Implementation & Validation

As your implementation partner, GxP Partners becomes an extension of your IT department with expertise in FDA-regulated and compliance-driven environments. We've led many successful systems and software implementations, from single-site installations to large-scale global rollouts. Our first order of business is understanding your requirements. We're then able to address your implementation needs quickly and cost effectively by offering services in:
  • Project Management
  • Software Installation
  • Systems and Data Migration
  • Custom Interfaces
  • Validation 
  • Applications Training

GxP Partners provides the vital expertise, tools, and resources you need to install, integrate, or upgrade your existing system. During the software selection process, we lead your team through a proven process to identify the right software solution. Through our strategic partnerships, we offer a full portfolio of software offerings for quality & compliance management as well as enterprise content management. We also have an extensive history implementing other leading software solutions in these categories and can provide the services support you require regardless of the solution you choose. 

GxP Partners offers a start-to-finish solution for validating a computer system following GAMP (Good Automated Manufacturing Practice). Our computer system validation methodology offers everything you need, including policies and easy-to-use templates that guide you through the process from planning to "go live." Now you can guarantee regulatory compliance and optimal system performance at a reasonable cost...and quickly generate all required documents in the process. The GxP Partners methodology gives you direct access to our years of experience validating computer systems that comply with requirements of ISO, cGMPs, QSR, EMEA, 21 CFR Part 11, HIPAA, Sarbanes-Oxley, and other regulations.
 
About GxP Partners Implementation & Validation Services  (PDF, 90 KB)
 
Compliance Consulting & Quality Auditing      
 
 
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