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5 Must-Haves for Electronic Batch Records in Pharma Manufacturing

By now you've realized that pharmaceutical companies do themselves a disservice by using paper-based manufacturing processes. It's time for the pharma industry to take the next step toward more practical, efficient, and cost-effective operations.

1: Manufacturing EBR Workflow Optimization

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.

Benefits of Digital Connectivity

[MasterControl EBR] shortened the time I need to do batch book reviews, because they're just there and I can do them at any time of the day. I don't need to gather all the paperwork together and look through it all. I can have 10 tabs open at once and it's way easier.

- Laura Glenn, production supervisor at Almac Sciences

2: Connected Manufacturing Systems

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.

3: Complete and Usable EBR Data

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.
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of pharmaceutical manufacturing professionals report that missing/unusable production data is their biggest pain point.

- MasterControl Executive Report: "Digital Maturity in Pharmaceutical Quality and Manufacturing

4: Timely Product Reviews and Releases

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.

MasterControl's review-by-exception functionality makes sure we never release a batch that has an out-of-spec in-process parameter.

- Bruce Johnson, VP Immunotherapy Mfg. West Coast, Dendreon
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Using EBRs, a cellular therapeutics developer reduced batch management, review, and closure time by 50%.

5: In-Depth Manufacturing Traceability

Effective traceability means having complete visibility from raw materials through production to the finished product and beyond. For example, a traceable bill of materials (BOM) makes it easy to identify suppliers and the lot number of raw materials. This time-saving capability eliminates the need to implement supplier modifications or other changes to designs after manufacturing has begun.

What Pharma Companies Should Look For in an EBR Solution

Your digital manufacturing solution needs to provide real-time, searchable information pertaining to the manufacturing phases of each product line. Your solution should be able to trace:

  • Suppliers.
  • All manufacturing changes as they occur.
  • Defects, deviations, and nonconformances.
  • Identified or potential risks.
  • Data and the data's history, such as to verify that processes are performed according to SOPs.

Through MasterControl, after a few months of data in the system, I can forecast more precisely when certain kinds of devices will be ready to be shipped. This will allow sales to give customers more accurate timelines for shipping and delivery.

- Imran Hussein, manufacturing engineer at Northeast Scientific
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