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Regulatory Compliance

 

SOP Development

Let's face it - SOP Development can be time consuming!  We provide our clients with an avenue to ensure that all regulations regarding Standard Operating Procedures are fulfilled while limiting impact on staff and laboratory throughput.  For any assay, instrument or infrastructure procedure we will provide SOP's, forms and logs necessary. 

 

Quality Assurance Readiness

If you are getting ready for a regulatory audit or simply want to arrange a friendly audit to determine your strengths and weaknesses - then we can help! 

We provide an third-party inspector knowledgeable in the regulations associated with your facility and provide a two-day audit followed by an extensive written report and checklist.  This service can be offered for GLP and CAP/CLIA compliance.

 

 

 

Assay Implementation & Validation Assistance

Assay Implementation is a special service we offer that can be an add-on to Assay Development projects.  The benefit of this service is that an Embark Team member will walk you through implemention and/or assist with the validation of your assay in your laboratory.  A site visit is included if needed.

 


 Contact us today P: 866.820.8359                                                                                                                                                                     ©2007 Embark Scientific, LLC | All Rights Reserved.