5. Ensure that all staff members are comfortable interacting with inspectors. When the inspectors wish to discuss with staff members not on the support team, you will want them to feel at ease. By following the principles above, you can proceed with the knowledge and confidence that you need only present, and sometimes explain, what you have done. There is nothing to defend in the quality or integrity of your work. We know that this approach is successful, as Altasciences has consistently met inspection requirements for data integrity, reconstructability, SOP, and protocol compliance. “We know the inspectors have the same goals we do – to ensure that our study results are unquestionably reliable, with the safety of our participants, the welfare of our animals, and the rigor of our protocols and SOPs at the forefront of each activity, every day. Our teams make sure that we are always operating within that framework” says David Grégoire, Vice President, Compliance and Regulatory Affairs.