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
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