Deloitte’s survey reveals that 77% of biopharma leaders view digital innovation as a key competitive differentiator. However, despite the clear benefits, transitioning to digital processes in the pharmaceutical industry isn’t a straightforward task.

Adopting Gartner’s Designed Simplicity approach with Mareana’s Connect™ CMC solution simplifies the process and overcomes obstacles effectively.

Digital Deployment Challenges in Pharma Manufacturing

Here are some of the key challenges your organization might face when deploying pharma digital solutions:

    1. Integration Complexities

      Digital transformation in pharma manufacturing entails integrating various technologies to ensure seamless interaction and optimized factory operations. Nearly 85% of pharma executives cite the integration of new digital tools with legacy systems as a major challenge.

    2. Building Trust

      According to the International Journal of Innovative Science and Research Technology (IJISRT), trust is crucial for successful digitization, particularly in this highly regulated industry. Concerns about data security and privacy can lead to resistance against digital transformation, amplified by high-profile cybersecurity incidents such as data breaches and industrial espionage.

    3. Costs

      The same IJISRT research also identifies the high costs associated with digitization as a major hurdle. Costs include model development, system revalidation, and regulatory expenses, as highlighted in Digital Chemical Engineering.

    4. Workforce and Change Management

      Deloitte reports that 47% of biopharma leaders consider securing the right talent a critical issue for digital innovation. Implementing new technologies and processes also necessitates effective change management strategies to ensure smooth transitions.

    5. Ensuring Regulatory Compliance

      Research from IJISRT highlights that regulatory concerns are the most significant barrier to pharmaceutical digitization, focusing on data availability, security, and quality. Ensuring digital tools and processes meet necessary validation, reporting, and data traceability standards is crucial to avoid severe penalties and reputational damage.

      For small pharma manufacturing companies, these hurdles are particularly daunting due to limited resources and expertise.

Removing Complexities with Designed Simplicity

Gartner’s Designed Simplicity provides a strategic framework to address digital transformation challenges in pharma by enhancing productivity through streamlined processes focused on user experience.

Effectively implementing this approach involves:

  • Defining focus areas and setting clear priorities: Find the right balance between narrow cost reduction and broad initiatives.
  • Identifying and delivering multi-value plays: Invest in initiatives that achieve multiple objectives to maximize resource utilization and impact.

So, where should you begin, and what focus area(s) should you prioritize to deliver multi-value effectively?

Starting with CMC: A Practical Approach

Chemistry, Manufacturing, and Controls (CMC) processes are at the heart of ensuring that pharmaceutical products meet regulatory requirements and quality standards. Focusing on CMC for digital transformation is strategic for several reasons:

Central to Product Quality and Compliance

Digitizing CMC processes enhances precision, reduces errors and non-compliance risks, maintains product integrity throughout its lifecycle, and builds trust.

Efficiency and Cost Reduction

Digitization of paper batch records in CMC streamlines operations, reduces costs, improves yield, enables faster batch release, and accelerates time to market, giving companies a competitive edge.

Enhanced Data Traceability

Implementing digital solutions for pharma and life science CMC processes allows for real-time visibility and improved traceability and accountability, crucial for regulatory compliance and quality control. Advanced analytics can also uncover insights to refine and enhance production processes further.

Mareana’s Connect™ CMC: The Simple Solution

Mareana’s Connect™ CMC embodies the Designed Simplicity principle, delivering superior digital CMC process optimization. The platform is specifically designed to tackle the complex challenges of digital deployment in the pharmaceutical industry, ensuring a seamless transition from traditional methods to more efficient digital processes.

Painless Integration

Connect™ CMC serves as the perfect entry point for digitalizing your pharma manufacturing processes by focusing on automating data extraction from paper batch records. This targeted approach tackles one of the most significant integration challenges in digital transformation—merging new digital tools with existing systems.

Enhanced Data Contextualization

Transitioning from paper-based processes to digital systems can be daunting due to the sheer volume of data that needs to be managed. Connect™ CMC automates data extraction from paper batch records and contextualizes this data into actionable insights. This reduces the time and effort required to make sense of complex datasets, enabling your team to focus on decision-making rather than data entry.

Streamlined Governance and Compliance

Ensuring that digital processes comply with industry regulations is a significant concern. Connect™ CMC addresses this with full audit logs and data traceability, which are critical for meeting CFR Part 11 compliance requirements. Additionally, the platform is built in accordance with global pharmaceutical standards, including FDA and EMA guidelines, and is fully validated and GMP compliant. This reduces the risk of non-compliance and helps maintain the integrity of your data throughout the product lifecycle.

User-Friendly Interface

A key aspect of reducing the pain of digital transformation is ensuring that the tools are intuitive and easy to use. Connect™ CMC is designed with user experience in mind, offering an interface that simplifies complex tasks and reduces the learning curve for your team. This minimizes resistance to change and helps your workforce quickly adapt to new workflows.

By addressing these deployment challenges head-on, Mareana’s Connect™ CMC not only simplifies the digital transformation process but also ensures that your transition to new methods is as smooth and pain-free as possible.

Transform with Ease Using Connect™ CMC

Starting with focused areas like CMC and adopting solutions like Mareana’s Connect™ CMC enable your company to overcome the complexities of digital transformation more effectively and achieve your strategic goals. This practical approach aligns with Gartner’s Designed Simplicity, ensuring a higher probability of success and turning digital deployment challenges into digital deployment realities.

Experience how Mareana CMC™ can streamline your digital transformation and boost operational excellence—request a demo today!