A practical guide to ICS asset inventory and visibility in the Pharma Sector

Pharmaceutical manufacturing lives at the intersection of stringent quality expectations, heavy regulation, and unforgiving production economics. In such an environment, operational technology (OT) asset inventory and visibility are not just cybersecurity checklist items but instead they are essential for safeguarding patient safety, protecting intellectual property, and maintaining uninterrupted, validated production.

Today’s blog post aims to serve as a guide for asset inventory and tries to explain why visibility is uniquely challenging in pharma. It outlines risks and compliance drivers (IEC 62443, NIS2, and regional GxP requirements), and also provides a detailed, pragmatic checklist to achieve and sustain strong asset visibility.

Why asset visibility is different in the pharma sector

Pharma plants are not generic one size fits all factories. Several sector specifics make discovery and visibility harder and more consequential:

· Validation and change control (GxP context).

Any change to computerized systems touching GxP data (e.g., batch records from MES, historian data used in release decisions) may require validation and rigorous change control. Aggressive scanning or unplanned configuration changes can jeopardize validated states and trigger deviation investigations.

· Hybrid landscapes spanning IT, OT, and labs.

Pharma environments blend DCS/PLC/SCADA on the shop floor with MES/LIMS/ELN and QA/QC lab instruments, plus BMS/HVAC for cleanrooms. Many lab devices (e.g., chromatography systems) straddle IT and OT, often with legacy Windows endpoints and vendor-tuned network behavior. Visibility solutions must reach across these domains without breaking data integrity.

· Cleanroom and environmental controls.

HVAC/BMS systems, differential pressure sensors, and environmental monitoring devices directly influence product quality and compliance. Any visibility approach must respect these systems’ criticality and avoid causing alarms or control instabilities.

· Single-use technologies and frequent line reconfiguration.

Skids, single-use bioreactors, and modular equipment are attached and removed between campaigns. The asset population shifts frequently, and temporary vendor gear is common. Static inventories become stale quickly.

· Extended supply chains and CDMO models.

External partners (CMOs/CDMOs), serialization providers, and remote vendors often require access. That increases the number of unknown or semi-managed assets and introduces opaque connectivity paths that traditional IT inventories miss.

· Data integrity and traceability expectations.

Pharma lives by ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate). Visibility must extend beyond “what is on the network” to who changed what, when, and how, with audit trails suitable for inspections.

The risks and threats

Incomplete asset visibility amplifies several high-impact risks:

· Batch loss and production downtime.

A single compromised controller or workstation can halt sterile manufacturing or biologics processing. Downtime costs can be measured not only in revenue but in drug shortages and patient impact.

· Quality incidents and regulatory findings.

Untracked firmware, unauthorized engineering workstations, or misconfigured historian nodes can undermine data integrity. That invites deviations, CAPAs, and potential findings during inspections.

· Ransomware and disruptive malware.

Ransomware pivoting from IT to OT can encrypt batch records, MES servers, or domain controllers that production depends on. Without a current asset map, incident response is blind, recovery slower, and containment leaky.

· IP theft and recipe manipulation.

Adversaries targeting process setpoints, recipes, or analytics models can subtly degrade yield or quality, or exfiltrate valuable know-how.

· Third-party and remote access exposure.

Temporary vendor laptops, maintenance connections, or unmanaged HMIs create shadow assets and unmonitored pathways into critical networks.

Why asset visibility matters

· Foundation for ICS risk assessment and segmentation.
You can’t zone and conduit (Purdue, IEC 62443) what you can’t see. Asset inventories inform your trust boundaries, access controls, and monitoring points.

· Prerequisite for vulnerability and patch decisions.
Visibility tells you which firmware, OS builds, and protocols are present, critical to deciding whether to patch, compensate, or defer in a validated system.

· Speeds ICS incident response.
With a live map of devices, communication paths, and baselines, responders can isolate affected cells quickly, select validated failover procedures, and restore operations within MTTD/MTTR targets.

· Enables change control discipline.
Accurate inventories anchor MOC processes. Drift detection (new services, changed firmware, unexpected communication) surfaces unapproved changes.

· Supports audit readiness.
Demonstrable control over computerized systems, what exists, who accessed it, and how it’s monitored, reduces audit pain and improves regulator confidence.

· Learn what every asset is upto: So that there are no asset blindspots

Compliance drivers: IEC 62443, NIS2, and regional GxP

IEC 62443

• Program and risk context (e.g., 62443-2-1, 3-2): Asset identification and system partitioning (zones/conduits) are foundational activities. A maintained inventory with attributes (type, role, criticality, ownership, firmware) supports risk assessments and security design.

