jun. 26, 2024
By: Director of quality Assurance , Mehul Gandhi
As 20204 begins, Sofgen Pharmaceuticals is making significant strides in elevating its quality standards by embracing a transformative shift from a conventional paper-based quality system to a cutting-edge electronic QMS (eQMS), along with a focus on electronic batch records (EBRs). Recognizing the need for agility, accuracy, and compliance in the pharmaceutical industry, Sofgen has initiated a forward-looking strategy to enhance its quality management processes. This move is driven by a commitment to staying ahead of industry trends and ensuring the delivery of top-notch pharmaceutical products to our partners.
The groundwork has been laid and Sofgen is in-process of implementing the eQMS and EBRs in a phased approach with different modules expected to go live beginning second half of 2024.
The adoption of eQMS and EBRs is a pivotal step for Sofgen Pharmaceuticals in its pursuit of operational excellence. By digitizing and automating the batch record process, the company is not only reducing the risk of errors associated with manual data entry but also accelerating the entire quality control lifecycle. Real-time data access and analytics provided by the electronic system will empower Sofgen to proactively identify and address potential issues during manufacturing, ensuring product quality is maintained at the highest standard. This transition is not only a testament to Sofgen's commitment to quality but also positions the company for future advancements in pharmaceutical manufacturing, aligning with regulatory requirements and industry best practices.