EREN Corporation
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EREN Corporation - Computer & Engineering Services - Validation:

API and Finished Pharmaceutical Manufacturing

GMP Audit of Facilities & Operations

HPLC Analysis

Environmental Control Monitoring Systems

Aseptic Dry Powder Filling Operations

Sterility Testing

Lab Equipment Qualification

Sterile Processing Equipment Qualification

Manufacturing Equipment Qualification

Process Validation

GMP Training Program Development

QMS Gap Analysis

Process Documentation

Cleaning Qualification

Performance Monitoring Reports

Write policy and procedures

Insure Compliance with Applicable Local and IRB / IEC Requirements

Protocol and SOP Writing and Tracking

Provide training for Investigation & documentation of OOS Events

Document Collection, Review and Maintenance

Identify, Monitor, Document and Track Out-Of- Scope Activities

System Life Cycle Validation Documentation of Computer & Automation Systems

Investigate & Identify Anomalies & Abnormalities – testing including GC, LC, UV AND IR spectrophotometer tests

Host Workshops on Investigation Techniques & Documentation for Manufacturing Atypicals

Write Effective Investigations, Corrective Actions and Preventative Actions to close out Existing Deviations