Our Services: End-to-End or Specific Needs
“Keeping you in Compliance” is our mission. At 11 Compliance Consulting, we assist clients with all stages of the electronic quality system. We can help with the end-to-end process from system selection to implementation to maintenance; or we can focus in on an individual system, process, or initiative. We are committed to finding the best solution for each client’s specific needs in the most efficient way possible.
We specialize in end-to-end compliance from selection to implementation to validation, maintenance and training to help you stay current with regulations. We are experts and well-versed in: 21 CFR Part 11, GAMP 5, 21 CFR Part 820, ISO 9001, ISO 13485, ISO:/IEC 27041 to name a few.
At system selection, you can count on us to help navigate options and select a vendor for a system including eQMS, eDMS, LMS or QMS. We have you covered, whether you are looking for a gap assessment to determine needs, are issuing an RFP, or want to tap into our years of experience with systems plus staying abreast of the latest regulatory changes. On, implementation, you can focus on your mission knowing the installation and deployment of your system and processes are in good hands by pairing our experts with yours: the perfect combination. We review your workflow and process in developing a plan for configuration as well as for validation where we take the least burdensome approach.
We stay with you after the implementation for training your team, including ‘train the trainer’, high-quality instructional material, and linkage to the LMS. Our managed services include maintenance and evaluation services to ensure smooth operations and help when you need it to quickly resolve issues and minimize downtime.
Learn more about each of our services and how we can help keep you in compliance.