Pharmaceutical Manufacturing Industry Reference Architecture
Business capability maps, value streams, and strategy maps for the Pharmaceutical Industry.
The pharmaceutical manufacturing industry is experiencing a transformative phase, shaped by technological advancements, regulatory changes, and global market pressures. You are constantly challenged by:
- A lack of clarity while capturing the right information, engaging the right people, or linking with the needs of the business and aligning with operational technology (OT).
- A lack of business and IT-aligned view of mission, strategy, goals, objectives, processes, projects, and measures of success.
- Presence of OT and IT silos that miss the big picture and don’t understand the need for a synergistic approach for successful outcomes.
Our Advice
Critical Insight
Using an industry-specific reference architecture is critical to understanding, modeling, and communicating the operating environment and the direction of the organization. This will enable measurable, top-line organizational outcomes and the unlocking of direct value.
Impact and Result
Info-Tech recognizes the value in business-IT synergy. Info-Tech will:
- Demonstrate the value of IT’s role in supporting your Pharmaceutical manufacturing business capabilities while highlighting the importance of proper alignment between organizational and IT strategies.
- Apply Level-2 business reference architecture techniques such as strategy maps, value streams, and capability maps to design usable and accurate blueprints of your Pharmaceutical manufacturing operations.
- Assess your initiatives and priorities to determine if you are investing in the right capabilities. Conduct capability assessments to identify opportunities and to prioritize projects.
Pharmaceutical Manufacturing Industry Reference Architecture
Business capability maps, value streams, and strategy maps for the pharmaceutical industry.
Analyst Perspective
Tackle disruption, end misalignment, and enable IT-led value realization.
The pharmaceutical manufacturing industry is experiencing a transformative phase, shaped by technological advancements, regulatory changes, and global market pressures. Pharmaceutical manufacturing is seeing increased adoption of advanced technologies such as artificial intelligence and machine learning. These technologies are revolutionizing the way drugs are discovered, developed, and manufactured. Additionally, the use of big data analytics is enabling manufacturers to make more informed decisions, enhancing efficiency and productivity. The integration of these technologies is speeding up the drug development process and helping to reduce costs and errors, leading to higher quality products.
Global regulations are evolving, becoming more harmonized globally, facilitating international collaboration and distribution, but also demanding higher compliance standards from manufacturers. Pharmaceutical companies are investing more in compliance management systems and are more frequently undergoing audits and inspections to ensure adherence to good manufacturing practices (GMP) and other regulatory requirements. Sustainability is also becoming a key focus, with companies increasingly adopting greener manufacturing practices and reducing their environmental footprint.
The industry is moving toward a future that promises more efficient, safe, and tailored pharmaceutical production, albeit with the need for the industry to adapt to emerging challenges and technological advancements.
Shreyas Shukla
Principal Research Director, Manufacturing Industry
Info-Tech Research Group
Executive Summary
| Your Challenge | Common Obstacles | Info-Tech's Approach |
| You are a CIO or head of IT who wants to:
Improve your organization's understanding of business capabilities. Communicate how IT can support the creation of new products. Sharpen IT's alignment and focus on organizational outcomes and value by using technologies that produce the most reliable and high-quality outcomes. Before executing any strategic initiatives, use this blueprint to understand how the organization creates value. |
You are constantly challenged by:
A lack of business and IT-aligned view of mission, strategy, goals, objectives, processes, projects, and measures of success. Presence of OT and IT silos that miss the big picture and don't understand the need for a synergistic approach for successful outcomes. |
Info-Tech recognizes the value in business-IT synergy. Info-Tech will provide:
A means to build your organization's capability map by defining its value stream. The ability to define your strategic focus by understanding the organization's key capabilities. A means to assess these key capabilities, processes, and applicable technology support. A way to adopt capability-based strategy planning by identifying and mitigating capability gaps. |
Info-Tech Insight
Using an industry-specific reference architecture is critical to understanding, modeling, and communicating the operating environment and the direction of the organization. This will enable measurable, top-line organizational outcomes and the unlocking of direct value.
Industry Overview:
Pharmaceutical Manufacturing
Pharmaceutical manufacturing is highly regulated and complex and begins with discovery and development. This stage is where scientists conduct extensive research to discover new drugs and develop the active pharmaceutical ingredient (API). It involves target identification, synthesis, and preclinical testing, including both in vitro and animal studies. Researchers focus on understanding the drug's interactions with the body and the body's effect on the drug.
Following discovery, the process moves to scale-up and pilot. This phase is critical for transitioning from laboratory-scale to commercial-scale production and involves optimizing the synthesis process for larger batches and conducting pilot batch production to simulate actual manufacturing conditions.
Clinical trials are an essential component in pharmaceutical manufacturing used to test the drug's safety and efficacy in humans. The successful completion of clinical trials is crucial for the drug to proceed to the next stage. Trials are followed by regulatory review and approval, which involve submitting data from trials to regulatory bodies for a thorough evaluation of the manufacturing process, controls, and compliance with regulatory requirements. Once approved, the drug can be manufactured and sold.
Commercial scale manufacturing includes the actual production of the drug, quality control and assurance, packaging, labeling, and distribution. This stage requires adherence to strict manufacturing standards and regulatory guidelines. Post-marketing surveillance is also a crucial part of this phase, where the drug's performance, safety, and effectiveness are continuously monitored in the general population. The goal of this final step is to ensure that safe, effective, and high-quality medication is consistently produced and made available to patients in need.
Figure above: Value Chain for the Pharmaceutical Manufacturing Industry
About Info-Tech
Info-Tech Research Group is the world’s fastest-growing information technology research and advisory company, proudly serving over 30,000 IT professionals.
We produce unbiased and highly relevant research to help CIOs and IT leaders make strategic, timely, and well-informed decisions. We partner closely with IT teams to provide everything they need, from actionable tools to analyst guidance, ensuring they deliver measurable results for their organizations.
What Is a Blueprint?
A blueprint is designed to be a roadmap, containing a methodology and the tools and templates you need to solve your IT problems.
Each blueprint can be accompanied by a Guided Implementation that provides you access to our world-class analysts to help you get through the project.
Need Extra Help?
Speak With An Analyst
Get the help you need in this 4-phase advisory process. You'll receive 9 touchpoints with our researchers, all included in your membership.
Guided Implementation 1: Adopt Capability-Based Strategy Planning
- Call 1: Introduce Info-Tech’s industry reference architecture methodology.
Guided Implementation 2: Use Business Capabilities to Define Strategic Focus
- Call 1: Define and create value streams.
- Call 2: Model Level 1 business capability maps.
- Call 3: Map value streams to business capabilities.
- Call 4: Model Level 2 business capability maps.
Guided Implementation 3: Assess Key Capabilities for Planning Priorities
- Call 1: Create a strategy map.
- Call 2: Introduce Info-Tech's capability assessment framework.
Guided Implementation 4: Adopt Capability-Based Strategy Planning
- Call 1: Review capability assessment map(s).
- Call 2: Discuss and review prioritization of key capability gaps and plan next steps.
Contributors
- Chris Goodhue, Managing Partner, Info-Tech
- Kevin Tucker, Principal Research Director, Info-Tech
- Dr. Nihar Kumthekar, Asst. Professor, Operations & Supply Chain, University of Southern Maine