HDI Audit

HDI Phase 1

Human Dependency Indicator
Pharma & Life Sciences

1
Profile
2
Questionnaire
3
Industry KPIs
4
Results
Step 1 of 4

Before we begin

This questionnaire collects information about your organisation\'s operational processes to calculate an HDI (Human Dependency Indicator) score. Please read and confirm the following before proceeding.

What data we collect

We collect your answers to operational questions, your organisation\'s industry and size, and your contact email. We do not collect patient data, clinical records, or any personally identifiable information about third parties.

How we use it

Your data is used solely to calculate your HDI score and prepare an audit report for your organisation. It is not shared with third parties, not used for advertising, and not sold under any circumstances.

How long we store it

Your data is retained for 24 months after the audit is completed, after which it is deleted on request or automatically. You may request deletion at any time by contacting us.

Your rights

Under GDPR you have the right to access, correct, export or delete your data at any time. To exercise these rights, contact the auditor who shared this link with you.

Please accept the data processing agreement to continue.

Company Profile

Company name (optional)
Helps us label your results. Leave blank if you would rather stay anonymous at this stage.
P1.Industry / sector
Determines KPI weights, HDI layer weights, regulatory context and Human Error Risk Severity coefficient.
P2.Operational team size
Count only people involved in the operations covered by this assessment (manufacturing, QA/QC, regulatory, supply chain, lab). Exclude general admin, finance, HR.
P3.Company stage
Earlier-stage companies typically have higher HDI because processes are less formalised. M&A context raises the urgency of every finding.

Regulatory Environment

P5.Which regulatory standards apply to your operations?
Select all that apply. This raises the Control HDI weight and Severity coefficient.
GMP
GxP
FDA 21 CFR Part 11
EMA Guidelines
ICH Q10
ATMP Reg. EC 1394/2007
GCP
GDP
ISO 15189
None / In progress

Audit Scope

P6.What do you want to achieve with this HDI audit?
Select all that apply. Your goals determine which findings appear as priorities and which recommendations are surfaced first.
Reduce regulatory risk
Reduce human error risk
Build the business case for automation
Quantify hidden operational losses
Reduce key-person dependency
Prepare for scale-up
Prepare for FDA / EMA inspection
M&A readiness / Due Diligence
Reduce Time-to-Batch / Time-to-Patient
Optimise staffing and reduce overtime
Improve cross-department visibility
Reduce onboarding time for new hires
P7.Which processes should be included in this audit?
Selected processes appear in the HDI Heatmap in your results.
QA / QC Operations
Batch Record Management
Deviation & CAPA
Chain of Identity (CoI)
Chain of Custody (CoC)
Supply Chain / Cold Chain
Regulatory Affairs
Clinical Data Management
Manufacturing Execution
HR / Operator Qualification
Lab Operations
Change Control
Procurement / Vendor Management
Cryogenic Logistics
Patient Scheduling (CGT)
Document Management & Archiving
Environmental Monitoring
Supplier Qualification
Equipment Calibration & Maintenance
Training & Competency Management

Block A -- Coordination & Approvals

A1.How many manual approvals does a typical task go through before it is executed?
Count every step where work waits for a specific person: a QMS approval, a signature, a verbal OK, an email confirmation.
Which approvals create the longest waiting time?
QA Director / Qualified Person
Regulatory Affairs review
Medical / Safety Officer
Cross-department sync
External partner / sponsor
Legal / Compliance
A2.How many status update meetings happen per week -- solely to find out where things stand?
Not strategic sessions -- synchronisation meetings only. Every such meeting signals that information is not visible without human intervention.
A3.How are tasks and operations assigned to the people who execute them?
Think about a typical critical operation -- assigning a batch record review, scheduling a cleanroom operator, or routing a deviation investigation.
A4.If the person responsible for a critical process is unavailable for 3 working days -- what happens?
Think of a real scenario: illness, sudden resignation, emergency leave. Be honest -- the actual outcome, not the ideal one.
Which processes are most vulnerable in this scenario?
Closing deviations / CAPA
Approving batch records
Communication with FDA / EMA
Manufacturing go / no-go decisions
Managing key suppliers
Patient / donor scheduling (CGT)
Critical technical systems
A5.How is cross-departmental coordination handled for a critical process?
Example: QA to Production to Supply Chain for batch release. How does information move between them?

