Pharma Director EA FAQs - Why do 150 IT projects ≠ Pharma Enterprise Architecture?
- Sunil Dutt Jha
- 6 days ago
- 5 min read
Updated: 3 days ago
Most pharmaceutical organisations still treat Enterprise Architecture as an IT exercise, which is why EA efforts don’t change R&D productivity, regulatory approval timelines, manufacturing yield, quality compliance, supply reliability, or commercial execution.
Pharma EA ≠ Pharma IT.
This Director EA FAQ explains where traditional EA breaks down and how a true enterprise anatomy reveals the structure that IT alone cannot see, align, or repair.
It explains the logic of shadow anatomies, 12 pharma use cases, and the One Pharma One Anatomy™ advantage.
Q1: Why do 150 IT projects ≠ Pharma Enterprise Architecture?
Myth:
Pharma EA = Pharma IT (LIMS upgrade + ERP modernisation + QMS digitisation + CRM transformation).
Reality:
A pharmaceutical enterprise operates through 15 departments (D1–D15) such as Research, Pre-Clinical, Clinical Development, Regulatory Affairs, Quality, Manufacturing, Supply Chain, Validation, Pharmacovigilance, Medical Affairs, Sales, Marketing, Finance, and Compliance — each with its own P1–P6 execution cycle.
Pharma IT is only one department.
EA (IT) ≠ Enterprise Anatomy.
A project inventory cannot show how scientific decisions, regulatory rules, quality controls, manufacturing logic, supply constraints, and commercial execution align across the enterprise.
Q2. Why do so many IT projects fail to represent the pharma enterprise?
Because pharma IT automates only small fragments of P5 tasks, while the true operating architecture of the pharmaceutical enterprise lives in P1–P4, not in the task layer.
Every pharma department operates on a full P1–P6 structure:
P1 (Strategy) defines portfolio strategy, therapeutic focus, pipeline priorities, and risk appetite.
P2 (Processes) defines research workflows, clinical trials, regulatory submissions, manufacturing, quality assurance, release, and distribution.
P3 (System logic) defines study protocols, eligibility rules, validation logic, batch rules, deviation handling, change control, and safety reporting logic.
P4 (Component Spec) defines protocols, master data, specifications, batch records, validation documents, dossiers, and datasets.
This is the architecture of the pharma enterprise.
Most IT projects touch P5 only — automating selected tasks such as data capture, document management, workflow routing, reporting, or submissions — while P1–P4 remains fragmented, manual, or interpreted differently across departments.
The mismatch is structural:
IT systems automate "tasks" (P5).
Pharma operates on scientific, regulatory, and quality architecture (P1-P4 X D1-D15).
Because P1–P4 was never architected:
• protocols vary across studies and sites
• validation logic is inconsistently applied
• deviations are handled differently across plants
• regulatory interpretations diverge across regions
• safety reporting logic fragments
• release decisions differ across batches
Pharma IT does not fail because systems are weak. It fails because it is built on an incomplete representation of the enterprise.
Q3. What drives the high project count in the pharma industry?
Pharma is a highly regulated, rule-dense industry where every change cascades across multiple functions.
A change in molecule strategy impacts R&D, clinical design, regulatory planning, and manufacturing readiness.
A regulatory update alters documentation, validation, submissions, and audit trails.
A manufacturing change affects batch logic, quality checks, release rules, and supply commitments.
A safety signal impacts pharmacovigilance, labeling, regulatory communication, and medical affairs.
A market or pricing change affects forecasting, supply planning, and commercial execution.
High project count reflects scientific, regulatory, and quality complexity, not IT inefficiency.
Q4. What is unique about Pharma’s 15 Functions (D1–D15)?
Each pharmaceutical organisation has a distinctive 15-function anatomy (D1–D15 × P1–P6).
