THE COMPLEXITY OF GxP ENVIRONMENTS
Why pharmaceutical production requires controlled remote access
Pharmaceutical manufacturing is built on validated batch processes controlled through PLCs, SCADA, and MES systems. From process equipment and skids to filling and packaging lines, every interaction with production systems must be controlled and traceable.
But when connectivity relies on VPNs, shared credentials, or ad hoc tools, control weakens, and traceability is lost. In a GxP environment, that introduces compliance risk.
Validated systems require attributable access, not IT-style security
Pharmaceutical production systems must remain in a validated state, and all interactions must be documented and controlled. Agent-based or IT-centric security approaches can impact system integrity or require revalidation, limiting how safely remote access can be implemented in regulated environments.
Vendor access must align with QA and change control processes
Industrial sites depend on ongoing remote support from machine builders, integrators, and maintenance partners.
Without structured governance, access can occur outside QA oversight, making it difficult to align with deviation management and change control procedures.
Data integrity depends on full traceability of system access
Pharmaceutical manufacturing relies on data integrity principles such as ALCOA+. Unstructured remote access can bypass validation boundaries, break traceability, and introduce undocumented system interactions or gaps in accountability.
AGGRAVATED BY COMPLIANCE DEMANDS
Remote access that supports compliance and data integrity requirements
Pharmaceutical manufacturing environments are governed by strict requirements for validated systems, controlled access, and data integrity. Structured OT secure remote access provides the technical foundation for enforcing these requirements across OT environments.
GxP AND DATA INTEGRITY (ALCOA+) REQUIREMENTS
GxP frameworks require that all activities affecting production systems are controlled, documented, and attributable.
Guidance from global authorities such as PIC/S and MHRA reinforces the importance of secure, traceable access to computerized systems.
OT secure remote access supports these expectations by:
- Enforcing unique user identification and authentication
- Maintaining complete, time-stamped records of system access
- Preventing uncontrolled or shared access to production systems
This ensures remote access aligns with global data integrity expectations.
EU GMP ANNEX 11 – ACCESS CONTROL FOR COMPUTERIZED SYSTEMS
Annex 11 requires that computerized systems be secure, access-controlled, and fully traceable.
OT secure remote access supports Annex 11 by:
- Restricting access to authorized users and defined systems only
- Enforcing role-based and time-limited permissions
- Providing complete traceability of remote access sessions
This ensures that remote access does not compromise validated system boundaries.
FDA 21 CFR PART 11 – CONTROLLED ACCESS TO REGULATED SYSTEMS
FDA 21 CFR Part 11 requires that access to systems managing electronic records is secure, controlled, and attributable.
While Part 11 primarily applies to data systems, remote access must not introduce uncontrolled entry points.
OT secure remote access supports these expectations by:
- Ensuring only authorized users can access production systems
- Providing traceability of all remote sessions interacting with regulated systems
- Eliminating shared or unmanaged access paths
This helps maintain the integrity of systems governed by Part 11.
NIS2 & CYBERSECURITY OBLIGATIONS (EU)
Under NIS2, pharmaceutical manufacturers must implement cybersecurity risk management measures across OT environments.
OT secure remote access supports these requirements by:
- Enforcing identity-based access control for all remote users
- Providing continuous monitoring and logging of access activity
- Supporting incident investigation through full session traceability
IEC 62443 – SECURING OT ENVIRONMENTS
IEC 62443 defines best practices for securing industrial control systems used in production environments.
OT secure remote access aligns with these principles by:
- Enforcing asset-level access instead of flat network connectivity
- Limiting external access to specific production systems
- Providing centralized visibility and logging of remote activity
This strengthens OT cybersecurity without impacting performance or validation.
OPERATIONAL SAFETY IN HIGH-RISK ENVIRONMENTS
Pharmaceutical facilities handling hazardous substances, such as active pharmaceutical ingredients (APIs) and chemical processes, may also be subject to safety frameworks such as Seveso (EU), COMAH (UK), PSM (US), and RMP (US).
