As a respected leader in regulatory compliant in vitro testing services and method validation, IIVS has the experience to help laboratories design and implement quality management systems. These systems should adhere to established quality standards, while also accommodating unique workflows of laboratories.
IIVS offers customized consulting services in establishing procedures for adherence to quality standards such as Good Laboratory Practices (GLPs), Good In Vitro Method Practices (GIVIMP), Data Integrity, Good Cell Culture Practices (GCCP), and the use of computerized systems and software. Our focus is to address the unique challenges posed by the application of these standards to in vitro work. Contact us to discuss how these programs can benefit your organization.
We began using Amanda Ulrey from IIVS as a consultant in 2017 when the 3M Strategic Toxicology Laboratory was implementing a quality system to allow us to perform GLP compliant in vitro studies. Over the years, she has provided general GLP guidance, SOP reviews and also a facility audit to help us fully implement our quality system. Her support was critical for us to successfully implement our quality system and she is a rare GLP QA expert that also has specific experience with in vitro studies, the exact type of support that we needed. I highly recommend Amanda and her excellent GLP consulting services, she has helped us immensely.
IIVS has developed an audit based program to assist laboratories of all sizes and levels of experience in implementing the GIVIMP guidance. Participation in the program demonstrates adherence to essential quality standards and builds confidence not only in the method, but also in the laboratories performing the testing. Each facility can set the scope of their certification, from one specific process or method to the operation of the entire laboratory. Self-selection of the scope of the program remove barriers that often prevent smaller and less experienced laboratories from implementing quality standards and participating in certification programs. Importantly, the certification program is not pass/fail but rather an iterative improvement process. Our quality professionals will provide an assessment of your current state of adherence to the principles in a a gap analysis document along with suggested prioritization of activities for further quality improvements. The facility can determine if they would like to meet the core competencies and become GIVIMP Verified or if they would like to continue making additional improvements and be GIVIMP Certified. Two key strengths of the program are the flexibility of the structure for each facility and the prioritized way further quality improvements are recommended.
The IIVS certification program harmonizes the interpretation of the GIVIMP guidance across laboratories, provides practical advice on implementation, resulting in improvement in the reproducibility of in vitro work.
If you have questions or would like to join our GIVIMP certification program, please contact IIVS.