How can heavily regulated pharmaceutical and biotechnology manufacturers keep up with changes? By being flexible and paperless. Yet that’s not as easy as it may sound. Finding the appropriate manufacturing execution systems (MES) is a foundation for success.
This eBook outlines why being flexible and paperless are now imperative. It goes on to point out the challenges of doing either of those. It explains MES, and why it’s crucial in supporting pharmaceutical companies’ journey to being flexible and paperless. Finally, it points to some specific advanced capabilities that this industry requires from MES for success today and in the future.
Please enjoy the summary* below. For the full research, please visit our sponsor Siemens (registration required).
For related research, read our insight to find out if the next steps of IT/OT convergence are at hand, hear how life sciences manufacturers can accelerate their innovation in this recorded webinar, and read our eBook to find out what manufacturers need in MES to be competitive today and in the future.
Table of Contents
- A Changing Life Sciences World
- Extreme Pressure on Production Operation
- The Flexibility Imperative
- Flexibility Challenges
- The Paperless Imperative
- Graphic: Paperless Benefits and Capabilities
- Challenges of Going Paperless
- MES or Manufacturing Operations Software
- MES Definition and Role
- How MES Addresses Flexibility Challenges
- How MES Enables Paperless
- Advanced MES Capabilities
- A Healthy BioPharma Future
The Need to be Flexible and Paperless
MES to Meet Pressures and Imperatives
All companies in the pharmaceutical industry are under pressure for time, quality, compliance, and innovation. These pressures create imperatives to be both paperless and flexible to protect profitability. The stresses and imperatives apply to small-molecule pharmaceuticals, active ingredients (API), contract drug manufacturers (CDMOs), large-molecule biotechnology, and gene and cell therapy makers.
Fortunately, a manufacturing execution system (MES) proven in these pharmaceutical segments can support many aspects of these imperatives. By choosing MES wisely, such a system can support success now and into the future.
Extreme Pressure on Production Operations
Pressures Mount
The pharmaceutical industry was once high-margin and relatively safe and consistent. However, more competition and new situations mean challenges from many angles. Four pressures are at the forefront: time, quality, compliance, and innovation.
Time
Time pressure is a multifaceted pressure—Time-to-market for new or smaller population therapies and time-to-deliver existing products to customers and patients who need them.
Quality
Patient safety and efficacy depend on end-to-end quality. This is not new, but the number of sites and companies involved often is.
Compliance
Regulators expect more from pharmaceutical manufacturers every year. Now, these expectations include digital approaches to speed the process and minimize chances for error.
Innovation
To succeed, companies are building a broad portfolio of products for multiple markets with specific regulations and needs. The innovation is often in related therapeutic areas to build strength in revenues and reputation.
Beyond Tradeoffs
Companies must seek no longer only tradeoffs between time, quality, compliance, and innovation. Pharmaceutical companies that pursue becoming flexible and paperless are on a path to enable all four simultaneously.
“We have a program for digital transformation in manufacturing particularly, also in Quality and other areas. The key is implementation of eBR.”
Nina Mikadze, Digital Transformation Leader, PHARMA INDUSTRY
How MES Addresses Flexibility Challenges
MES with eBR Design
eBR design capabilities can ensure any need is pre-designed for operations. Having designs that support a variety of possibilities means that the MES workflow can handle a higher mix rapidly and confidently. This up-front, behind-the-scenes work streamlines activities for those in production. People can handle the increased mix of flexible manufacturing much more confidently and with higher assurance.
Multi-product Design Space
Regulators want more therapies to reach patients who need them, so they have created guidelines for validated processes to handle more than a single process or product in a process design space. Using MES, companies can seamlessly leverage the specs and recipes or bills of process for a wide variety of products. This risk-based approach and the new CSA guidance will help ensure that validated processes can be flexible.
Auto-Document
MES automatically documents everything that occurs. It can also error-proof processes for each specific product. So, no matter how many products are in play in a given shift, MES can ensure they are processed correctly and document the details of each unit’s processing, including CFR21 Part 11 compliant e-signatures.
Assurance
In pharma, implementing MES is a matter of setting it up for every product. This means pivoting to process correctly, document thoroughly, and ensure quality. As a result, you can be assured that human error is minimized. This also makes the process easy to audit. With MES, all this happens during the process; after-the-fact assurance efforts vanish. Accurate data is a given with MES.
A Healthy BioPharma Future
A Healthy BioPharma FutureImperatives to Change
Pharmaceutical companies of every stripe urgently need to modernize and move to paperless, flexible operations. Time, quality, compliance, and innovation pressures apply to pharmaceutical, biotech, cell and gene therapy, API, and other suppliers to the industry. Those who don’t yet have a commercial, modern MES to address them are likely to suffer in the face of competition that does.
Key Take-Aways
- In today’s world, all eight aspects of industrial competitiveness matter:7 agile, innovative, resilient, engaging, responsive, insightful, sustainable, and improving.
- MES is a foundation for flexible and paperless operations and quality.
Recommendations
- Ensure you get modern and pharma-experienced MES to provide eBR and beyond.
- Evaluate your business strategy and match your focus for production software to meet both short-term and long-term needs for flexibility.
- Educate everyone on the value of paper-free documentation and provide training and systems that make it natural.
- Ensure the MES has advanced capabilities and works with newer technologies that can deliver value. According to Deloitte research, most pharma companies have used the cloud, wearables, and AR/VR already.8
- Make the move to MES positive for the workers using it – by selecting the right software, educating them up front, and setting it up to support and empower them.
- Set a strategy to digitalize your company and ecosystem and keep at it.
*This summary is an abbreviated version of the research and does not contain the full content. For the full research, please visit our sponsor Siemens (registration required).
If you have difficulty obtaining a copy of the report, please contact us.