Compliance That Works in the Real World
Regulatory compliance is not a documentation exercise — it is an operational discipline. AxiomAim builds compliance programs that satisfy auditors and work alongside your engineering and operations teams without grinding productivity to a halt. With direct experience managing FDA 21 CFR Part 11-compliant platforms, HIPAA-covered environments, and SOC 2 programs through live audits, we know what regulators actually look for — and how to build systems that pass.
What We Deliver
Compliance Program Design
Design end-to-end compliance programs tailored to your regulatory obligations — HIPAA, FDA 21 CFR Part 11, SOC 2, GxP, or ISO 27001. We translate regulatory requirements into implemented technical controls, operational procedures, and governance structures that hold up to scrutiny rather than just filling a policy binder.
Audit Readiness & Evidence Management
Prepare your organization for regulatory audits and third-party assessments with structured evidence collection, control mapping, and gap remediation. We build audit readiness into your operational workflows — so evidence is generated automatically as you operate, not assembled in a panic before the auditor arrives.
Software Validation (IQ / OQ / PQ)
Design and execute installation, operational, and performance qualification protocols for regulated software systems — electronic data capture, LIMS, clinical trial management systems, and custom SaaS platforms. Validation documentation is written to satisfy FDA inspectors and internal quality teams without over-engineering the process.
Policy & Procedure Development
Write and operationalize the SOPs, security policies, data management plans, and system documentation your compliance framework requires. Policies are written in plain, enforceable language — not boilerplate that no one reads or follows — and are integrated into your actual operational processes from the outset.
Gap Assessment & Remediation Planning
Evaluate your current compliance posture against applicable regulatory standards and identify gaps before an auditor does. We produce prioritized remediation plans with clear ownership, effort estimates, and sequencing — so your team knows exactly what to fix first and why it matters.
Compliance Training & Culture
Build compliance awareness into your organization through role-specific training programs, onboarding materials, and ongoing education for engineering, operations, and leadership teams. Sustainable compliance depends on people understanding the why behind the controls — not just following rules they resent.
How We Engage
Compliance programs fail when they are designed in isolation from the engineering and operations teams who must live with them. We work across both disciplines — bringing regulatory expertise and technical depth to every engagement.
Assess
Evaluate your current compliance posture against applicable regulations — identifying control gaps, documentation deficiencies, and technical risks. Deliverable: a gap report with prioritized findings and a remediation road map tied to your audit timeline.
Build
Implement the technical controls, documentation, and operational procedures your compliance framework requires — working alongside your engineering team to embed compliance requirements into your systems and workflows, not alongside them.
Sustain
Establish ongoing monitoring, periodic review cycles, change management procedures, and internal audit processes that keep your compliance program current as your systems and regulatory landscape evolve. Compliance achieved once must be maintained continuously.
Regulatory Frameworks
Thomas Powell has managed compliance programs through live regulatory audits and third-party assessments across the most demanding frameworks in healthcare, life sciences, and enterprise software.
FDA 21 CFR Part 11
Electronic records and signatures for clinical trial platforms, EDC systems, and life sciences SaaS — from software design through IQ/OQ/PQ validation.
HIPAA
Technical safeguards, administrative controls, BAA management, breach notification procedures, and risk analysis documentation for ePHI-handling systems.
SOC 2 Type II
Trust Services Criteria control design, evidence collection workflows, vendor management, and audit support for Security, Availability, and Confidentiality.
GxP & ISO 27001
Good practice quality guidelines for pharmaceutical and biotech environments, and ISO 27001 information security management system implementation and certification preparation.