While these frameworks focus on process safety, they depend on controlled and reliable operation of production systems.
OT secure remote access supports these environments by:
Restricting access to authorized users and defined systems
Ensuring full visibility of remote activity
Reducing the risk of unintended or unsafe interaction with production processes
Practical remote access use cases in pharmaceutical OT environments
Secomea’s Secure Remote Access solution can be seamlessly deployed across PLCs, SCADA, and MES systems, batch processing equipment, filling lines, and packaging systems in production sites – regardless of system age or vendor.
Controlled access to validated production systems
Time-limited, role-based access can be granted to defined machines or zones – ensuring validation boundaries are respected and maintained.
Secure vendor access aligned with QA processes
Engineers and external partners can diagnose and resolve issues quickly, reducing mean-time-to-repair while maintaining alignment with internal procedures.
Centralized governance across multiple plants
User management, policies, and session logs are centralized and consistent, while enforcement remains local within each facility.
Full session traceability for audits and inspections
All remote access sessions are tracked, logged, and recorded – supporting GxP compliance, FDA and EMA inspections, and internal QA audits.
Keep validated systems intact while enabling remote support
Pharmaceutical production requires both control and responsiveness.
Secomea’s OT Secure Remote Access enables:
- Faster resolution of production issues
- Controlled vendor intervention
- Protection of validated systems
- Full traceability of all remote access activity
HERE'S HOW WE DO IT AT SECOMEA
OT-native access architecture for validated production
Across pharmaceutical regulations, the requirement is clear: access to production systems must be controlled, attributable, and audit-ready.
OT secure remote access provides the technical foundation for meeting that expectation. Secomea supports regulated environments with:
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Asset-level access instead of full network exposure
Access is granted to defined systems or lines – preventing lateral movement across production zones and ensuring validation boundaries are not crossed. -
Centralized governance with plant-level enforcement
Users, permissions, and logging are managed centrally in the cloud, while access is enforced on-site through the SiteManager. This ensures consistent policy enforcement across sites without relying on complex VPN infrastructure. -
Production-safe and validation-friendly deployment
No agents on production systems. No modification of control logic. No disruption to validated environments. Secomea integrates with your existing infrastructure without requiring architectural redesign.
Trusted across 8,000+ regulated manufacturing environments globally
Purpose-built for Cyber-Physical Systems (CPS)
Designed for validation and compliance
Lowest TCO in the industry
Built for OT. Trusted by IT.
What they say about us
Read why global pharmaceutical manufacturers chose Secomea to secure their remote access operations around the world.
Scaling SRA across pharma production sites
Global Pharma Manufacturer
Case Study
Enabling validated, audit-ready OT remote access
Global Pharma Manufacturer
Case Study
Take control of remote access in your plants
See how structured, audit-ready OT secure remote access supports compliance, protects validated systems, and enables secure remote support.
Book a meeting to:
- Explore how Secomea fits your production environment
- Review architecture and deployment options
- Discuss compliance and third-party access requirements
- Get all your questions answered
Frequently asked questions
What is secure remote access in pharmaceutical manufacturing?
It is identity-based, controlled access to production systems ensuring all activity is attributable, traceable, and compliant.
How does it support GxP and data integrity requirements?
It ensures all system access is controlled, documented, and attributable, supporting validation and ALCOA+ principles.
Can remote access be used in validated systems?
Yes. It can be implemented without modifying control logic or affecting system validation.
How does it support Annex 11 and FDA requirements?
By ensuring secure, controlled, and traceable access to systems, supporting electronic records and computerized system requirements.
How is this different from VPN access?
VPNs provide broad, uncontrolled access. OT secure remote access enforces asset-level control with full traceability.
Can vendor access be controlled and audited?
Yes. Access is approved, time-limited, role-based, and fully traceable.