INTRODUCTION CELL MANUFACTURING, QC, CLINICAL TRIALS CASE STUDY METHOD Gradalis is a biotechnology company focused on the development and commerciali- zation of novel personalized therapeutics to treat cancer. Vigil® utilizes the patient’s own cancer cells to create a fully personalized cancer immunotherapy with the goal to activate the patient’s own T-cells against their cancer cells. Vigil® requires an autologous manufacturing process. Prior to implementing L7|ESP, Gradalis issued paper-based batch records that were completed by hand-writing in observations, data, and signatures. All calculations were manually performed and written to complete the process step, and allow for subsequent QA review. Additionally, Gradalis’ records were siloed based on function, with evidence of completion

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