Quality Management Systems «Gap Assessment» and Remediation

Category: Quality Assurance Consulting
The CEO of a San Francisco Bay area, clinical-stage biotech company asked Cilatus to provide strategic and operational Quality Assurance Leadership to ensure that their Quality Management System (QMS) was fit for purpose for the clinical-stage to which the company’s lead asset had progressed to. An initial «Gap Assessment» and diagnostic of existing QMS elements and processes was completed within weeks and then Cilatus developed a remediation/improvement plan to bring the client’s QMS to the desired, clinical phase appropriate state. Based on discussions with the client’s CEO and leadership team, it was decided that a Cilatus Senior QA Consultant should act as the Interim Head of Quality for the client. This enabled Cilatus to effectively integrate QA leadership, provide a fresh QA mindset, and sustain controlled QA processes to all key QMS areas: supplier qualification program, auditing of supply chain sites, and implementation of new and improved SOPs. At the same time, Cilatus provided operational QA oversight and QA input to the Client’s technical and clinical development effort. On behalf of the client, Cilatus reinforced the new Quality mindset by immediately investigating and resolving potential quality issues while ensuring continued clinical supply to ongoing clinical trials.