Digital excellence –
we are realizing tomorrow’s future today!

The global economy is currently undergoing a revolutionary phase of digitalization. Even the life science industry is confronted with the challenges of digital transformation. The key to long-term success and competitiveness for regulated companies lies in bridging the immense gap between strict regulatory requirements and the implementation of the latest technology, thereby enabling successful digitization. For every company it is crucial to analyze, evaluate, plan, and implement value creation in order to ensure the most optimal digitization solution for each requirement. This is where the specialists at Pharmatronic come into play and employ their expertise to develop innovative solutions and build the bridge between technology and compliance for their customers.

Content

The Bridge between Technology and Compliance
Digitalization & CSV Framework
The Key to validated Computer Systems for Digital Excellence
Debut for the PAG Process of the CSV for AI to Agile Project Method in a regulated Environment
The Specialists for Digitization and Computer System Validation

The Bridge between Technology and Compliance

In the age of digitalization, the progressive development of the economy is accelerating the increasing dynamism of the life science industry. There is a significant pressure to integrate real-world data[1] and to utilize AI-based analytics particularly in the everyday operations of companies.

Courage, trust, and expertise to employ the latest and sometimes untested technologies within a regulated environment are required to remain competitive in this fast paced and agile world. These technologies must also, of course, provide demonstrable assurance of the safety and efficacy of drugs, ensure patient protection, and meet the increasingly complex requirements regarding data integrity and security.

To invest the immense effort only to appear „modern“ and be labeled as „progressive“?
No! There is, of course, much more to it:

The adoption of these technologies promises substantial efficiency enhancements in digitized areas, revolutionary process optimizations for the entire organization, and the opening of entirely new perspectives for the management to make quality and performance-enhancing measures decisions through previously unknown insights and KPIs – at all times, transparently and agilely. Moreover, such technologies enable the discovery of untapped potentials and the identification of pathways to create new and profitable business areas.

[1] Real-world data is data that originates from the real world and has not been generated synthetically or artificially. It is often unstructured and can come from various sources, such as sensors, observations, surveys or transactions. It serves as the basis for statistical analyses, machine learning, predictive models and decision-making.

Image: The competitiveness of companies requires digital transformation

Various industries, such as automotive , financial services, information technology, and retail / e-commerce, have been benefiting extensively and without limitations from the rich advantages generated by the use of these technologies for several years, driving the developments of the technologies and global economic progress at a rapid pace. However, what hinders the life science industry from harnessing the countless benefits with its technological know-how and strong resources? What prevents the life science industry from benefiting from or even leading these intense developments?

This deficit can be attributed to the high and stringent regulatory requirements for the use of such technologies in regulated environments. The introduction and use of new and untested computer-based technologies, particularly in conjunction with data processing on cloud platforms or the use of artificial intelligence (AI) and machine learning (ML), pose significant risks for regulated companies concerning the demonstrated assurance of product quality, patient safety, and data integrity.

THE SOLUTION – the long-awaited solution is an adequately validated systems throughout their entire life cycle. Without the key of „Computer System Validation“ (CSV), it is not possible to develop or implement modern technologies that provenly meet the high regulatory requirements and ensure that the systems continuously deliver accurate and traceable results that are always documented in a GxP-compliant manner. With the key of CSV and under the increasing pressure of economic efficiency, the life science industry is now ready for the unstoppable revolutionary digitization with a focus on digital excellence.

Image: CSV – the key to digital transformation of regulated companies

Digitalization & CSV Framework

The experienced management in regulated companies are increasingly plagued by a multitude of difficult questions without clear answers. „Can we even control these unknown technologies (autonomously)?“ „Where should digitalization start and end for us?“ „Which of these countless technologies is a good fit for us?“ „What will a digital transformation cost, and what long-term costs and resources do we need to calculate?“ „What risks are we actually taking, and to what extent would we truly benefit?“

As an independent and future-oriented service provider, Pharmatronic focuses on transparently resolving these questions for their customers. At the beginning of 2023, we expanded our expert team in the „Digitalization & CSV“ department in order to develop individually tailored solutions for all our customers.

