Successful digital transformation of upscaling processes in the chemical and GxP-relevant pharmaceutical environment.
Introduction
The pharmaceutical industry, like hardly in other sector, is under constant pressure to produce efficiently, safely, and in compliance, while rapidly implementing innovations. Customer requirements change quickly and must be met with high quality standards. Flexibility is particularly important in upscaling, the crucial step between laboratory and large-scale production. This is where new approaches are scaled, processes optimized, and production protocols continually adapted. It is precisely in this dynamic environment that the importance of digital solutions becomes clear – solutions that do not slow things down but rather enable agile development. A prime example of successful digitalization is a pharmaceutical client who has, during the upscaling phase, been dynamically generating and implementing the required documentation for regulated and GxP-relevant processes over the past four years using the MES system anicomply.
From Paper to Digital – The Initial Situation
The initial situation was typical: like many departments in the pharmaceutical industry, the upscaling department initially worked with paper-based protocols. Creating, adjusting, and storing the so-called batch records was time-consuming, error-prone, and significantly slowed down agile processes. It quickly became clear that an MES (Manufacturing Execution System) was urgently needed to overcome the disadvantages of paper documentation. However, finding the right solution proved more difficult than expected:
- The common MES products were too rigid and not designed for the continuous changes in upscaling.
- Process changes would regularly require significant effort with digital documentation, involving external service providers and system revalidations.
- This would result in lost time and additional costs—exactly what an agile upscaling department aims to avoid.
Modern Processes Need Flexible Systems
What challenges do standard solutions often face? In upscaling, many new formulations, process variants, and methods are developed—and discarded—in a short period of time. This calls for digital solutions that can keep pace with this speed. Conventional MES systems are often designed to map processes that have already been established, rather than being able to adjust them flexibly and quickly.
The advantages of paper-based documentation—such as the ability to write and adapt protocols yourself—should be retained and enhanced through better accessibility of digital protocols. Technical experts, in particular, must be able to independently create new protocols and document processes. Good digitization can set standards especially in this area.
anicomply: The Solution for Agile Production
What was needed was a system that combines the advantages of paper (freedom, flexibility, independence of the experts) with the advantages of digital solutions (efficiency, traceability, compliance). The answer: anicomply—a software specifically designed to support agile work digitally, especially in upscaling.
Digital Protocol Creation Without Programming Skills
With anicomply, experts can independently create, edit, and deploy digital protocols, without requiring additional IT resources. This empowers them to quickly modify, combine, or discard formulations and process steps as needed. The days when every adjustment to the MES required expensive external developers and complex revalidations are over.
Validated GxP Operation With Maximum Flexibility
The implementation of anicomply in a validated GxP environment enables significant synergies to be generated. Regulated processes that must meet the highest standards of traceability and data integrity can now be documented digitally in a flexible, audit-proof, and validated manner. The solution is designed so that protocol changes can be validated with streamlined processes and minimal effort—an enormous advantage in the day-to-day operations of agile upscaling departments.
Intuitive Operation – By Experts, For Experts
Finalized protocols are made available in the MES system with a simple click, approved, and immediately accessible on the shop floor. Production personnel can execute them in compliance with GMP-standards using a tablet, computer, or even a smartphone, and record each step directly in the system. The intuitive user interface of anicomply ensures a smooth onboarding experience, eliminating the need for extensive training.
Success Story: Four Years with anicomply
For four years, anicomply has supported the upscaling department on its path toward digitalization. The software is continuously evolving—with a strong focus on the specific challenges and needs of its users. The result: a digital documentation platform that accelerates production processes.
- Experts can independently create protocols and generate GMP-compliant variants without needing IT specialists or developers.
- Production staff benefit from clear workflows and the ability to document directly and compliantly.
- Management gains visibility into processes and can perform targeted evaluations.
- The company saves time and costs while increasing process reliability.
Customer Experiences: Voices from the Field
What do users say? A few selected comments from the department show how anicomply shapes their daily work:
“Thank you for your commitment. Thank you for the productive collaboration—especially during challenging times. I always enjoyed working with you to make things happen.”
“… in our daily work, we’ve valued [anicomply] for more than four years—now validated—and therefore also suitable for our ‘regulated’ approaches going forward.”
“I’m aware that there are now many discussions around ‘paper on glass’ or ‘electronic batch records.’ Depending on the requirements, there are good commercial solutions out there. But for ‘flexible, organic production’ and similarly complex work environments (with a large number of individual instructions that need to be flexibly combined), [anicomply] is an excellent solution!”
Conclusion: Digitalization That Enables Processes—Not Blocks Them
In a world where processes and products must be adapted ever more rapidly, digitalization is key—but only if it supports, not hinders, the way experts work. The implementation of anicomply in the upscaling departments of our customers in the
chemical and pharmaceutical industries demonstrates how agile, GMP- and GxP-compliant production becomes possible—built on freedom, flexibility, and expertise.
anicomply is more than just a “paper on glass” system: it is the foundation for a production environment that continuously evolves—while always keeping people at its core.
For further information or a product demonstration please contact us.
