Say good bye to your old way of creating, keeping and reviewing batch records and embrace Process XE- electronic batch recording software (EBR)
According to the cGMP (Good Manufacturing Practice) Pharmaceutical manufacturers must properly maintain proper documentation and records. Proper documentation help to understand the whole manufacturing processes or functions of the past. Regulatory inspectors spend their maximum time in examining the company’s various documents and records. Effective documentation is a reflection of quality assurance system.
Pharmaceutical manufacturers are still using manual or hybrid system which consumes great amount of time, effort, and space to manage.
Further added risk of human errors, overlooked requirements, and forgotten processes. Due to this raw material and finished products need to wait for long till this manual paper based processes to be completed which result less inventory turns and blocked working capital. All of this adds up to higher costs and lost profits.
Pharmaceutical companies are now a days are encouraging automation of business processes to fight with the above mentioned obstacles.
Process XE- electronic batch recording (EBR) software is a web based solution which automate the process of preparing, releasing and controlling various pharmaceutical manufacturing documents (PMD) and master production control records (MPCR) and batch production control records (BPCR) are two most important of them. The purpose of preparing MPCR is to bring uniformity from batch-to batch which includes name of the product, name and codes of API, batch formula, batch or code no., identification of equipment, line and location used, start and finishing date with processing and packaging.
BPCR is exactly the replica of MPCR carries actual information about the manufacturing of each batch like material usage, dispensing activities, component weights , product output quantities, lot details, manufacturing nonconformance’s, and quality sampling and test results all add to this batch history. In simple words perfect solution to manage complete document life cycle, automated workflows, audit trials, electronic signatures, approvals, versioning, and archiving.
Process XE-electronic batch recording(EBR) software automate the execution and review of batch records, bring significant compliance and cost saving benefits to any manufacturer in cGMP-regulated industries. Capabilities include:
- Step control with step-based work instructions
- Qualification checks on all equipment and materials used
- Automated calculations
- Electronic signatures
- Forced authentication
- Forced sequencing
- Compliance flags indicating non-conforming data values
- Audit trails with operator identification and date/time stamp
- Trending reports and batch certificates
- Export data to external systems such as MES and ERP