• System & component requirements (e.g., 62443-3-3, 4-2): Requirements around identification & authentication, use control, and system integrity rely on knowing what assets exist and their trust relationships.

NIS2 (EU)

Pharmaceutical manufacturing typically falls under “essential” or “important” entities across the health/medicinal products ecosystem. NIS2 requires risk management measures, incident reporting, and supply chain security. Asset management and visibility are implicit prerequisites to meet these obligations, inform risk treatment, and evidence governance.

GxP and data integrity (regional layers):

• EU GMP Annex 11 and FDA 21 CFR Part 11: Strong expectations around computerized system control, access, audit trails, and data integrity.

• MHRA/PIC/S guidance: Reinforces expectations for system lifecycle control, validation, and change management.

• Effective visibility underpins all of these by ensuring you know which systems are in scope for validation, how they’re configured, and how changes are tracked.

Takeaway for you: You don’t need to cite clause numbers during a walkthrough with production teams. Instead, tie visibility to the control intent, know your assets, control changes, monitor behavior, preserve data integrity, and then map that to your quality system and security program.

How to ensure asset visibility: A pharma-ready checklist

Use this as a stepwise playbook you can run site by site.

Define scope and governance

· Set the policy: Asset inventory is mandatory for all systems in GxP production, QA/QC labs, utilities (BMS/HVAC, WFI, clean steam), and supporting IT platforms (AD, DNS, backup, MES, LIMS).

· Nominate owners: Each system/asset has a business owner (often QA/Manufacturing), a technical owner (OT/Engineering), and a cybersecurity owner.

· Align with Quality: Bake inventory requirements into the site quality manual and MOC procedures to align with validation expectations.

Establish a safe discovery strategy

· Passive discovery first: Use OT-aware sensors on SPAN/TAP ports to identify devices, protocols (Modbus, PROFINET, EtherNet/IP, OPC UA), firmware, and communication patterns without touching endpoints.

· Vendor-approved active scans (when needed): If you must probe, do so in maintenance windows with vendor-approved tools and rate limits. Document the testing in your validation plan.

· Connectors for IT systems: Integrate data from AD, virtualization, EDR (where present), CMDB, and ticketing to enrich the OT inventory with users, VM hosts, and service context.

· Lab instruments: Work with QC to inventory instrument controllers, data systems, and data transfer paths. Many run legacy OS and require special handling.

Design the inventory data model

At minimum, capture:

· Identity: Hostname, MAC, IP, serial number, vendor, model, role (e.g., HMI, PLC, historian server, lab workstation).

· Location/Topology: Site, building, cleanroom/class, production line, cabinet, Purdue level, zone/conduit.

· Software/Firmware: Version, patch level, signatures/WHL, approved baseline.

· Connectivity: Protocols, open services/ports, peer communications (source/destination/interval).

· Criticality: GxP relevance, safety impact, batch-critical flag, RTO/RPO.

· Ownership & Support: Business owner, technical owner, vendor contact, maintenance contract, support status (EoL/EoS).

· Security & Integrity: Hardening status, AV/allow-listing/EDR status (if applicable), backups, last config change, last validation date, audit trail linkage.

· SBOM (where possible): Component libraries for software-based assets and appliance images.

Build the source of truth (SoT)

· Choose the system: OT-aware asset management platform or CMDB with OT extensions.

· Automate enrichment: Ingest from passive sensors, switches, firewalls, virtualization, and vendor CM tools. Reconcile duplicates and flag conflicts.

· Versioning and audit: Every update to the inventory is versioned; changes are traceable to a person/process and linked to MOC records.

Map zones, conduits, and data flows

· Translate inventory to architecture: Group assets into zones (e.g., Cleanroom Control, Purified Water, Sterile Fill Line DCS, Utility BMS, QA/QC Lab) and conduits (firewalled paths, jump hosts, data diodes).

· Baseline expected communications: Whitelist normal talk paths (HMI→PLC, PLC→Historian, Historian→MES/LIMS).

· Visualize dependencies: Include upstream services (AD, time servers, backup, NTP/PTP) and offsite links (remote support, serialization provider).

Validate and integrate with quality systems

· Validation package: Risk-based validation for the visibility tooling and data flows, aligning with Annex 11/Part 11 expectations.

· SOPs and work instructions: How to add assets, decommission assets, reconcile changes, and review reports, owned jointly by Engineering, QA, and Cyber.

· Training: Ensure engineers, QA, and operators understand the inventory process and where to find asset information during deviations or incidents.

