Validation

At EXL Laboratories, Inc. we pride ourselves in offering complete validation services compliant with FDA and EU regulations. Our validation services include strategic planning based on current risk base approach for validation, commissioning and qualification activities. We have experts in regulatory compliance who understand FDA, EU, ICH, sFDA and PICS requirements.

 

Whether you are a highly experienced organization looking for skilled resources to supplement your own staff or you are a company looking for specific expertise in an area new to you, EXL Laboratories, Inc. can assist you. Our experienced staff can help you prepare for a pre-approval inspection, bring new facilities on line, bring products to commercial market, and meet your commitments to the regulators.

 

We offer a full range of validation services including the following:
* Validation Master Plans
* Validation Protocols / Reports / Field Execution
* Analytical Instrument Qualification
* Computerized System, IT Infrastructure and Software Validation
* Cleaning Cycle Development and Validation
* Factory Acceptance Testing
* Site Acceptance Testing
* Equipment Qualification
* Facility Qualification
* Process Validation
* Utility System Validation
* Aseptic Process Validation
* Shipping and Packaging Validation
* Test Method Validation