Pharmaceuticals EHSQ Software
Pharmaceutical and life sciences organizations partner with Intelex to safeguard employees, product quality, and consumers. With Intelex’s integrated EHS, quality, and sustainability software, organizations can maintain validated, inspection-ready EHSQ processes. Intelex supports compliance across R&D, manufacturing, and supply chains, while enabling controlled innovation and continuous improvement.
- Protect employees and patients through proactive safety and quality risk management
- Support validated EHSQ processes across R&D, manufacturing, and distribution
- Centralize EHS, quality, and compliance within a single, enterprise SaaS platform
- Aligned with compliance regulations, 21 CFR Part 11, GAMP 5, ISO 13485:2016, and global standards
Pharma EHSQ Software Protects Employees, Products, and Patients
Intelex’s EHSQ software for pharmaceuticals and life sciences delivers integrated health, safety, and quality management while simplifying compliance and supporting faster, more reliable product development and manufacturing.
Higher QA/QC Confidence
Quality and EHS teams in pharmaceutical environments need a single source of truth. Disconnected EHS, Quality, and manufacturing systems slow investigations, create compliance gaps, and delay batch release. Intelex connects EHS and Quality workflows within a single system, providing end-to-end traceability for incidents, deviations, investigations, and CAPAs.
Compliance & Regulatory Authority
Pharmaceutical organizations operate under constant regulatory oversight. Intelex’s compliance management software supports adherence to evolving national, local, and regulatory compliance frameworks, including GxP standards.
Manage Sustainability Data
Quality, safety, and governance are deeply interconnected in the pharmaceuticals industry. Intelex Sustainability Software integrates environmental, social, and governance data into a single, auditable system of record, enabling robust operational governance, executive visibility, and informed decisions that support compliance and financial performance.
Streamline Inspections and Auditing Processes
Audits and validations are a core part of operations in pharmaceuticals. Intelex inspection and audit management software centralizes audit planning, execution, and corrective actions within a single system of record. Standardized workflows and documentation support internal audits, supplier audits, and regulatory inspections while aligning with validated system requirements.
Supporting Quality Management Software for Pharma
Intelex partners exclusively with Glemser for quality management system (QMS) validation. This collaboration enables clients to customize Intelex to their specific needs and to become familiar with the system and validation process.
It also provides a reliable foundation for ongoing audit support, system enhancements, and efficient future validations.
Proven EHS Management Software
for Pharmaceutical Companies
Intelex EHSQ Management Software provides an integrated platform to protect employees, ensure product quality, and maintain compliance throughout the product lifecycle.
From research and development through commercial manufacturing and distribution, Intelex helps pharmaceutical organizations streamline processes, reduce risk, and support continuous improvement in highly regulated environments.
Centralize health and safety management across laboratories, manufacturing facilities, and distribution operations to protect employees in controlled and high-risk environments.
Identify, assess, and control quality and operational risks that can impact product integrity, compliance, and patient safety.
Support validated, compliant operations while enabling continuous improvement across EHS and quality processes.
Expand your Knowledge with these Featured Resources
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When EHS and Quality operate on disparate platforms, audit risks and operational issues increase.
The Pharmaceutical Industry's Trusted EHSQ Partner
Get to know our clients and the difference Intelex has made in these utility organizations. Trusted by over 1,400 clients and 1.5 million users worldwide.
"We tend to create tools from scratch, so having the app builder is a big advantage because we can utilize the existing structure of Intelex backed by our own business and operational needs. That is a big plus."
Mikki Teodoro, Global Operations Integrity (OI) Communications and IT
"While we selected the Intelex system to solve some very specific performance issues it turned out to be a culture change instrument as well."
Marsha Parker, Director, Quality and Performance Improvement, Community Memorial Health System
“Intelex has taken our questions and concerns to heart and helped customize systems that work for us.”
Jason Usilton, Quality Supervisor, SDIX
Frequently Asked Questions
Intelex offers a comprehensive suite of EHS capabilities built on an interconnected platform, covering regulatory compliance, hazardous materials, occupational health and safety, and environmental management for pharmaceutical organizations.
- Regulatory compliance: Compliance Tracker manages permits, tasks, assessments, and audits, with regulatory content from Enhesa keeping domestic and cross-border requirements current, all built on the ISO framework.
