Healthcare and Pharmaceuticals 

Material Intelligence for Regulated, Quality-Critical Operations

For the healthcare and pharmaceutical industries, all material decisions can affect patient safety, regulatory compliance, and product quality. Data on APIs, excipients, equipment, utilities, and MROs needs to be accurate, traceable, compliant, and reusable with little or no negative effect on your workflow.

IEHUB adds an intelligent governance layer, which eliminates duplication, maintains compliance, and ensures ERP integrity. As a result, you reduce expensive mistakes and increase the speed of controlled execution within regulated industries. 

The Reality of the Industry 

Health care and pharmaceutical companies are confronted with the following: 
Ongoing and stringent compliance with regulatory requirements (FDA, EMA, GMP, and GxP, etc.) 
Extensive documentation and high audit requirements 
Prolonged life cycles for products and their associated asset value 
Numerous manufacturing locations and contract manufacturing organizations 
Substantial costs associated with product-related errors, recalls, and deviations. 

Yet material data is often

The Risks of Ineffective Materials Control 

When materials are created without a full intelligence
The creation and entry of duplicate items into an Enterprise Resource
Planning (ERP) System
The potential to overlook any Approved Item Equivalents  

The lack of supporting documents, or access to those documents

The loss of engineering
justification
The increased complexity of Auditing and the Increased Risk of a failed Audit
The result is non-compliance, increased cost.

The IEHUB Approach 

IEHUB implements an intelligence control layer before the creation of ERP materials. 

Healthcare and pharmaceutical organizations can proactively:

Document structured material requests

Associate specifications, datasheets, and validation documentation
Identify duplicates and like materials

Document structured material requests

Administer approvals with full traceability

The ERP continues to be an authoritative source of information.

IEHUB’s objective is to provide only with compliant and validated items to the ERP. 

How IEHUB is a Resource for Healthcare &
Pharma Teams 

Maintain Compliance & Audit Readiness 
  • Full Approval Trails
  • Link Technical and Compliance Documents
  • Provide a Clear Rationale for Creating Material
  • Easier Inspection and Audits
Speed Up Change Without Risk 
  • Maintenance Requirements
  • Capacity Expansion
  • Order Changes
  • Supplier Substitution
Maintain ERP Data Quality 
  • Minimal Redundant Records
  • Improved Master Data Governance
  • Minimal Lifecycle Management

Business Benefits

Reduced risk of non-compliance

Decisions are traceable, have justification, and can be audited. 

More materials available more quickly

Teams are able to identify approved materials instead of creating them again. 

Increased operations efficiency

Cleaner data will improve planning, purchasing, and executing methods. 

Decreased effort for validation

Approved items can be reused instead of going back through the qualification process. 

Purpose Built for Regulated Environments

Pharmaceutical Manufacturing Plants 
API and Formulation Facilities
Medical Device Manufacturing Plants
Biotech and Life Science Activities
Multi-Facility, Regulated Supply Chains 
Where the governance of materials has a direct influence on:
Patient Safety 
Regulatory Compliance 
Business Continuity 

Architecture Principle

Separation of these processes ensures the speed of process execution with full control of the operations. 

Ready to make every material decision audit-ready and reusable?

Healthcare and pharmaceutical organizations require confidence in their material decisions, not additional systems.

IEHUB offers intelligence, traceability, and governance in these decisions before entering ERP, allowing teams governed by regulations to act quicker without sacrificing compliance. 

Hontrel is a digital engineering and technology company focused on continuously applying advanced technologies in the core engineering space and re-thinking the conventional methods of engineering to bring innovative and sustainable solutions which adds value to our customers, stakeholders and ultimately improving the human experience.
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