MethodSense, Inc.
 Practical Regulatory Solutions
Audit Services

Outsourced audit services for Life Science

Audits are a way of life for companies operating under the watchful eye of the U.S. Food & Drug Administration. Unfortunately, many life science companies struggle to manage audit processes without disrupting or detracting from core business operations. The challenge is often created by a lack of qualified, dedicated in-house audit personnel, limiting the quality and increasing the cost of the work.

 

MethodSense fills this gap. Our expertly trained audit professionals become an extension of your company, facilitating audits quickly and effectively while you focus on what you do best – innovation. Whether the audit reviews a vendor, internal operations, or a potential partner, MethodSense provides the assurance you need to confidently drive your business forward.

Standard available audits include:

 

 ·   Title 21 CFR

 ·   cGMP

 ·   ISO 9001:2008

 ·   HIPAA

 ·   GAMP

 ·   GxP

 ·   CMM

 

MethodSense deliverables include:


  ·   Gap Analysis 
  
·   Risk Assessments
 
·   Remediation Strategies