Validation & Qualification Services
PROCESS VALIDATION:
Process validation is about proving that your manufacturing processes consistently produce products that meet predetermined quality standards. At Altiveno, we design and execute validation strategies that are scientifically sound, regulatory-compliant, and tailored to your operations.
From protocol development to execution and reporting, we ensure every step is documented and defensible. Our approach not only satisfies regulators but also strengthens your manufacturing reliability, reduces variability, and safeguards patient safety. With Altiveno, process validation becomes a driver of consistency and trust.
CLEANING VALIDATION:
Effective cleaning validation is critical to preventing cross-contamination and ensuring product safety. Altiveno develops robust cleaning validation programs that demonstrate your cleaning procedures are effective, reproducible, and compliant with GMP expectations.
We help you establish scientifically justified acceptance criteria, design sampling strategies, and document results in a way that stands up to regulatory scrutiny. By partnering with Altiveno, you gain assurance that your facilities and equipment are not only clean but verifiably clean—protecting both your products and your reputation.
COMPUTER SYSTEMS VALIDATION:
In today’s digital environment, computer systems are integral to every aspect of pharmaceutical operations. Regulators demand proof that these systems are reliable, secure, and compliant. Altiveno provides comprehensive CSV services that ensure your software and digital platforms meet regulatory requirements such as GxP and 21 CFR Part 11.
We manage the full lifecycle—from risk assessments and validation planning to testing, documentation, and ongoing maintenance. Our CSV approach ensures your systems are not only validated but also optimized for efficiency, data integrity, and long-term compliance.
FACILITY, UTILITY & EQUIPMENT QUALIFICATION:
Facilities, utilities, and equipment form the physical backbone of your operations. Altiveno ensures they are properly qualified to perform as intended, consistently and reliably. Our experts design and execute qualification protocols (IQ, OQ, PQ) that demonstrate compliance with GMP and regulatory expectations.
From HVAC systems and water utilities to critical manufacturing equipment, we provide the assurance that your infrastructure is fit for purpose and inspection-ready. With Altiveno, qualification is not just a regulatory checkbox—it’s a guarantee of operational excellence.