The result is a modular Digitalization & CSV Framework of PAG, which is designed as an integrated approach to allow a solid digital transformation. This framework has been developed from four components that can be individually combined.

Image: Integrative & modular approach with configurable components

With the «Process Excellence» component, we analyze the current processes, along with the existing risks, and provide comprehensive advice on achievable options for new designs and optimizations. We employ a structured and goal-oriented approach to reorganize processes and operations before, during and after the transformation to ensure a smooth and efficient transformation to the new structure.

The «Technology Management» component thoroughly addresses the analysis, consultation, and integration of suitable technologies in specific areas of the companies. This includes the intensive analysis of operational requirements in order to provide adequate advice on offers and solution variants. We use our expertise to develop an efficient method for integrating the selected technology into ongoing operations in compliance with regulatory requirements.

Through the «Computer System Validation» component, we analyze the compliance and status of computerized systems and ascertain a GxP-compliant integration, employing the appropriate validation method following the GAMP5 2nd Edition. We determine the necessary resource requirements for satisfactory cyber security.

To complete the all-inclusive package, the «Management Consulting» component offers, among other things, a comprehensive and transparent analysis of investment and project costs, investment comparisons, and forecasts, along with a life cycle budget for implementing the desired digitalization and relevant alternatives. In addition to the technical challenges, we always focus on helping people to find their emotional and professional transition in their new and digital environment during and after the transformation.

Image: Technology Management – Security for human, data and technology

The Key to validated Computer Systems for Digital Excellence

The appropriate technology has been selected for regulated operation! Or should it even be developed in-house? The IT department is ready to program, install, configure… but wait! Companies are already being slowed down by additional challenges. A jungle of requirements in the GxP area must be known and adhered to: EU GMP Guideline, Annex 11, CFR21 Part 11, GAMP5 2nd Edition, and countless other regulations, rules, restrictions, and provisions. Plans, analyses, categorizations, supplier evaluations, reports, evidence, inspections, and results are demanded. The systems aren’t even in operation yet, and the first critical auditors are announcing themselves. But what exactly is expected for each system? What deliverables are needed? Which CSV methods are accepted by the authorities? Which documents need to be maintained throughout the life cycle and which need to be archived? What do I need to consider if the systems are cloud-based? How do you validate a GxP compliant AI or ML system? And when is an agile project method GxP compliant and more efficient than the traditional and established methods?

The specialists of the Pharmatronic team Digitalization & CSV also offer confident support here. Equipped with the new, innovative, and modular PAG process for CSV in a GxP regulated environment, while adhering to the GAMP52^nd Edition, we navigate projects in an experienced and structured manner towards their goal. For absolute comfort service, the PAG process is accompanied by a customizable assistant: an extensive repertoire of documentation templates for the entire life cycle of development, validation, and implementation of a computerized system within a GxP environment according to the GAMP5 2nd Edition. This arrangement of a comprehensive CSV all-in-one solution with integrated intelligent functions agilely interacts with our customers‘ complex projects and supports the project team with automated conclusions combined with sound expertise. This allows for an individual computer system validation at the highest level for all regulated computer systems, categories, and every level of complexity. Not only following the established V-model, but also following the latest project methods of the GAMP5 «Agile“ and „Iterative“, which enable the development and validation of AI systems in a GxP-regulated environment. To guarantee international service, the arrangement is available in German and English for our customers.

Image: Pharmatronic focuses on the solution for digitization issues

This complete package as the key to validated computer systems for the digital excellence of the experts Digitalization & CSV is a representative milestone of Pharmatronic AG to enthusing our customers with a professional, transparent and recognized approach while also exploring new market opportunities as a leading specialist in Digital Excellence within the regulated environment through innovative strategies.

Debut for the PAG Process of the CSV for AI to Agile Project Method in a regulated Environment

The innovative PAG process of CSV (Computerized System Validation) has already achieved initial successes despite its recent creation!

