Innovating Life Sciences Solutions

Our primary target market consists of biotech and pharmaceutical companies, with a focus on startups and mid-sized organizations located in San Diego, Los Angeles, and Boston.

We address critical challenges in computer system validation (CSV) by offering innovative strategies and technologies, including:

1. Transitioning from CSV to CSA 

2. Implementing risk-based CSV approaches aligned with modern regulatory expectations.

3. Automating CSV processes through AI-driven solutions, enabling clients to reduce validation cycles by over 50%, which significantly lowers effort and cost.

Many organizations struggle with outdated methods and face obstacles such as:

• Inefficient CSV SOPs that fail to meet current regulatory standards.
• Difficulty transitioning from traditional CSV to CSA methodologies.
• Over-reliance on large volumes of test cases, with no clear risk-based strategies in place.
• Lack of processes to identify regression test suites for cloud software.
• Inadequate tools for gap analysis, traceability, and managing impacted test cases during system upgrades or migrations.
• Poor documentation practices and a shortage of professionals skilled in modern automation tools and AI technologies.
• Non-compliance with evolving regulatory guidelines such as FDA, EMA, and standards like GAMP 5, 2nd Edition.

At EVOLV, we bring unparalleled expertise and proven results, including:

• 100+ successfully executed CSV projects across startups, mid-sized companies, and large pharmaceutical enterprises.
• Demonstrated success in CSV to CSA transitions, achieving up to 50% cost and effort reductions.
• Access to highly skilled CSV professionals trained through our proprietary CSV-GameChanger courses, with over 2,000 professionals trained to date.
• Industry-leading innovation, staying ahead of the curve in automation tools and AI solutions designed for 2025 and beyond.
• Extensive experience with data migration, including seamless transitions to Veeva Vaults (e.g., QMS).
• Expertise across key roles, including Business Lead, CSV Lead, and Data Migration Lead, for major testing/validation lifecycle management tools.
• A steadfast commitment to customer satisfaction, driven by our core values of trust, kindness, and delivering 10x better service every time.

Here’s what sets EVOLV apart:

• Proven Practitioners: We are not just consultants; we have real-world experience delivering modern CSV solutions.
• Highly Skilled Professionals: Through our 7 online courses, we’ve trained and equipped over 2,000 professionals to excel in CSV, CSA, and automation.
• Customer-Centric Focus: We deeply understand the needs of CSV professionals and empower them to deliver exceptional results for clients.
• Raving Testimonials: Our clients consistently praise our ability to deliver high-quality work, on time and without hassle.
• Unmatched Expertise: From risk-based strategies to cutting-edge AI tools, we provide unparalleled solutions tailored to 2025’s CSV requirements.
• Commitment to Excellence: Our mission is to be the #1 provider in our niche, offering a world-class experience to both customers and employees.

By choosing EVOLV, clients gain a trusted partner who is dedicated to their success and committed to delivering transformative results in computer system validation.