Controlling and documenting quality processes is essential. Processes that are not consistent, repeatable, and documented can increase compliance risk, negatively impact the company's brand, and limit the team's ability to react to quality issues before they reach patients. SOP management and maintenance is foundational to a sponsor’s quality management program.
In addition, documentation that supports compliant manufacturing and controls is imperative for a successful quality program. The complex document life cycle of CMC (Chemistry, Manufacturing, and Control) documents can pose a challenge. Optimized document review and finalization processes are essential to maintain compliance and audit readiness.