Digital Enablement & Compliance
Quality, Risk & Compliance for Regulated Industries
End-to-end quality and compliance for pharma, biotech, and medical device companies — from QMS design and audit readiness through validation, design controls, and post-market surveillance. Built on deep regulatory expertise and augmented by Trinity's AI tooling.
Book a Free ConsultationDigital & IT Quality
Digital quality & IT compliance
Digitization & Automation for eQMS
Transform Quality Management Systems through cutting-edge digitization and automation — reducing manual effort and audit risk.
IT Quality Management System Development
Craft bespoke IT Quality Management Systems to meet regulatory requirements and organizational needs.
Digital Compliance Transformation
Guide organizations through transformative compliance journeys to meet industry standards — FDA, EMA, HIPAA, GDPR, and more.
IT General Controls, Privacy & Audits
Ensure robust IT governance through comprehensive controls, privacy measures, and audit readiness.
Enterprise Risk Management
Strategically identify, assess, and mitigate risks to optimize business performance and protect operations.
Data Integrity, Governance & Framework
End-to-end solutions for data integrity, robust governance, and sustainable data frameworks in regulated environments.
Information Security Assessment
Comprehensive assessments to identify and fortify against cybersecurity threats before they become regulatory findings.
HIPAA & GDPR Assessment and Compliance
Navigate complex healthcare and data protection regulations to achieve and maintain compliance.
483 / Warning Letter / Audit Finding Remediation
Expertly address regulatory findings and audit issues with precision — developing corrective action plans that satisfy regulators.
IT Vendor Audit Support
Assist organizations in conducting thorough audits of IT vendors — ensuring your supply chain meets compliance requirements.
QMS / eQMS / GxP Audits
Conduct audits to ensure compliance and continuous improvement in quality management across GMP, GCP, and GLP environments.
Device Safety & Security Dashboard
Advanced dashboard development for real-time monitoring and management of device safety and security.
Quality Systems & Operations
Build and run the quality system
The day-to-day infrastructure that keeps you compliant — from QMS design and SOPs to CAPA, change control, and the metrics that prove it all works.
QMS Design & Implementation
Stand up ISO 13485 (devices) or ICH Q10 (pharma) compliant quality systems from the ground up — structured for audit readiness from day one.
SOP & Work Instruction Development
Author and refine SOPs, work instructions, and forms. AI-assisted drafting accelerates turnaround while subject-matter review keeps every procedure inspection-ready.
Quality Manual Creation
Develop the high-level quality policy and manual that anchors your organization's compliance commitments and ties the quality system together.
CAPA Management
Investigate root causes and drive Corrective and Preventive Actions to closure with a structured, repeatable methodology — built to surface the systemic patterns that single investigations miss.
Change Control
Manage the impact of changes to products, processes, and systems through controlled, traceable workflows that hold up under inspection.
Document Control
Manage the full lifecycle of controlled documents and training records — closing version-control and audit-trail gaps before they become findings.
Quality Metrics Dashboards & Management Review
Build live KPI dashboards that turn quality data into management-review-ready insight — data-informed decisions instead of quarterly spreadsheet scrambles.
Process Capability Analysis (Cpk/Ppk)
Evaluate manufacturing process performance to keep output consistently within specification limits and catch drift before it reaches the product.
Lean & Six Sigma for Quality
Apply continuous-improvement methodologies to cut waste, variability, and cycle time across your quality operations.
Regulatory Compliance & Audit
Inspection-ready, every time
Face regulatory scrutiny with confidence — proactive gap assessments, mock inspections, and audit support, plus the supplier controls that hold your network to the same standard you hold yourself.
Mock FDA / ISO Inspections
Run full dress-rehearsal inspections that surface gaps, weak narratives, and document holes before the real inspectors arrive.
External Audit Support
Provide front-room/back-room "war room" management during FDA, notified-body (ISO), and customer audits — keeping responses tight and consistent.
Regulatory Gap Assessments
Benchmark current processes against 21 CFR Parts 210/211 (GMP), 820 (QSR), and Part 11 (electronic records) to find exposure before regulators do.
Internal & Supplier Audits
Serve as your independent auditor across internal departments and contract manufacturers (CMOs/CDMOs) — objective, evidence-based, and remediation-focused.
Supplier Qualification & Approved Supplier Lists
Establish vendor evaluation criteria and maintain a compliant, defensible approved supplier list that holds your supply chain to your own standards.
Quality Agreements
Draft and negotiate quality agreements that clearly define roles, responsibilities, and quality expectations with suppliers and contract partners.
Incoming Inspection Program Design
Build risk-based inspection protocols that verify incoming materials and components against defined acceptance criteria.
Product Quality & Lifecycle Assurance
From design controls to post-market
Support your product from concept through commercialization and beyond — design controls, validation, and risk management on the front end; complaints, surveillance, and recall readiness once it's on the market.
Design Controls
Establish and maintain the Design History File (DHF) so device development meets design-control requirements from concept through transfer.
Risk Management (ISO 14971)
Lead FMEA sessions and build Risk Management Files — including premarket cybersecurity risk management for Software as a Medical Device (SaMD).
Computer System Validation (CSV / CSA)
Validate software and automated systems under GAMP 5, applying CSA's risk-based "test what matters" approach to cut validation overhead.
Equipment & Process Validation
Design and execute IQ/OQ/PQ protocols for manufacturing equipment and processes — verified, documented, and inspection-ready.
IEC 62304 Software Lifecycle (SaMD)
Bring Software as a Medical Device development into IEC 62304 classification and documentation compliance.
Combination Product Strategy (21 CFR Part 4)
Build integrated quality strategies for drug-device-biologic combination products, including primary-mode-of-action determination support.
Complaint Handling, AE Reporting & MDRs
Run the full pipeline from complaint intake through reportability determination and submission — US MDRs and EU MDR/IVDR vigilance and PSURs.
Recall Management
Lead product removals and corrections — from health-hazard evaluation (HHE) and strategy development through coordination with regulatory agencies.
Post-Market Surveillance (PMS / PMCF)
Develop and maintain proactive surveillance plans and clinical follow-up reports that satisfy EU MDR post-market requirements.
Trend Analysis & Signal Detection
Monitor complaint, nonconformance, and field data to catch emerging quality and safety signals before they escalate into findings or recalls.
Periodic Safety Update Reports
Compile aggregated adverse-event data, trends, and benefit-risk assessments into submission-ready periodic safety reports.
Strategic & Advisory
Advisory & specialized capabilities
Key Benefits
How we make a difference
Built-in Compliance
Frameworks designed for regulated environments from day one — not retrofitted after the fact.
Reduced Risk
Proactive risk identification and mitigation before audits, not in response to findings.
Speed & Agility
Streamlined quality and compliance processes that accelerate, not block, your business.
Reduced Quality Issues
Systematic controls that catch problems early and prevent costly recalls or remediation.
Industries
Who We Serve
Ready to simplify your compliance?
Let us assess your current state and identify the highest-leverage improvements.
Book a Free Consultation