Automated Operating Procedures (AOPs) run routine regulatory and quality work the same way every time. Your RA and QA experts build them without code, and they follow the process your team already uses.
Each AOP applies your own reference materials and positions at every step, rather than a generic template.
AOPs follow the SOPs, templates and review criteria your team already works to.
Institutional knowledgeChain literature search, screening, extraction, drafting and translation into one procedure.
Unified platformBuild and revise AOPs without engineering support. RA and QA experts write the procedure, and Arca runs it the same way every time.
Self-serveArca reasons through each step, so a procedure can handle an unusual case and adjust when the evidence changes.
Agentic executionStart from Arca's library of pre-built procedures for common regulatory and quality work. Adjust the parameters, add your reference materials and publish to your team.
List the repetitive tasks that take your team's time, such as literature updates, answers to agency questions, change assessments and CAPA summaries.
Compose steps from Arca's tool library and your own SOPs, templates and prior submissions.
Run the AOP on real cases, review the output, and revise the steps until the result matches what your reviewers expect.