- Refrigeration compliance: This module includes record-keeping, cylinder inventories, service records, leak rate calculations, and equipment inventories, which are important for organizations managing temperature-sensitive products.
- Hazardous materials and SDS management: Integrates with content providers like 3E. This integration allows you to pull in SDS information, manage new SDS approvals, and access multi-language SDS. Intelex also supports features like QR codes for quick scanning and retrieval of SDS documents.
- Occupational health and safety: Includes incident management, observations, risk assessments, and job safety analysis/job hazard analysis, mobile-enabled inspections and audits, and training management.
The platform is highly configurable to your terminology and workflows, with native mobile apps for offline data capture and fully interconnected data across all modules.
Intelex's ESG Corporate Reporting application helps pharmaceutical organizations collect and report Scope 1, 2, and 3 emissions data on the same platform used for EHS and quality management. This centralizes sustainability data with safety, quality, and compliance records instead of managing it separately.
The application aligns with evolving regulations and frameworks like CSRD, GRI, and CDP, helping pharmaceutical organizations keep pace as ESG reporting requirements and their environmental footprint change. Environmental incidents, such as chemical spills and releases, are tracked separately and can inform broader environmental reporting when relevant.
Intelex's digital QMS is an integrated suite designed for pharmaceutical regulatory and operational demands. Core components include document control, training management, CAPA and non-conformance reporting, management of change (MOC), and audit and inspection tools.
- Document control: Manages SOPs, policies, and validation protocols with version control, approval workflows, and a complete audit trail.
- Training management: Tracks employee training and certifications, linked to documents for automated training matrices.
- CAPA and non-conformance: Identifies root causes and tracks corrective and preventive actions for continuous improvement.
- Management of change: Controls and documents changes to processes, equipment, and documents in regulated environments.
- Audits and inspections: Manages findings and tracks compliance readiness for regulatory inspections.
All applications run on a single interconnected platform for consistent data and reporting, aligned with GMP, ISO 9001, ICH guidance, and GxP principles. The system is highly configurable to your terminology and workflows. Validation support is available through partners like Glemser for 21 CFR Part 11 and GAMP 4/5 compliance.
Intelex supports GxP and FDA software validation through a configurable platform and third-party validation expertise. Intelex partners with specialized providers like Glemser to conduct the validation process required for pharmaceutical regulations.
The platform aligns with 21 CFR Part 11 for electronic records and signatures, and validation typically follows GAMP 4 or GAMP 5 guidelines for automated systems. The underlying QMS also supports GMP and ISO 9001, with enhancements for ICH guidance.
Intelex partners with providers like Enhesa to maintain and update a vast library of domestic and international regulations, integrated directly into the Intelex compliance module. This gives pharmaceutical organizations access to current regulatory content without manually tracking changes.
The platform is also continuously updated to address evolving requirements, with updates and new features prioritized based on customer needs and shifts in the regulatory landscape, particularly for large customers in highly regulated industries like pharmaceuticals.
Intelex supports clinical trials mainly through its QMS and compliance capabilities, aligned with GMP, ISO 9001, and enhanced pharmaceutical-specific standards and International Council of Harmonisation (ICH) guidance. These are foundational requirements for managing clinical trial quality.
Document control manages SOPs, policies, and validation protocols with full traceability for audit trails. Training management ensures personnel involved in trials are properly trained, with records tracked and maintained. The Compliance Tracker module manages compliance tasks, assessments, and audits. Regulatory content from partners like Enhesa keeps trials aligned with current requirements.
The platform is scalable, supporting organizations from early-stage (Phase One) trials through full biopharma operations. Intelex integrates with existing HR systems to manage personnel data as teams grow. Validation support is available through specialized partners to help meet standards like 21 CFR Part 11 and GAMP.
Transform Pharmaceutical Safety and Compliance with Intelex
Experience firsthand how Intelex EHSQ software helps pharmaceutical and life sciences organizations protect employees, ensure product quality, and maintain regulatory compliance.
Whether you’re preparing for FDA inspections, managing CAPAs, supporting system validation, or improving visibility across EHS and quality programs, Intelex provides a trusted platform for regulated environments.
Schedule a personalized demo to see:
- How our platform supports validated EHSQ and quality management processes
- Real-world examples from pharmaceutical and life sciences organizations
- Configurable workflows aligned with FDA and ISO requirements
- Integration options with ERP, LIMS, QMS, and enterprise systems