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 The post The all about electronic batch recording software,MPCR and BPCR. appeared first on eBMR solution from Sarjen - Process XE.
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 The post Need of electronic batch recording software to ensure compliance in Pharma and healthcare industry. appeared first on eBMR solution from Sarjen - Process [...]
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 The post How does the Electronic Batch Recording Software improve Pharmaceutical manufacturing processes? appeared first on eBMR solution from Sarjen - Process XE.
Pharmaceutical, Life science and Health Care are few of the industries need to operate under continuous pressure to remain competitive while meeting the stringent regulatory manufacturing requirements. These manufacturing requirements include simple electronic record keeping to complex data assuring consistently the reliability of the manufacturing processes, equipment testing, peoples training, raw material quality, sampling plans, The post ROI factors for implementing Manufacturing Execution System (MES) in Pharma. appeared first on eBMR solution from Sarjen - Process XE.
Pharmaceutical and Life science are few of the early adopters of information technology for quality compliance, process optimization, reducing errors, involving the supply chain and increasing profit. According to a report published by Gartner in 2010, there is a huge need of integrated IT manufacturing technologies, supported by the fact that the increase in corporate The post Growing popularity of manufacturing execution system (MES) in Pharma appeared first on eBMR solution from Sarjen - Process XE.
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. The post How the Electronic Batch Recording Software benefit you? appeared first on eBMR solution from Sarjen - Process XE.
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 The post Electronic Batch Recording Software-Salient features appeared first on eBMR solution from Sarjen - Process XE.
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. The post How electronic batch recording software encounter the challenges of pharmaceutical industry? appeared first on eBMR solution from Sarjen - Process XE.
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 The post Transition of Pharmaceutical industry towards electronic processes appeared first on eBMR solution from Sarjen - Process XE.
According to good manufacturing practices (GMP) your each process should be documented properly to establish evidence that your process, operated within pre-established parameters to prove that the produced drug and dietary product meeting its pre-determined specifications and quality attributes. Before establishing the importance of creating and maintaining batch manufacturing records, let’s understand what batch manufacturing The post Why batch manufacturing records are so important according to GMP? appeared first on eBMR solution from Sarjen - Process XE.