An EBR solution that is integrated with enterprise information systems improves compliance and streamlines the creation of batch record
The pharmaceutical and biotechnology industries have been bound by strict regulations for a long time. In fact, few other industries must contend with such high levels of control, transparency and traceability. In pharmaceutical manufacturing, these high levels of compliance and quality are necessary to sustain business and uphold patient safety and confidence.
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As part of those regulations, authorities require that records be kept of each batch of product that a company produces. The information held in batch records can be accessed during assessments and is used to confirm that the appropriate procedures are followed, material inventory is controlled, operators’ identities and training levels are verified, and the necessary quality checks are performed.
It is also used to assess the effectiveness of continuing product improvement strategies and initiatives. For many companies, capturing this information is a challenging and imperfect manual process. Manufacturers that have successfully deployed information technology to improve efficiency in other domains have traditionally found batch record reporting difficult to automate.
As the power of computing has grown, software has evolved, the cost of digital storage space has shrunk, and the ingenuity of people in connecting information systems and databases has improved. Modern electronic batch record solutions are coming to market that can integrate with other enterprise systems to enable much better control over the capture and analysis of batch data.
Dangers of Outdated Documentation Methods
Why do most pharmaceutical manufacturers still use manual, paper-based processes to create batch records? The most likely answer is the simplicity of the solution. It’s easy to walk around a manufacturing facility with a pen and paper. This doesn’t require a lot of expensive equipment or complicated IT initiatives. Operators simply read values from dials and meters on production equipment or dispensing lot labels and fill in the values on a printed form on a clipboard.