Compliance and Risk Management

Hyperfly embeds compliance into every step of the HCP engagement lifecycle — FMV enforcement, CAPS monitoring, DNE screening, audit trails, and full regulatory coverage across 50+ countries.
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Hyperfly Feature: Compliance and Risk Management — Always On

ComplianceFMVCAPSDNE100% Coverage

Compliance in HCP engagement cannot be an afterthought applied at the end of a workflow, a checklist that depends on individuals remembering to complete it, or a configuration option that can be switched off. In Hyperfly, compliance is foundational — it is embedded into the architecture of every workflow step, operating automatically from the moment an engagement is initiated to the moment it is reported.

Hyperfly Compliance Architecture

  • FMV enforcement — automatic, based on HCP type, country, and activity type
  • Real-time CAPS monitoring — across all active and pending engagements simultaneously
  • Automated DNE screening — public and private exclusion lists checked at every selection
  • Local regulatory rules — F&B, travel, pre-event documentation for 50+ countries, auto-updated
  • Exception handling workflows — structured compliance management when standard rules cannot be followed
  • Complete audit trails — every action, every user, every timestamp logged permanently
SOC 2 Type II GDPR Compliant 21 CFR Part 11 Sunshine Act Ready

Compliance by Architecture: The Hyperfly Difference

The critical distinction in HCP engagement compliance is between compliance that is enforced by architecture and compliance that is dependent on user behaviour. Most spreadsheet and CRM-based approaches rely on the latter — users are trained to follow SOPs, and compliance controls depend on that training being followed correctly, every time, by every team member, in every market.

Hyperfly enforces compliance architecturally. The platform makes non-compliant actions technically impossible rather than merely prohibited by policy:

Compliance ControlHow Hyperfly Enforces It
FMV enforcement FMV rates calculated and applied automatically. Compensation offers outside approved ranges are blocked at the point of engagement initiation — not flagged after payment is made
CAPS monitoring Real-time CAPS tracking across all active, pending, and provisionally planned engagements. New engagements that would breach CAPS limits are flagged before any contract is signed
DNE screening Automatic screening against public exclusion lists (OIG, state boards, debarment registers) and private internal lists at every selection — before any invitation can be sent
F&B compliance Food and beverage rules for every country are built into the platform and enforced per engagement — preventing spend that exceeds jurisdiction-specific limits
Travel compensation Travel reimbursement rules per country are applied automatically to every engagement budget, preventing non-compliant travel expense arrangements
Pre-event documentation Event-type-specific pre-documentation requirements are enforced as mandatory workflow steps — engagements cannot proceed without required documentation
Consent and data privacy GDPR-aligned consent status tracked per HCP — ToV reporting consent verified before non-anonymised reporting of HCP participation
Regulatory change management Changes in regulations across 50+ countries automatically update workflow rules — no manual reconfiguration required when local requirements change

Frequently Asked Questions

What happens in Hyperfly when a compliance rule cannot be followed — for example, when an FMV exception is genuinely needed?

Hyperfly’s exception handling workflows manage legitimate exceptions in a structured, documented way. When an FMV exception, CAPS waiver, or other compliance deviation is required, the system routes a formal exception request to the appropriate compliance reviewer with full documentation of the rationale. The exception is reviewed, approved or rejected, and recorded in the audit trail — maintaining compliance integrity even in edge cases rather than forcing teams into informal workarounds.

How does Hyperfly handle compliance across different regulatory environments — for example, between EFPIA requirements in Europe and Sunshine Act requirements in the US?

Hyperfly maintains separate, market-specific regulatory rule sets for every country in its 50+ country deployment — including jurisdiction-specific FMV rates, CAPS limits, F&B rules, travel compensation standards, and transparency reporting formats. A single global HCP engagement programme running across the US and multiple European markets will have the correct compliance rules applied automatically per country without any manual reconfiguration between markets. → Read: Hyperfly for Global Pharma

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