In today’s highly regulated pharmaceutical industry, maintaining ALCOA+ compliance is not just a best practice—it’s a requirement. ALCOA+ principles emphasize data integrity, ensuring that all data is attributable, legible, contemporaneous, original, accurate, and accompanied by supporting evidence. Achieving this level of compliance can be challenging, especially when relying on manual processes. This is where BMR software in drug manufacturing becomes essential, automating record-keeping and helping manufacturers meet ALCOA+ standards effectively.
Key Ways BMR Software Supports ALCOA+ Compliance
Accurate and Attributable Data Collection
BMR software ensures that every action in the manufacturing process is accurately logged and attributable to a specific user. With electronic signatures and real-time data capture, you can track who performed each task and when, reducing the risk of human error and non-compliance.
Contemporaneous Data Logging
Manual batch records can suffer from delays in data entry, but BMR software logs data as the process unfolds. This contemporaneous recording ensures that all entries are time-stamped and match the actual production sequence, meeting ALCOA+ expectations.
Original and Unaltered Data
Electronic Batch Manufacturing Records (eBMR) safeguard the integrity of data by capturing original values directly from integrated equipment and systems. The software prevents unauthorized alterations, ensuring the data remains unaltered and traceable
Enhanced Accuracy with Automated Workflows
Automation reduces the chance of errors, ensuring that calculations, measurements, and critical process parameters are accurately recorded. BMR software validates data entries against pre-set specifications, flagging any deviations that may compromise ALCOA+ compliance.
Without robust BMR software, maintaining ALCOA+ compliance becomes a labor-intensive process fraught with risks. Paper-based or manual batch record systems often fall short in delivering the accuracy, traceability, and real-time visibility required to meet these stringent regulatory standards. Automated BMR systems not only streamline operations but also ensure that every step in the manufacturing process adheres to ALCOA+ principles, safeguarding both product quality and compliance.
Take the Next Step with BMR Software
If your drug manufacturing process is struggling to meet ALCOA+ compliance, it’s time to upgrade to an automated BMR solution. BMR software in drug manufacturing ensures that data integrity, traceability, and accuracy are maintained throughout the production lifecycle. Don’t wait until an audit reveals gaps in your compliance—invest in BMR software now to stay ahead of regulatory demands and maintain the highest quality standards in your manufacturing process.