- 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
- 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
ENGILIFESCIENCES PROVIDES COMPREHENSIVE SOLUTIONS THAT DRIVE FASTER, LEANER AND EFFECTIVE COMPLIANCE WHILE REDUCING OVERALL COSTS.
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.
Identiﬁes opportunities to optimize and implement processes that eliminate non-value-added activities, as a result, overall cycle time is reduced.
COMPLIANCE RISK ASSESSMENTS
Identiﬁes potential areas of compliance risk within the Computer Systems Validation processes.
COMPUTER SYSTEMS VALIDATION REMEDIATION SERVICES
Remediate and implement compliant software systems and processes.
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
Provides staff augmentation services to assist with scaling resources based on the client’s needs.
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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.
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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