Compliance Radar

It is the second Tuesday of the quarter at the Leuven API manufacturing facility. The Quality Director opens ProBeya's Compliance Radar and reviews the dashboard before the Management Review meeting. The radar shows 247 tracked requirements across four frameworks: EU GMP Annex 11 (78 requirements), FDA 21 CFR Part 11 (52), ICH Q10 (68), and EU GMP Annex 15 (49). Of these, 221 are compliant, 8 have gaps identified, 14 have remediation in progress, and 4 are non-compliant. The 4 non-compliant items are all high-risk — and all four have linked corrective actions with due dates within the next 30 days.

She filters by "next assessment overdue" and finds 12 requirements that have not been reassessed in over 12 months. She assigns assessors and schedules the reviews. In 20 minutes, she has a complete picture of the organization's regulatory posture, evidence of management oversight, and a prioritized remediation plan — exactly what the upcoming EMA inspection team will ask for.

Why Compliance Radar Exists

Regulated organizations face hundreds of compliance requirements across multiple frameworks. In pharma manufacturing, these requirements are not academic — non-compliance can result in warning letters, consent decrees, import alerts, or facility closures. The 2023 FDA Warning Letter to a major CDMO cited "failure to maintain a system for tracking and remediating compliance gaps" as a primary finding.

The challenge is not knowing the requirements. Every quality professional knows EU GMP and 21 CFR Part 11. The challenge is tracking the current state of each requirement across time: Which requirements are met? Which have gaps? Which are overdue for reassessment? Who owns what? Where is the evidence?

Spreadsheets fail at this for three reasons: they lack an audit trail, they have no concept of assessment history, and they cannot aggregate across frameworks to give leadership a unified view.

Compliance Radar solves these problems by treating each regulatory requirement as a tracked, assessed, risk-classified entity with full history.

For Quality Directors

Compliance Radar is not a replacement for your quality management system (QMS). It is the management layer that sits above your QMS and gives you — and your executive team — real-time visibility into the organization's compliance posture. Use it to prepare for inspections, drive management reviews, and prioritize remediation resources.

Registering Compliance Requirements

Each requirement represents a single clause or control from a regulatory framework.

Creating a Requirement

1. Navigate to the Compliance Radar section
2. Click New Requirement
3. Fill in the requirement details:

Field	Description	Example
Framework	Regulatory framework name	"EU GMP Annex 11"
Clause	Specific section reference	"12.4"
Title	Short description	"Segregation of duties for data review"
Category	Grouping label	"data integrity"
Applicability	Whether it applies to this organization	Applicable / Not Applicable / Partial
Status	Current compliance state	Compliant / Non-Compliant / Gap Identified / Remediation in Progress
Risk Level	Impact classification for non-compliance	Low / Medium / High / Critical
Owner	Person responsible for maintaining compliance	QA Manager
Evidence	Supporting documentation (JSONB)	Links to SOPs, validation reports, screenshots
Next Assessment Due	Scheduled date for periodic review	2026-07-15

Applicability Assessment

Not every requirement applies to every organization. A facility that does not use electronic signatures may mark FDA 21 CFR Part 11 Section 11.200 (electronic signatures) as "Not Applicable" — but must document the rationale. The applicability field captures this decision.

Applicability	Meaning
Applicable	Requirement applies and must be assessed
Not Applicable	Requirement does not apply — document rationale
Partial	Requirement partially applies — document scope

Bulk Import by Framework

When onboarding a new regulatory framework, create requirements from the official clause list rather than cherry-picking. This ensures complete coverage from day one. It is far better to mark 30 requirements as "Not Applicable" with documented rationale than to discover during an inspection that you missed a requirement entirely.

Compliance Statuses

Status	Meaning	Action Required
Compliant	Requirement fully met with documented evidence	Schedule periodic reassessment
Non-Compliant	Requirement not met	Immediate remediation — create corrective action
Gap Identified	Assessment revealed a gap that needs investigation	Investigate scope and plan remediation
Remediation in Progress	Corrective actions are underway	Monitor progress, track due dates

Risk Classification

Level	Description	Inspection Impact	Response Time
Low	Minor finding, limited regulatory impact	Observation	Plan within 90 days
Medium	Moderate risk, requires planned remediation	483 observation likely	Plan within 30 days
High	Significant risk, priority remediation needed	483 observation + Warning Letter risk	Remediate within 15 days
Critical	Immediate regulatory exposure	Warning Letter / Consent Decree risk	Remediate immediately

Risk-Based Prioritization

Focus remediation on Critical and High risk non-compliant items first. The risk-level dashboard view helps leadership allocate scarce QA resources where they matter most. A site with 200 compliant items and 4 critical non-compliant items is in worse shape than a site with 180 compliant items and 20 low-risk gaps — and the dashboard makes this visible.

