Electronic batch recording software

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

Pharmaceutical industry is passing through the major transition phase of automation. Stringent regulatory guidelines, globalization, cut-throat competition and changing supply chain structure have made this industry bound to redesign its working pattern and bring automation majorly. Electronic batch recording software playing an important role in this area. Traditional hybrid or paper based system is full