Our Services

Services

Compliance Management

Accelerated Plant Startup
Audit Support/Response

FDA Remediation
483 Resolution

Merger & Acquisition Integration
Consent Decree Leadership

Validation

Accelerated Process Validation
Operational Qualification
Mold Qualification
First Article Inspection
Keyence Validation

Accelerated Design Validation
Tool & Fixture Qualification
Material Qualification
Test Method Validation
Data Validation

Accelerated Product Validation
Installation Qualification
Performance Qualification
Software Validation
Cleaning Validation

Supplier Support

Receiving Inspection Support
Supplier Management SQMS
Supplier Data Analysis

Supplier Audits
Supplier Corrective Actions
Supplier Scorecards

Supplier Process Qualification
Supplier Qualification

Statistical Support

Validation & Operational Statistics
Correlation Studies

Failure Mode Effect Analysis
Characterization Studies

Critical Control Point Administration

Quality Management System

Corrective/Preventative Actions
Data Integrity
Non-Compliance Reports
RI Router Creation/Update

Process Capabilities Analysis
Product Data Management
Engineering Change Requests
SOP Creation & Audit

Regulatory Compliance
Compliance Auditing
Calibration Administration

Design Validation

Risk Management Assessment

Design Control

Design Assurance

Data Services

Systems We Support

We provide end-to-end Validation, Data Migration & Data Testing on systems such as:

Veeva Vault
Wonderware BMS
JD Edwards
JIRA
Siemens MES
Ignite
Proprietary DMS

Trackwise
Wonderware SCADA
SAP ERP
DeltaV
FTAC
Agile

Labware LIMS
SCADA
Tracelink
Documentum
ServiceNow
Proprietary QMS

ITECompliance is a division of Integrated Technology Edge Corporation