Validation Services

SunBio IT strives daily to provide superior service and support in a consistent, cost-effective manner. If your research is being conducted under an approved IND or IDE, the underlying computer systems used to collect and analyze data must be validated to meet FDA requirements for electronic records and signatures. Whether you are purchasing all or part of a system from a vendor or using your own system linked to university resources, you are responsible for demonstrating that the system meets 21 CFR Part 11. To meet this compliance, SunBio IT can provide a variety of validation services, as follows:

  • 21 CFR Part 11 Compliance
  • Quality Assurance
  • Quality Control
  • Regulatory Affairs Support
  • Quality Compliance & Auditing
  • GMP Auditing
  • GLP services
  • GMP services
  • SOP services
  • GRP services

Pharma GMP Audit Software

In conjunction with select industry experts, SunBio also offers a wide range of pharmaceutical cGxP auditing services that conveniently facilitate cost-effective quality assurance management for outsourced global supply chains. SunBio is also in the process of designing web-based Audit Management Software solutions that can judiciously streamline internal and external audits for global manufacturers and ensure significantly better compliance with regulatory standards.

These tools are being designed by adopting best industry practices in such a way as to enable vastly improved audit scheduling , planning and trailing as well as flexible integration of recognized quality management systems – such as CAPA management or ‘Out-of-Specifications’ management criteria for raw materials testing – into a seamless and controlled workflow. Our versatile solutions are further designed for total compliance with 21 CFR Part 11, harmonization and accuracy in data capture, live tracking and traceability of ‘Out-of-Trend’ scenarios, generation of customizable real-time Metrics and Summary reports with graphical representation and so on, thus greatly optimizing the automation and tracking of entire audit cycles.

Correspondingly, our Technology Partners also offer considerable breadth of experience with respect to auditing the production of a broad variety of APIs and Finished Formulations in particular and in ensuring their total compliance with diverse global regulatory standards such as those mandated by US-FDA, UK-MHRA, TGA-Australia, AFSSAPS-France, etc.