BatchRecordIt

BatchRecordIt is a web-based application designed to streamline the process of creating and managing batch records in pharmaceutical, biotechnology, and other regulated industries. Batch records are essential documents that detail the procedures and specifications for manufacturing a batch of a product, ensuring compliance with regulatory standards such as those set by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The software automates and organizes these records, reducing manual errors and improving efficiency.

Developed with compliance in mind, BatchRecordIt integrates with existing enterprise systems like Electronic Batch Records (EBR) and Electronic Data Capture (EDC) platforms. It supports standardized templates and workflows, allowing users to customize forms and approval processes to fit specific operational needs. The platform also includes features for version control, audit trails, and real-time collaboration, which are critical for maintaining regulatory integrity.

Key features of BatchRecordIt include automated data validation, role-based access control, and integration with Laboratory Information Management Systems (LIMS) and Manufacturing Execution Systems (MES). The software is particularly useful for companies transitioning from paper-based or legacy systems to fully electronic batch recording. Its cloud-based architecture ensures accessibility from multiple locations, facilitating remote work and global collaboration.

BatchRecordIt is designed for industries where regulatory compliance is non-negotiable, such as pharmaceutical manufacturing, vaccine production, and medical device development. By reducing administrative burdens and minimizing human error, the platform helps organizations focus on quality and innovation while adhering to strict industry standards. The software is regularly updated to incorporate new regulatory requirements and technological advancements.