Pharma highlights:
D1 Research & Discovery – governs scientific hypotheses and early validation
D3 Clinical Development – governs study design, protocols, and trial execution
D5 Regulatory Affairs – governs submissions, approvals, and correspondence
D7 Manufacturing – governs batch execution and production logic
D9 Quality & Validation – governs deviations, CAPA, and compliance
D11 Pharmacovigilance – governs safety signal detection and reporting
D13 Medical Affairs – governs scientific communication and evidence dissemination
These functions generate the strongest P1–P6 drift when not aligned.
Shadow anatomies emerge when departments evolve independently without a single enterprise model.
Q5. What does P1–P6 look like in the pharma industry?
This explains how strategy (P1) → operations (P6) breaks down.
P1 Strategy: portfolio priorities, therapeutic focus, risk and investment decisions.
P2 Process: research, trials, submissions, manufacturing, quality, release, distribution.
P3 Logic: protocol rules, eligibility criteria, validation logic, batch rules, safety reporting.
P4 Components: protocols, specifications, master data, batch records, dossiers.
P5 Implementation: IT workflows, document systems, integrations, manual checks.
P6 Operations: scientists, QA teams, plant operators applying rules differently.
Pharma drift occurs when these layers no longer form one integrated sequence.
Q6. We already have extensive architecture documentation. Why redo this?
Myth: More documentation means we understand the enterprise.
Reality:
Documentation shows parts of the pharma organisation. Enterprise Anatomy shows the pharma organisation as one integrated model.
Think of the human body.
It has 11 organ systems. Each has its own role, but none operate independently. They function as one integrated system with thousands of interdependencies.
A pharmaceutical enterprise is the same.
A pharma anatomy = 15 Functions (D1–D15) × 6 Perspectives (P1–P6).
Traditional documentation describes systems, protocols, validations, and reports separately — but never shows:
• how research decisions affect manufacturing • how regulatory logic impacts quality operations • how deviations propagate across plants • how safety rules affect commercial execution• where structural risk accumulates
You get a library — not a model.
One Pharma One Anatomy™ collapses complexity into one integrated enterprise model.
Q7. How do we evolve from EA (IT) → EA (Departments) → One Pharma One Anatomy™?
Most organisations stop at EA = IT architecture.
The next evolution is:
Step 1: Elevate EA (IT)
Create the P1–P4 model of Pharma IT (LIMS upgrade + ERP modernisation + QMS digitisation + CRM transformation) itself — IT strategy, IT processes, IT logic, IT components.
Step 2: Create EA (Departments)
Map 15 pharma functions end-to-end (P1–P6).
Step 3: Create One Pharma One Anatomy™ Unify all departmental models into one enterprise anatomy governing science, quality, manufacturing, compliance, and commercial execution.
This is where drift stops — and predictability begins.
Q8. What can One Pharma One Anatomy™ do that traditional EA cannot?
Traditional EA documents systems. It cannot see that every department is running its own shadow anatomy.
A mid-size pharma company typically carries 100–300 shadow anatomies:
• different protocol interpretations • different validation and quality logic • different regulatory compliance models• different safety reporting rules • different release and supply decisions
Traditional EA documents this drift. One Pharma One Anatomy™ eliminates it.
How it Impacts the 12 Core Pharma Use Cases
Using One Pharma One Anatomy™, the enterprise can address failures across:
R&D Pipeline Governance
Clinical Trial Consistency
Regulatory Submissions & Approvals
Quality & Validation Control
Batch Release & Compliance
Deviation & CAPA Management
Pharmacovigilance & Safety Reporting
Manufacturing Yield & Predictability
Supply Chain Reliability
Labeling & Change Control
Audit & Inspection Readiness
Commercial & Medical Alignment
With One Pharma One Anatomy™, these use cases become predictable and controllable — because they run on one enterprise logic stack.
If EA remains limited to IT, Pharma companies continues to drift — rule by rule, service by service, region by region. A Pharma regains coherence only when its entire P1–P6 structure is mapped as One Pharma One Anatomy™.
If you’d like a diagnostic walk-through of how this applies to your environment, write to us and we will prepare it.
