The FDA, OSHA, DHHS all have requirements that firms must “establish and maintain” procedures for all safety and quality-related, GxP compliant processes. To do so, companies should define, document, and implement standard operating procedures (SOPs). This is the only way companies can ensure that their organization develops and manages operationally sound procedures that are compliant with the law. Many companies fail this first step of insuring regulatory compliance, either completely lacking in SOPs, not training their staff, or not keeping the SOPs current with the most up to date requirements.

Whether it’s a completely new set of SOPs, or a comprehensive assessment of your current SOPs against the latest regulations, recommended guidelines, and industry “best practices”, STI has the expertise to help you. STI doesn’t stop there, once the SOPs are in place, STI can create customized online training courses through STI-EMS to educate your staff to document training and comprehension, and keep you prepared for audits.