Validation
Improve regulatory compliance with our CSV services. Our team helps you follow the strict validation requirements and adhere to the regulatory guidelines.
About
Our experienced team will find the most effective and cost-efficient validation method for your project, compliant with your existing processes and document the consistency, quality, and accuracy of your systems, methods, and processes.
We understand the different validation requirements for GMP, GLP, and GCP systems and the best ways to ensure compliance with FDA regulations.
Validation Services
- Using a risk-based approach, we help in assessment your system based on:
- GxP Requirements and criticality
- Software category (based on ISPE GAMP® 5)
- Supplier assessments and/or audits System scope complexity
Services Offered:
Planning
- Enterprise validation master plans and supporting procedures
- Validation management.
- Project plan development and implementation
- Regulatory gap analysis and remediation (e.g., 21 CFR Part 11, cGMP, GLP, data integrity)
- System risk assessments
- SOP creation if any
Execution
- We validate all of your software, databases, spreadsheets, and computer systems, and develop the appropriate documentation for all phases of the software life cycle.
Go Live
- Well documented procedures and report generation.
- Migrations tasks if any.
- Handover process and handholding
- Change control
What is Computer System Validation
The FDA defines software validation as: “Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled” – General Principles of Software Validation: Final Guidance for Industry and FDA Staff
We Validate
Our computer software validation expertise includes a wide range of enterprise software applications. Our validation process also addresses procedural controls related to change management, data integrity, and training records. A maintenance program also provides a cost-effective way to stay in compliance.
Its More
Computer validation is more than a compliance requirement. Pharmaceutical computer system validation is a unique opportunity for a business to examine their computer systems to maximize effectiveness and enhance quality.
Let'Talk
Get in Touch. Drop us a message and we shall connect with you to discuss on what you are looking for.
About Us
We offer services right from planning every step of your enterprise’s digital requirements to choosing the right fit of technology which suit your business processes to offering post-deployment support, we help you throughout your journey of digital transformation..
Contact Us
1/3A Pitambar Villa, Kolbad Road, Thane (West) 400601
9819979019
info@arhventurres.com
Scalable, Sustainable & Cost Effective Solutions