Digital Validation for GxP Applications
Our technology-enabled ValiGenius™ is cost-effective, scalable and flexible, offering rapid validation services that minimize the time-to-market for new products and services. Our automated validation process for SaaS applications ensures accuracy and reliability of data production. Continuous support is provided for software validation, including updates, upgrades and re-validation as needed. This ensures ongoing regulatory compliance and reduced risk of data loss and security breaches in SaaS applications used in GXP.
Computer system validation for SaaS applications in GXP (Good Laboratory Practice, Good Manufacturing Practice, and Good Clinical Practice) is a critical component for businesses in regulated industries such as pharmaceuticals, medical devices, and biotechnology. SaaS applications are becoming increasingly popular in these industries, but they must meet the same regulatory requirements as traditional on-premise software.
We understand the complexities of validating SaaS applications used in GXP, and our team of experts is here to help. We offer comprehensive validation services that cover software functionality, data integrity, security, and system performance in accordance with GAMP 5.0 guidelines
Our team will work with you to ensure that your SaaS applications meet regulatory requirements and function as intended. By leveraging our expertise in GXP regulations and validation processes, you can have confidence that your applications are compliant and secure.
Don't let the validation process become a burden on your business. Let Acumen be your partner in ensuring the validation of your SaaS applications used in GXP according to GAMP 5.0 guidelines.
- Transformation of Manual Validation Processes
- Reduces validation time & costs by more than 50%
- Improved data accuracy and compliance for GxP, FDA 21 CFR Part 11, 211, 820 & EU Annex 11
- Improves efficiency and auditability
Patent Pending ValiGenius™
Nearly 100% Automated
Our nearly 100% automated solution significantly reduces validation time and drain on resources freeing up your workforce to focus on core business activities. This allows you to stay in sync with releases more easily, take advantage of improvements within releases and reduce training needs that occur when there are large gaps between upgrades all while maintaining compliance with regulatory requirements such as 21 CFR Part 11 and Annex 11 of the EU GMP guidelines.
Project Based or Managed Validation Services
Measurable benefits of our Managed Service Offering for SaaS software used in GxP companies include:
- Reduced validation time and costs: Our nearly 100% automated validation process can significantly reduce the time and costs associated with validation, allowing for faster time-to-market and increased revenue.
- Improved data accuracy and regulatory compliance: Our Validation as a Service ensures accurate and reliable data production that is compliant with regulatory requirements, reducing the risk of penalties and damage to your company's reputation.
- Reduced risk of data loss or security breaches: Our service helps keep your software up-to-date, minimizing the risk of data loss or security breaches.
- Improved efficiency and auditability: Automation and streamlined auditing processes can improve efficiency and provide documentation to demonstrate compliance, leading to increased productivity and better business outcomes
Our Managed Service Offering eliminates staff/skill gaps and challenges, ensures compliance, improves quality assurance, enhances decision-making, minimizes risk, and provides other measurable benefits. The actual values will vary based on your company's specific circumstances.
Learn how Acumen can help you with your Digital Validation needs.