Green Biotec provides a comprehensive array of laboratory compliance services, encompassing instrument and software qualifications (IQOQ, OQ, and RQ) in accordance with USP <1058> analytical instrument qualification (AIQ) standards. Our compliance consulting extends to custom validation services, including computer system validation (CSV) based on GAMP5 (utilizing a risk-based approach and V model) and part/annex 11 compliance (covering electronic records and signatures), serving as a cornerstone for ensuring data integrity.
The Green Biotec CrossLab group has developed an automated compliance solution tailored to support the end-to-end AIQ process seamlessly. Additionally, we offer custom validation services such as computer system validation, audits/assessments, custom procedure writing, and more, ensuring that your laboratory operations adhere to regulatory standards and best practices.
- Network (ACE)
Green Biotec introduces the Automated Compliance Engine (ACE), a cutting-edge, audit-ready, paperless software solution designed for instrument qualification and reporting. With the installation of Network ACE within laboratory networks, deployment is simplified, and alignment with data integrity standards is ensured. Similar to ACE, Network ACE operates independently of your chromatography data systems (CDS), allowing for seamless integration of USP <1058> analytical instrument qualification (AIQ) practices and streamlining audit preparation processes. With ACE software, you can rely on adherence to protocols, consistent calculations, and accurate reporting, ensuring regulatory compliance and operational efficiency
- Compliance consulting
Our CrossLab compliance consulting services prioritize key areas such as computer system validation (CSV) aligned with GAMP5 (utilizing a risk-based approach and V model) and part/annex 11 (pertaining to electronic records and signatures). We also offer audits and assessments tailored to ensure data integrity, along with custom procedure writing services. An example of this is assisting laboratories in adhering to the 2017 USP <1058> for analytical instrument qualification (AIQ).
To expedite the validation process and optimize efficiency, Green Biotec has developed validation starter kits—a comprehensive suite of generic validation documents. These kits are designed to accelerate the validation process, saving both time and resources.
Leverage the global compliance expertise of Green Biotec CrossLab to empower your lab to focus on scientific endeavors and enhance core productivity.
- Computer system validation
CrossLab’s computer system validation (CSV) serves as the cornerstone for ensuring data integrity compliance, a primary focus of regulatory audits and FDA warning letters. Our experts specialize in assessing overall risk, streamlining validation efforts by prioritizing high-risk areas, and ensuring compliance with regulatory guidelines and standards.
Validation is a lifecycle process encompassing new system commissioning, change control for system upgrades or relocations, and decommissioning systems for archival purposes. Green Biotec supports your laboratory at every stage of this process with our comprehensive CSV services. Partner with us for efficient and cost-effective validation solutions.
- Validation Start Up Kit
The lab validation starter kit offers a comprehensive collection of generic computer system validation (CSV) documents specifically tailored for Green Biotec software. Our experts are available to evaluate your overall risk, streamline validation efforts by prioritizing high-risk areas, and ensure compliance with regulatory guidelines and regulations. Partnering with Green Biotec enables you to efficiently and cost-effectively validate your computer systems, empowering your laboratory with robust validation solutions.
- Verification services
Green Biotec CrossLab Verification Services offers cost-effective verification for a variety of analytical instruments. Non-pharmaceutical analytical laboratories, including those in chemistry, energy, food, forensic, or environmental sectors, often operate under ISO 17025 guidelines or similar quality accreditations. Our verification process includes factory-recommended testing for LC, GC, GC/MS, and UV-VIS spectroscopy systems, providing documented evidence of optimal instrument performance. Additionally, metrology-based testing ensures the accuracy and verification of critical instrument functions.
- Green Biotec Cross Lab partner ACE
CrossLab Partner ACE is a cutting-edge compliance solution tailored for self-maintainers seeking to conduct compliance tasks internally while upholding superior levels of data integrity and traceability compliance compared to conventional paper, Excel, or PDF-based protocols. Self-maintainers undergo training and licensing to utilize Green Biotec’s automated compliance engine (ACE) software.
Partner ACE facilitates compliance standardization and simplifies compliance procedures throughout your organization. This licensed self-delivery compliance tool is specifically crafted for authorized self-maintainers and third parties operating in FDA-regulated laboratories. With patented, validated, and fully automated functionality, ACE compliance software instills confidence in the quality and reliability of your outcomes.
