propel supports these stringent record-keeping and retention requirements by ensuring electronic records and signatures are:
- Trustworthy and reliable – Meeting the same evidentiary standards as paper documentation
- Uniquely identifying individuals with clear accountability
- Maintaining integrity of signed records through tamper-evident controls
- Comprehensive audit trails for workflow, training, document, and item records with detailed history of approvals and signatures
The FDA's guidance emphasizes that Part 11 controls should be applied based on the predicate rules (the underlying regulatory requirements) and the impact on record integrity. Propel's validation package includes User and Functional Requirements, Risk Assessments, Test Plans, IQ/OQ/PQ protocols, and Validation Reports—providing the documented evidence regulators expect during inspections and supporting a comprehensive compliance program.
3. Product Compliance Tracking (Regulatory Specifications)
Global markets demand adherence to an ever-expanding web of product safety and environmental regulations. Propel helps manage compliance status through Specifications and Declarations for:
- RoHS (Restriction of Hazardous Substances) – The EU's Directive 2011/65/EU restricts hazardous substances in electrical and electronic equipment, requiring conformity assessment and technical documentation.
- REACH – The European Commission's regulation requires registration, evaluation, and authorization of chemicals, with specific obligations to communicate Substances of Very High Concern (SVHC) throughout the supply chain.
- UL Standards
- FDA regulations
- ISO standards
- China RoHS and other global requirements
Companies define compliance requirements in Specifications, then declare compliance status through a controlled change workflow in Declarations, ensuring proper review and approval with full traceability. This approach addresses the complex product compliance landscape where a single component change can trigger cascading compliance reviews across multiple regulations, reducing the risk of non-compliance and potential sanctions.
4. Data Security & Infrastructure Compliance
Beyond product and process compliance, regulated industries must demonstrate their technology infrastructure meets rigorous cybersecurity and quality standards. This is critical for protecting personal data, health information (under HIPAA requirements), and preventing data breach incidents. Propel meets multiple frameworks simultaneously:
- ISO 9001 & 13485 – Quality management system requirements supporting organizational certification and corporate governance
- ISO 27001 – Information security management standards for data storage and protection (inherited from the Salesforce platform foundation)
- SOC 2 Type II – Independent examination of controls relevant to security, availability, processing integrity, confidentiality, and privacy based on the AICPA's Trust Services Criteria
- Government Cloud Certifications – FedRAMP High authorization for systems processing high-impact data where loss could have severe or catastrophic effects on operations, assets, or individuals
- Other regulations may include NIST frameworks for security controls and risk management, GDPR (General Data Protection Regulation) compliance for organizations handling EU citizen data, and more.
These certifications aren't merely checkboxes—they represent ongoing commitments to control effectiveness, continuous monitoring, and independent verification. For government contractors and public sector organizations, FedRAMP compliance is mandatory and demonstrates the comprehensive security controls necessary for handling sensitive federal information.
5. Audit Trail & Traceability
Regulatory inspections hinge on one critical question: Can you prove your processes work as documented? Complete traceability provides that proof.
Throughout the system, Propel maintains comprehensive audit trails tracking in real-time:
- All changes to records and data with before/after values
- User actions with precise timestamps
- Approvals and electronic signatures
- Document access and modifications
This complete traceability is essential for regulatory audits and demonstrates compliance with process controls. When an inspector asks, "Show me who approved this change and when," the answer is immediate and irrefutable. McKinsey research shows that digital risk and compliance platforms can deliver 10-20% productivity gains and potentially reduce compliance losses and fines by 10% through better analytics and automation. This approach to regulatory compliance management ensures that compliance officers can respond quickly to audit requests.
6. Training Compliance
Regulatory agencies require documented evidence that personnel are qualified for their roles. Propel’s Training Records module allows companies to:
- Set and maintain role-based training plans
- Create training quizzes to verify comprehension
- Manage and document training records with proper retention periods
- Ensure personnel qualifications meet regulatory requirements before performing critical tasks
Training compliance ties directly to quality outcomes—untrained personnel represent a controllable risk that regulators expect to be systematically managed as part of a robust compliance program.
7. Backups & Disaster Recovery
Propel includes built-in replication for automated data backup and disaster recovery. This protects against data loss and ensures business continuity, critical requirements for regulated industries where records must be retained for years or decades. The ability to recover systems and data quickly isn't just good IT practice; it's a regulatory expectation that prevents compliance issues and supports uninterrupted business operations.
The Compliance Advantage: Why a Unified Platform Wins
The transformative benefit isn't that Propel handles each compliance area; it's that everything works together on a single platform with complete traceability across all functions.
Consider a typical scenario: A customer complaint triggers a CAPA investigation. That investigation identifies affected products requiring specification updates. The specification changes require new supplier declarations and SCAR processes with service providers. Engineering changes necessitate document updates and training for affected personnel. Each action generates electronic records requiring compliant signatures and audit trails.
In fragmented systems, this scenario creates multiple compliance issues:
- Manual data re-entry across multiple platforms
- Broken traceability chains between systems
- Version control nightmares
- Compliance gaps where information doesn't flow
- Enormous effort during audits to reconstruct the story
- Increased compliance risk and potential for non-compliance
In a unified platform like Propel, the entire chain of events is automatically linked, fully traceable, and audit-ready. Quality connects to engineering, engineering connects to training, training connects to product compliance, all with validated electronic signatures and comprehensive audit trails.
This connected approach delivers measurable business value: faster issue resolution, reduced compliance overhead, lower risk of regulatory findings, and improved operational efficiency. In an era of increasing regulatory complexity, a unified platform isn't a luxury; it's a competitive advantage for stakeholders across the organization.
Frequently Asked Questions
What is FDA 21 CFR Part 11 and why does it matter?
FDA 21 CFR Part 11 establishes the requirements for electronic records and electronic signatures to be considered trustworthy and equivalent to paper records. It requires controls around access, audit trails, validation, and the ability to generate accurate copies of records. Compliance officers rely on these controls to prevent non-compliance and demonstrate proper record-keeping to government agencies.
How does a unified platform reduce compliance costs compared to separate systems?
Research shows dramatic cost reductions from unifying platforms and compliance processes. Unified platforms eliminate redundant data entry, reduce system maintenance overhead, improve business processes, and minimize compliance risk while supporting better corporate governance.
Why is SOC 2 Type II important for compliance platforms?
SOC 2 Type II examinations provide independent verification that a service organization's controls related to security, availability, processing integrity, confidentiality, and privacy are appropriately designed and operating effectively over time. For companies entrusting sensitive quality and product data to a platform—especially personal data protected under GDPR or health information under HIPAA—this provides assurance that cybersecurity controls, data breach prevention, and system reliability meet professional standards.
Ready to eliminate compliance gaps?
Learn how Propel's validated platform unifies quality management, electronic records, product compliance, and security. Explore our certifications or request a demo.
