Life sciences companies are facing a fast-changing environment of regulatory pressure and customer expectations for personalised treatment, compounded by demands from investors and shareholders. Ensuring competitiveness in this climate through reduction of potential deviations and investigations, and by decreasing time to market (achieved by optimising the pipeline from R&D to manufacture) will be critical for ongoing success and even survival.

Targeted treatment solutions are the next evolutionary step in pharmaceutical development, and these require the transformation of industrial processes. Within many life sciences organisations, the manufacturing function operates at a level well below its potential. Significant productivity and efficiency gains can be routinely delivered through intelligent utilisation of automation solutions to optimise processes and ensure quality, compliance and performance. The winners in tomorrow’s life sciences marketplace will be those who embrace and take advantage of the benefits of new manufacturing technologies and solutions, in order to gain competitive advantage.

PAPERLESS PRODUCTION IS POSSIBLE

One solution with the potential to revolutionise manufacturing flexibility, efficiency and productivity is electronic batch recording (EBR), which allows for review by exception with real-time batch release. All relevant process and product quality data are collected and analysed against specifications and then used to automate the batch release processes. EBR speeds up the production cycle and reduces inventory through faster batch release.

Batch reporting and management are critical processes within the production value chain that require both validation and efficiency. The legacy paper-based operating procedure, which is commonplace within many pharmaceutical manufacturing facilities, gets the job done, but the timing and impact on subsequent processes and production metrics are often overlooked. There is also the ongoing challenge of managing and archiving the large volume of critical paperwork generated by each batch production run. Furthermore, paper-based systems are error prone and the resulting process of resolving the issues delays batch releases even further.

With sophistication entering the automation, MES and IT infrastructure layers within life sciences industries, continuing to use such an archaic paper-based process is a significant limiting factor in reaching greater overall equipment efficiency (OEE) and productivity improvement. Ultimately, it becomes a hindrance to achieving operational excellence.