Top 5 Benefits of Digitizing your Manufacturing

Executive Summary

The adoption of Pharma 4.0 principles and acceleration of digitization across the pharma manufacturing industry offers many growth opportunities for the industry, delivering significant process advantages that eliminate siloed systems and long-standing manufacturing inefficiencies. Going digital allows companies to fully integrate their supply chains and improve operational processes, making them more adaptive and responsive. As a result, improvements across planning accuracy, manufacturing efficiency, productivity, and inventory monitoring can be realized.

More flexible manufacturing processes, paired with deeper insights that lead to faster decision making, means that critical therapeutics get delivered to patients faster. Taking a digital-first approach also helps brands align with customer requirements, leading to increased customer satisfaction and experience. 

On the regulatory front, digitalization introduces opportunities for real-time monitoring, data validation, and compliance automation, facilitating a more agile and responsive regulatory environment. This shift toward digitized regulatory processes has the potential to accelerate approvals and improve overall regulatory compliance. The FDA continues to push pharma organizations to modernize operations in order to foster innovation, increase quality, and improve supply dependability.

Read on to learn what’s driving this push toward digital maturity and the top five compelling reasons to consider making the move this year.

#1: Drastic Reduction in Processing Time

Streamline Your Workflow 

Organizations can expect to enhance efficiency, accuracy, and collaboration throughout the entire pharmaceutical manufacturing process as going digital replaces manual, paper-based documentation. Agile platforms such as Tempo, can cut process times by up to 50%, thanks to automated data entry and reporting. By eliminating manual logbooks and batch records, organizations can expect a faster turnaround that leads to immense time and cost savings.

Going digital not only reduces the risk of errors associated with manual data entry, but also streamlines the documentation process, making it more efficient and compliant with regulatory requirements. With digital platforms, real-time collaboration is also enabled across internal and external sites and teams, which accelerates strategic decision-making, speeds up problem solving, and reduces overall time to market.

#2: Minimized Error Rates Mean Maximized Savings

Cut Costs on Corrections

Data mishandling poses significant risks to the integrity, quality, and regulatory compliance of the manufacturing process. The average error rate for manual data entry can be as high as 1%. Inaccurate data can compromise product quality, lead to regulatory non-compliance, and potentially result in recalls or other regulatory actions. Limited visibility offered by paper hinders an organization’s ability to promptly identify and address deviations or issues, potentially leading to delays and quality issues.

By switching to digital, organizations can virtually eliminate these errors, potentially saving up to 0.5% of total revenues typically lost to data mishandling in pharma manufacturing. Digital platforms immediately enhance the reliability of manufacturing records lending itself for early error detection allowing for prompt corrective actions that minimize the risk of a quality issue.

#3: Avoid Compliance Pitfalls and Associated Fines

Stay Audit-Ready

Today’s digital platforms can help ensure that conditions are within specified parameters, allowing for immediate adjustments and interventions if deviations occur. This proactive approach minimizes the risk of quality issues and enhances overall process control. Digital systems can also automate compliance monitoring by tracking adherence to regulatory standards throughout the manufacturing process. This not only ensures compliance but also simplifies the preparation for regulatory audits and reporting.

Paper-based systems have a higher risk of non-compliance, which can result in fines amounting to 5% of annual revenues. In order to navigate the regulatory landscape more effectively, avoid compliance pitfalls, and reduce the risk of associated fines, organization should look to adopt robust, digital systems that are fully validated and built to enhance traceability. 

#4: Reduce Storage Costs and Optimize Space 

Shrink Storage and Management Expenses

Digital records can simplify batch tracking, reduce the risk of errors, and optimize data storage. By eliminating the reliance on paper, organizations can forgo unnecessary costs related to data entry, storage, retrieval, and lifecycle management.

The cost of storing paper documents can be as much as $0.25 per sheet when considering space, filing, and retrieval. With digital records, these costs are virtually eliminated, saving upwards of $20,000 per year for a mid-sized manufacturer.

It's important to note that transitioning from paper-based records to digital solutions can offer immense cost savings over the long term. Digital systems reduce physical storage requirements, enhance accessibility, and reduce errors, contributing to greater operational efficiency and lower ongoing expenses.

#5: Increase Operational Efficiency and Output

Boost Your Bottom Line

Digitalization transforms traditional operational models by introducing real-time data monitoring, automation, and enhanced connectivity. Digital MES solutions have been shown to improve overall manufacturing efficiency by at least 20%.

The real-time visibility across the entire pharmaceutical supply chain that digital solutions offer extends from raw material procurement to distribution. By optimizing production schedules and reducing downtime, organizations can greatly enhance overall supply chain efficiency.

Conclusion

Digitization holds immense transformative potential for research and development, manufacturing, supply chain management, regulatory compliance, and patient care. The path forward toward digital maturity has now become a critical component of pharma’s operational strategy and roadmap. Organizations that seize the initiative can give themselves a sustainable competitive advantage; operate with greater agility, cost-efficiency, and control; and ultimately provide better care for patients.

The switch from paper to digital is not just a step towards modernization—it's a strategic move that yields significant cost savings as well. The integration of digital-first technology throughout the pharmaceutical value chain contributes to a more agile response to dynamic industry demands.

With Apprentice's Tempo Manufacturing Cloud, the potential for reducing expenses and boosting efficiency is clearly defined in its offerings. Embrace the digital revolution and turn the page from paper-based losses to digital gains. Want to learn more? Schedule a demo of Tempo today.