Validation Services

System validation and lifecycle services for the Life Sciences industry.

Manufacturing IT, automation, and process control systems must be validated to be in compliance with current GxP and FDA regulations.

Our system lifecycle and validation services enable the commissioning and qualification of your computerized systems through well-established methodologies that simultaneously meet regulatory compliance requirements and mitigates risk.

Services

Control Associates has significant experience working with GxP and ICH guidelines. We understand the regulatory context and are driven by the desire to implement pragmatic approaches that meet compliance requirements. Our processes comply with all categories of GAMP® guidelines and are able to perform the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). Ensuring accurate and reliable data is critical to maintaining loss/gain allowances and avoiding compliance and contractual issues, including risk-based methodologies.

GAMP 5
GAMP for MES
ASTM E2500-07
ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems and Equipment

Budgetary Estimates
Supplier Assessments and Audits
Project Execution Strategic Planning
Validation Master Plan Development
Criticality, Data Integrity, and Risk Assessments
Requirements Development

Specification Development
In-process Supplier Audits
Code Review
Standard Operating Procedures Development

Commissioning, Qualification, Verification Protocol Development and Execution
Traceability Matrices
Project Reports

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(201) 934-9200

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