5 Must-Haves for Electronic Batch Records in Pharma Manufacturing

Workflow optimization is a strategy for increasing manufacturing performance and efficiency. It enables your whole organization and teams to move, think, and complete tasks more quickly. It also reduces costs, errors, and time spent completing tasks.

What Pharma Companies Should Look For in an EBR Solution

A digital manufacturing solution needs to effectively optimize your manufacturing processes and production staff. For example, EBRs:

• Automatically track and store production data electronically in a central location.
• Collect relevant data right on the production line to improve quality and efficiency metrics.
• Connect SOPs, training, specifications, change control, etc. in real time from a central interface.
• Are 21 CFR Part 11 compliant with full data integrity measures and electronic signatures.

Integrating critical enterprise software fosters more effective cross-functional collaboration and increases efficiency when moving between systems. Common system integrations include enterprise resource planning (ERP), laboratory information management systems (LIMS), manufacturing execution systems (MES), and quality management systems (QMS). Many pharma manufacturers use this capability to connect their ERP with their EBRs. This way they can automatically launch a batch record directly from log materials consumed during production or a work order, then seamlessly update inventory after production is complete.

What Pharma Companies Should Look For in an EBR Solution

Your digital manufacturing solution needs to enable seamless, real-time connections between enterprise systems, data sources, processes, and people. Your solution should:

• Connect, monitor, and control your complex manufacturing systems and data flows.
• Share data with other functional areas in real time.
• Provide real-time visibility across all business units.

Having complete, up-to-date data gives you real-time insight across the pharmaceutical supply chain, so you can glean meaningful business intelligence and make better decisions.

What Pharma Companies Should Look For in an EBR Solution

It's important to have a digital manufacturing solution that can gather and proactively track production data and deploy advanced analytics functionality, enabling you to easily solve manufacturing inefficiencies. Your solution should:

• Capture and share structured and unstructured data across departments and systems.
• Ensure data is accurate and complete to provide insights needed to optimize operations.
• Eliminate data integrity issues before they impact the production life cycle.

You can accelerate batch review and release time by establishing cross-functional unity. For example, when manufacturing and quality can collaborate in real time throughout the production phases, pharma companies reduce errors, deviations, and redundant review cycles. In-process batch reviews are valuable for monitoring a variety of processes such as the condition of raw materials, status of equipment maintenance, mitigation of discrepancies, etc. before the batch is complete.

What Pharma Companies Should Look For in an EBR Solution

An effective digital manufacturing solution automates review, release, and tracking processes to ensure right-first-time lots. Your solution should:

• Be agile and able to immediately adapt to changes in manufacturing approaches, batch sizes, regulations, and trends.
• Minimize production inefficiencies.
• Reduce lead times.