Block B -- Quality Control & Data Verification

B1.For each department -- what percentage of documents or records are reviewed manually before finalisation?
Manual review means a person reads, compares or signs before the document is considered complete. Select only departments relevant to your organisation.
B2.How does your team typically find out about a problem in a process?
Parameter out of range, missed deadline, data error, production deviation -- how does information reach the right people?
B3.How long does it take to fully close an incident or deviation -- from detection to system closure?
GMP: deviation + CAPA. Clinical: protocol deviation + resolution. Logistics: temperature excursion + GDP investigation. Think about the typical case, not the best case.
What most commonly causes the delay?
Waiting for QA Director / QP approval
Gathering data manually from multiple systems
Cross-department sign-off chain
Root cause analysis is time-consuming
No defined SLA -- nobody owns the deadline
B4.In the past 12 months -- how often did errors caused by human factors occur when handling data or documents?
Examples: incorrect entry in batch record, wrong data copied between systems, missed signature, mislabelled sample, duplicate record created.
Most typical consequences:
Rework / repeat task
Delayed batch release
FDA / EMA warning or information request
Financial loss
Patient safety risk
Loss of CGT sample or material
Delay to clinical trial timeline
B5.Are there documented SLAs -- timeframes -- for closing critical operations?
For example: deviation must close within 30 days, batch record within 48 hours of production completion.

Block C -- Routine Work & Cognitive Load

C1.Select a department and a specific task to evaluate in detail
We assess one concrete process, not the entire company. Choose the most representative task from your area of responsibility.
C2.How many separate systems, files or sources does a person need to access to complete this task?
Count each one: ERP, QMS, LIMS, an Excel file, a paper log, an email thread with data, a shared folder. Every source requiring switching is cognitive overhead.
4 sources
C3.What proportion of data is transferred between systems manually?
Manual transfer means copy-paste, retyping, transcribing from one form into another. This is the primary source of Human Error Risk in Cognitive HDI.
C4.If the volume of this process doubled tomorrow -- how would you handle it?
Think about 2x more batches, patients, documents or samples. "The system handles it" vs "we would hire more people" is the key distinction.
C5.Are there tasks or knowledge areas concentrated in a single person?
If that person leaves or falls ill, the process would stop or quality would drop critically. Be candid -- this is the Bus Factor diagnostic question.
In which areas is knowledge concentrated?
QA / regulatory expertise
Manufacturing protocols / process knowledge
FDA / EMA relationship management
Key supplier / partner relationships
Technical systems (LIMS / QMS / MES)
Patient / donor logistics (CGT)
C6.How is a typical operational report created?
Consider the most common report your team produces -- batch report, QA summary, stability report, clinical study report. Include time spent gathering data, formatting and routing for review.

Industry-Specific KPIs

Select your industry on Step 1 to see industry-specific KPIs here.
Your Results · Phase 1 Screening --
--% Total HDI
-- confidence
Coordination--
Control--
Cognitive--
Operational Leak--
Time absorbed by manual coordination and handovers
Confidence Score · --
--
Coordination HDI
--
Control HDI
--
Cognitive HDI
--

Process HDI Heatmap

ProcessCurrentTarget

What the full audit adds

This screening is the diagnosis: where human dependency sits, and how much time it absorbs. A full Phase 2 audit interprets it and turns it into a plan. It adds:
  • Decoded findings — what each score actually means for your processes, verified in a structured workshop with your team rather than inferred from a questionnaire.
  • Prioritised automation entry points — which specific workflows to change first, and why those before the others.
  • Perception gap — how leadership's view of the operation compares with the frontline experience, measured rather than assumed.
  • Money quantification — the cost of the dependency, calculated on rates and assumptions agreed with you, not on defaults.
  • Implementation plan — a sequenced roadmap with the monitoring metrics to track whether it is working.