IS YOUR ORGANIZATION CHALLENGED BY…

  • Centralized vs. Decentralized Validation Governance
  • Computer Systems Validation processes
  • Multiple processes and requirement interpretations
  • Program teams recreating the wheel for every project vs. consistent streamlined processes
  • Just-in-time deployment of resources (the right place at the right time)
  • A lack of risk-based processes that drive reduction of overall effort and target issues
  • Technology adoption avoidance due to validation requirements
  • Compliance issues and remediation efforts
  • Rework
  • Increased cycle time
  • Data integrity issues
  • Team integration issues
  • A lack of procedures and processes
  • The inability to scale resources to support Computer Systems Validation
  • Trying to implement and utilize best practices
Medical Device Computer System & Global Validation Governance

ENGILIFESCIENCES PROVIDES COMPREHENSIVE SOLUTIONS THAT DRIVE FASTER, LEANER AND EFFECTIVE COMPLIANCE WHILE REDUCING OVERALL COSTS.

SERVICES INCLUDE

Global Harmonization for Computer Systems Validation – we work with the various groups across a global enterprise to harmonize processes that drive a centralized vs. decentralized governance approach to reduce overhead across the organization.

VALIDATION GOVERNANCE

Centralized Validation Governance
Decentralized Validation Governance
Optimization Assessments

OPTIMIZATION ASSESSMENTS

Identifies opportunities to optimize and implement processes that eliminate non-value-added activities, as a result, overall cycle time is reduced.

Compliance Risk Assessments

COMPLIANCE RISK ASSESSMENTS

Identifies potential areas of compliance risk within the Computer Systems Validation processes.

Computer Systems Validation Remediation Services

COMPUTER SYSTEMS VALIDATION REMEDIATION SERVICES

Remediate and implement compliant software systems and processes.

Managed Services For Computer Systems Validation

MANAGED SERVICES FOR COMPUTER SYSTEMS VALIDATION

Assists clients in managing the day-to-day activities for Computer Systems Validation. Our team works with our clients to manage, perform and maintain Computer Systems Validation.

Computer Systems Validation

COMPUTER SYSTEMS VALIDATION

Provides staff augmentation services to assist with scaling resources based on the client’s needs.

Download Your CSV Guide today!

EngiLifeSciences’s CSV Guide | Uncommon strategies that streamline the process and reduce costs.

What if you could save 25-30% of your computer validation costs and adopt technology at a faster rate? Download your free booklet today and uncover the barriers and strategies that will streamline your Computer System Validation (CSV) Process.

*By clicking the Submit button you agree to opt into EngiLifeSciences email communications.

Outcomes | Goals |  Processes

Manage and navigate the global regulatory compliance landscape

Reduce overall costs

Increase efficiency and utilization factors

Maintain compliance and sustainability

Manage and utilize software validation best practices