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Compliance + Validation 2017-10-26T18:34:46+00:00

Let Vantage keep regulatory compliance of your equipment, systems and facilities simple and cost effective. Our cGMP engineering & technical staff has experience in regulatory compliance back to inception of validation regulations in the 1970s – with several helping to develop them. Our regulatory compliance and validation services include preliminary and conceptual design review; validation strategy master planning; validation protocol development & execution, computer system and automation validation; utility and equipment validation; ERP system validation, and commissioning activities.

Our proprietary methodologies optimize commissioning & validation phases to keep projects on schedule & under budget.

Areas we have successfully addressed include:

Preliminary & Conceptual Design Review
Detailed Design Review
IQ, OQ, & PQ Development
MP Review, Audits, & Remediation
Validation Master Planning
GAP Analysis & Risk Assessments
System & Automation Validation
Utility & Equipment Qualification
System Quality Assurance Plans (SQAP)
ERP (e.g. SAP R/3) System Validation
Cleaning Validation
FDA Liaison & Presentations
URS, FRS & DDS Development
Commissioning Activities

CUSTOMER BRIEFS

Developed, Implemented & Tracked a Successful Validation Strategy

Vantage was engaged by a major pharmaceutical company that was implementing a serialization project on two packaging lines. The customer lacked the resources to develop and execute the validation strategy. Our team was not only experienced in developing validation master plans and IQ/OQ/PQ protocols, we also had subject expertise in qualifying a serialization solution. We ensured that all the documentation was developed, including a traceability matrix, worked closely with the solution providers, executed all the protocols and authored the final summary reports – all ahead of the original schedule.

Our Additional Services

STRATEGIC GUIDANCE

AUTOMATION

SERIALIZATION

From raw material handling to product distribution and logistics, our technical consultants augment your project team, or our project management professionals can handle all aspects of your project.

Our automation and systems staff consists of engineers with 20-30 years of industry experience in diverse automation systems. We’ll help you through all aspects of project execution from planning to market.

Vantage Consulting helps our customers examine the immediate cost benefits of product serialization and product tracking through their specific manufacturing and distribution processes.