Batch Records

Electronic batch manufacturing records (EBMRs) are digital versions of paper-based batch records used in the manufacturing industry. They serve as comprehensive documentation of the manufacturing process, capturing crucial information such as batch details, materials used, equipment specifications, manufacturing steps, quality control tests, and operator activities. EBMRs are stored electronically within software solutions, enabling easy access, […]

Electronic Batch Records (EBRs) and Electronic Batch Manufacturing Records (EBMRs) have revolutionized the manufacturing industry by digitizing paper-based batch records. These electronic systems provide comprehensive repositories of information, ensuring product quality, consistency, and compliance with regulations. In this blog post, we will explore what EBRs are, their benefits, and the steps involved in getting started with […]

EBMR Software Electronic Batch Manufacturing Records – eBMR software is a critical tool for the pharmaceutical industry to ensure compliance, improve efficiency, and maintain product quality. It automates and streamlines the manufacturing process, replacing paper-based records with digital records. Read more about the need of electronic batch recording software to ensure compliance in Pharma and healthcare industry. […]

Paper batch records are replaced by an electronic batch recording software. The application provides a complete solution with electronic signatures and audit trails. The electronic batch recording software, includes text, graphics, data, audio, pictorial or other information represented in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system. The […]

Pharmaceutical companies are often on the cutting edge in terms of research, but when it comes to manufacturing they are, in many ways “tied up with paper”. Regulatory reporting burdens have transformed historically driven complex procedures and paperwork into electronic batch recording software in order to ensure compliance. A significant problem with historic paper-based systems […]

In a paper-based environment, creating and maintaining master batch records (MBRs) involves huge effort. During production, manual entry is subject to human error, information can be duplicated because of multiple systems, and it takes a lot of time to gather and input all relevant data. The review and reconciliation of this information is also time-consuming.Standardization […]

Every phase of research and development, manufacturing and quality control and product distribution must be thoroughly documented and reviewed at every phase. Maintenance of these records is vital to the day-to-day operation of every pharmaceutical company manufacturing and marketing drugs and is necessary for establishing a detailed audit trial for every lot of product manufactured. […]

Pharmaceutical industry is one of the industry needs to comply with stringent regulatory and quality guidelines to reassure the superior quality of medicines they are delivering for the wellbeing of human health. Effective management of batch recording documents like Master Production Control Record (MPCR) and Batch Production Control Record (BPCR) is very important part of […]

As a Pharmaceutical company, your proof of success is found in the document records that you keep. Documentation is your proof that your product and services are produced in compliance with cGMP regulations and your company’s operating procedure and standards. That’s why it’s said that any Pharmaceutical organization is producing two things drugs and paper. […]

This transition journey of Pharmaceutical industry towards electronic processes like- electronic batch recording software (EBR), supply chain management software, quality management software, distribution software and many more, would be incomplete without first mentioning the International Conference on Harmonization (ICH). ICH was formed in 1989 to bring uniformity and standardization in the formats called Common Technical […]