Among them, an international customer from the pharmaceutical industry has used the expertise of the PAG specialists in Digitalization & CSV, along with their PAG process of CSV using the „Agile / Iterative for AI Systems“ development and validation method, to develop another performance-enhancing technology. This technology is set to establish a new standard in the GxP-regulated market for process development and quality control for the near future.

In this particular project, the project team developed a measuring device that is able to automatically analyze, evaluate, and document the produced items during ongoing production processes using its adaptive software in a GxP-compliant manner. Current controls of this nature are done laboriously and through time-consuming manual efforts by employees. They capture images of the microscopically small measurement objects in the production line and manually count the identifiable items in the images, which they later measure, evaluate, and assess in terms of size and granularity. Meanwhile, the already completed product must be stored and controlled in an expensive interim storage until it is released by the QC (Quality Control) department. Under unfavorable circumstances, production facility may have to be paused until the batch has been released. The risk of undiscovered quality defects and errors in quality control, due to human errors, could be drastically reduced at this point.

By utilizing the newly developed technology, this quality control process of the produced items can be automated and documented significantly faster and more efficiently, without costly interruptions to production processes caused by time-consuming manual quality control analyses. The reduction in error risks, achieved through the consistent high reliability and more precise accuracy of computerized technology compared to human performance, is just one of the many optimizations that the use of this digital technology brings along. The produced items can be released at the end of the batch without long waiting times for the next process. The production facility can be released significantly earlier for the production start of the next batch, thereby drastically reducing costly downtimes and efficiently optimizing the entire process chain, ultimately leading to a significant increase in performance.

Bild: Digital Transformation improves sales increase, quality, performance and efficiency

The product quality is monitored more quickly and efficiently, ensuring patient safety in accordance with all international requirements. Simultaneously, it allows for increased production volume with reduced quality control costs, thus enhancing the revenues of PAG’s customer.

The Specialists for Digitization and Computer System Validation

Comprehensive understanding of various technologies and the ability to customize them to meet the specific needs of our customers distinguishes us as professional partners for regulated companies seeking to optimize their processes and increase efficiency. We possess expertise in validating complex computer systems and meeting associated regulatory requirements.

However, our expertise extends beyond purely technical aspects. We recognize the importance of taking a holistic approach to consider all involved stakeholders and processes. With our interdisciplinary approach, we create effective solutions that not only meet the demands of technological innovation but also prioritize people.

Our commitment to staying up to date with the latest technology and continuously evolving enables us to address the challenges posed by the dynamic and agile transformation of the life science industry with high professionalism. Digital transformation is a complex process, but with subject matter experts like us, it becomes a rewarding investment for companies in the life science industry. We are motivated to develop opportunities for change and set new standards for excellence and innovation. Our progress speaks for itself, and we look forward to achieving further successes in the future with and for our customers by building the bridge between technology and compliance.

„With each challenge, we grow; with each solution, our customers experience a moment of triumph.“

Image: Our specialists and point of contact for „Digitalization & CSV“ are Nicole Schnetzer (Process Consultant) and Andy Tran (Head of Digitalization & CSV)

Digital excellence –
we are realizing tomorrow’s future today!

Content

The Bridge between Technology and Compliance

Digitalization & CSV Framework

The Key to validated Computer Systems for Digital Excellence

Debut for the PAG Process of the CSV for AI to Agile Project Method in a regulated Environment

The Specialists for Digitization and Computer System Validation

Nicht nur Projekte … auch Verleih

Kontakt

Kontakt

Pharmatronic

Digital excellence – we are realizing tomorrow’s future today!

Content

The Bridge between Technology and Compliance

Digitalization & CSV Framework

The Key to validated Computer Systems for Digital Excellence

Debut for the PAG Process of the CSV for AI to Agile Project Method in a regulated Environment

The Specialists for Digitization and Computer System Validation

Nicht nur Projekte … auch Verleih

Kontakt

Kontakt

Pharmatronic

Digital excellence –
we are realizing tomorrow’s future today!