Periodic Assessments

Compliance is not a one-time event. Requirements must be reassessed periodically to ensure ongoing compliance. ProBeya captures assessments as point-in-time evaluations.

Recording an Assessment

Each assessment captures:

Field	Description
Assessor	Authenticated user conducting the assessment
Previous Status	Captured automatically from the requirement
New Status	Updated compliance state after assessment
Findings	Detailed text describing assessment results
Evidence	Links to supporting documents, screenshots, system outputs
Recommended Actions	Next steps if gaps were identified

When an assessment is created, the parent requirement's status and lastAssessedAt timestamp are automatically updated.

Worked Example: EU GMP Annex 11 Section 12.4 Assessment

Requirement: "Electronic records must include a clear indication of who performed the review and when."

Annual assessment by QA Manager:

• Previous Status: Compliant
• Findings: "Reviewed the MES audit trail configuration. All batch record review activities log the reviewer's user ID and timestamp. However, the new LIMS module (installed Q3 2025) does not capture reviewer identity for OOS result reviews. Gap identified."
• New Status: Gap Identified
• Risk Level: Updated from Low to High (data integrity impact)
• Evidence: Screenshots of MES audit trail (compliant) and LIMS audit trail (gap)
• Recommended Actions: "LIMS vendor to implement reviewer tracking in next release (Q2 2026). Interim manual procedure SOP-QC-089 implemented."

This assessment creates a dated, attributed record showing that the organization actively monitors compliance and responds to gaps — exactly the evidence that regulators want to see.

The Dashboard

The compliance dashboard provides the aggregated view that leadership needs:

Status Distribution

Status	Count	Percentage
Compliant	221	89.5%
Gap Identified	8	3.2%
Remediation in Progress	14	5.7%
Non-Compliant	4	1.6%

Risk Distribution

Visual breakdown of non-compliant and gap items by risk level — highlights where the organization is most exposed.

Framework Breakdown

Compliance posture by regulatory framework — useful for preparing for framework-specific inspections (e.g., an upcoming FDA pre-approval inspection focuses on 21 CFR Part 11 items).

Overdue Assessments

Requirements where nextAssessmentDue has passed without a new assessment — these are the items that auditors will flag during an inspection as evidence of inadequate self-inspection programs.

Regulatory Framework Reference

Compliance Radar is designed to track requirements from any regulatory framework. Common frameworks used in pharma manufacturing:

Framework	Scope	Typical Requirement Count
EU GMP Annex 11	Computerized systems	70-90
FDA 21 CFR Part 11	Electronic records and signatures	40-60
ICH Q10	Pharmaceutical quality system	60-80
EU GMP Annex 15	Qualification and validation	40-60
EU GMP Annex 1	Sterile manufacturing	100-150
ISO 13485:2016	Medical device quality management	50-80
PIC/S PE 009	GMP inspection guidance	80-120

Preparing for an Inspection

Two weeks before a regulatory inspection, filter Compliance Radar by the relevant framework. Ensure all requirements are assessed within the last 12 months, all non-compliant items have active remediation plans with evidence, and the dashboard can be presented to inspectors as evidence of your self-inspection program. This preparation alone can shift an inspection from adversarial to collaborative.

Integration with the Quality System

Compliance Radar connects to the broader ProBeya ecosystem:

• Action Log: Create corrective actions directly from non-compliant requirements — tracked with the same TIER-based escalation as all other actions
• KPI Boards: Track compliance KPIs (e.g., "% requirements compliant", "overdue assessments count") on your Quality SQCDP board
• Inspections Module: Run mock inspections against your requirement baseline to test audit readiness
• TIER Meetings: Review critical compliance items during TIER 3 monthly steering meetings

Permissions

Action	Required Role
Create/edit requirements	Compliance manager or admin
Record assessments	Compliance assessor or admin
View requirements and dashboard	Any organization member
Assign owners	Compliance manager or admin

Related Features

• Inspections — Run simulated inspections to prepare for regulatory audits
• IFQHC Framework — Competency assessments aligned with compliance requirements
• Action Log — Create and track actions for remediation of compliance gaps
• KPI Boards — Track compliance KPIs (% compliant, overdue assessments, remediation velocity)