Continuous monitoring and drift detection

· Change detection: Alert on new devices, firmware changes, new services, or unusual protocols. Route alerts into your OT SOC or site security team.

· Vulnerability context: Map firmware/OS versions to CVEs with OT-aware risk scoring. For validated systems, pair with compensating controls and documented risk acceptance.

· Behavior analytics: Use protocol-aware detection to flag out-of-policy commands (e.g., STOP/START, write operations) or unexpected lateral movement.

Secure remote access and third-party controls

· Brokered access: Enforce vendor access through dedicated gateways with MFA, session recording, and time-bound approvals.

· Identity hygiene: No shared vendor accounts; tie sessions to individuals.

· Non-persistent jump hosts: Reset to baseline between sessions; never allow direct access to Level 1/2 assets.

· Inventory hooks: Every remote session updates asset “last accessed” metadata for audit.

Lifecycle management and decommissioning

· EoL/EoS strategy: Flag aging PLCs, HMIs, and Windows boxes; plan migrations with validation impacts and spare parts.

· Golden images and backups: Maintain validated baselines (images/config archives) for rapid rebuilds.

· Secure disposal: Data-bearing components sanitized with certificates of destruction; remove from inventory with MOC closure.

Metrics and governance

Track KPIs that prove both coverage and control:

· Inventory coverage: % of OT/Lab/Utility assets discovered vs. estimated baseline

· Accuracy: % assets with current firmware/owner/criticality

· Drift MTTR: Median time to reconcile unauthorized changes

· Vulnerability context: % of critical assets with known version state

· Remote access discipline: % sessions brokered, recorded, and reviewed

· Audit readiness: Time to produce a full asset list with data flows for an inspector

Practical tips for pharma deployments

· Start where risk is concentrated.
Prioritize sterile filling, biologics suites, and utilities sustaining cleanrooms (BMS/HVAC, WFI). The impact of downtime or quality drift is highest here.

· Pair visibility with segmentation quick wins.
Use inventory outputs to implement or refine cell/zone firewalls and enforce minimal conduits. Even simple allow-listing of historian flows reduces attack surface.

· Respect validation with a “no surprises” mindset.
Pre-brief QA/Validation on discovery methods. Document test plans, throttle scans, and run in windows. Make the validation team an ally, not an afterthought.

· Treat labs as first-class OT citizens.
Many lab instruments behave like OT: deterministic comms, fragile services, vendor-managed. Include them in the same visibility and change control framework.

· Make QA your champion.
When visibility is framed as protecting data integrity and reducing deviations, it garners strong quality sponsorship, unlocking faster adoption.

· Don’t neglect utilities.
Compressed air, clean steam, and environmental monitoring systems often hide unmanaged assets that can halt production if compromised.

How to avoid the common pitfalls

· Relying solely on spreadsheets.
Static lists rot fast in dynamic, campaign-based environments. Use passive sensors and integrations to keep the inventory evergreen.

· Ignoring vendor laptops and temporary gear.
Register and tag every device, even if onsite for a day. Tie network access to inventory records.

· Scanning first, asking later.
Unauthorized active scans on legacy PLCs or lab instruments can cause process anomalies. Always align with Engineering and QA.

· Treating visibility as a one-time project.
Visibility is a program. Budget for ongoing coverage, updates, and validation re-qualification when tooling changes.

· No linkage to MOC.
If inventory isn’t integrated with change control, drift becomes inevitable, and audit trails crumble.

Bringing it all together: A maturity path

· Level 1 – Baseline discovery (90 days).
Passive discovery in priority areas; create a minimal SoT; identify critical unknowns.

· Level 2 – Governance and validation (3–6 months).
SOPs approved; validation complete; integration with ticketing and identity; drift alerts live.

· Level 3 – Full-plant coverage and segmentation (6–12 months).
Zones/conduits mapped, cell firewalls tuned, remote access brokered; labs onboarded.

· Level 4 – Risk-driven operations (12+ months).
Vulnerability decisions aligned to validation and criticality; KPIs drive continuous improvement; SBOM ingestion for software-heavy assets.

Executive summary for stakeholders

· What: OT asset inventory and visibility provide a live, accurate view of every device, flow, and configuration across production, labs, and utilities.

· Why: It prevents batch loss, accelerates incident response, supports data integrity, and is foundational to IEC 62443/NIS2/GxP compliance.

· How: Start with passive discovery, build a robust SoT, tie it to zones/conduits and MOC, validate the approach with QA, and operate with continuous monitoring and clear KPIs.

· Outcome: A resilient, audit-ready manufacturing environment where cybersecurity enables quality and continuity, not the other way around.