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Computer System (GxP) Validation Consulting

Management

Quality Assurance

Quality Assurance

Our Management Consulting services with extensive pharma experience help clients to organize, plan, and execute GxP projects while working within restraints like budgets and schedules. Our project managers lead entire team, define project goals, communicate with stakeholders, and see a project through its closure. 

 



We work with you to identify areas of improvement, streamline processes, implement change to optimize your projects, and help you run them more efficiently. 

Quality Assurance

Quality Assurance

Quality Assurance

With years of combined experience in FDA-regulated industries, our team of Quality Consultants offers expert, trusted recommendations to drive compliance and quality.

Where We’ve Made an Impact:

  • Quality Assurance Policies & Manuals
  • Change Control (Deviations/CAPA), Vendor Auditing, and Quality Systems
  • Quality Risk Assessment & Management
  • Validation/Gap Assessments & Remediations
  • Document Control Systems & Training Modules
  • Third-Party Audits & Reporting
  • Vendor Audits

Validation

Quality Assurance

Data Integrity Compliance

We provide comprehensive support for Computer System (GxP) Validation, guiding clients through vendor assessments, requirements gathering, system implementation, and audit support, all in compliance with FDA guidelines. Key areas of expertise include:

  • IT Infrastructure Qualification
  • IT Management Processes & Procedures
  • Validation of Cloud-Based Systems (IaaS, SaaS, PaaS)
  • Periodic GxP System Reviews
  • Data Integrity Audits/ Remediation Plans
  • Complex GxP Data Migration Projects
  • Business Continuity & Disaster Recovery Plans
  • Standard Operating Procedures

Data Integrity Compliance

Data Integrity Compliance

Data Integrity Compliance

 Protecting data integrity enhances stability, performance, and reliability. When data is secure, it remains complete and accurate, regardless of how long it's stored or accessed. The importance of maintaining data integrity cannot be overstated. 

Risk Management

Data Integrity Compliance

Digital Transformation

Our Risk Management Consulting services help identify and mitigate business risks. We work with you to develop a risk management plan that fits your business needs and helps you protect your business from potential compliance risks and cyber threats.

Digital Transformation

Data Integrity Compliance

Digital Transformation

Our Training Consulting services 

 help you make your own Experts in training user community. Our training expert will help create engaging content and develop material to drive engagement and conversions. 


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