Additional important operations that must be implemented in the pharmaceutical industry include the integration of regulatory requirements such as GAMP, and the management, monitoring and documentation of the entire ALM process.

The sector must grapple with agile development models, such as Scrum, which pose a particular challenge. The traceability of the whole process must also be guaranteed – from the requirements list right through to the finished application. In addition, companies must also comply with the requirements of GAMP – which covers aspects such as computerised system validation (CSV) – with respect to normative and regulatory documentation.

We advise you on the build process and on the further development and optimisation of a comprehensive (and, if sensible and desired, agile) ALM solution that is in line with GAMP. We can also provide support in the form of CodeBeamer, a suitable partner solution from Intland Software, and we can provide you with ready-made templates for GAMP. This approach facilitates comprehensive compliance with the latest requirements.

You can from our many years of industry experience and our expertise. We have helped well-known companies in the pharmaceutical industry by building agile solutions and by integrating appropriate tools, for example. We would be glad to speak to you in person and provide you with detailed testimonials.

Having a customer relationship management (CRM) system that works well and is easy to use is therefore essential for successfully charting how to document and manage client relationships. This means that a modern CRM system and a professional e-commerce platform form key building blocks for business success. They facilitate advanced marketing and the long-term maintenance of customer relationships – whether by using social media, social engagement marketing or customer portals. This makes an important contribution to the success of the company.

Existing CRM systems often fail to meet all of the desired requirements. Consequently, it is not possible to guarantee top-quality customer support for certain services and products for clinics, doctors, pharmacies and end customers. Furthermore, it is not possible to embed the technical specifics of the pharmaceutical industry into existing CRM solutions, which creates a need for modernisation and optimisation.

Together with you we analyze the current CRM solutions and design and implement adaptations to future-proof your business processes. We are an expert partner who stands by your side with a wide range of experience in industry-specific solutions and projects as well as in topics related to customer relationship management, marketing, service and e-commerce in the OTC and Rx market. You also benefit from our close partnerships with market leaders such as Microsoft and SAP, who offer both cloud and on-premise solutions. We would be glad to speak to you in person and provide you with detailed testimonials.

At the same time, there is a focus on agile approaches to projects (Scrum, SAFe) and on cloud computing operating scenarios, which are becoming increasingly important for system validation within the CSV framework.

In addition to the well-known V-model, there are new approaches to projects that make it possible to use agile models such as Scrum and, in the area of validated solutions, GAMP 5. Alongside these, the FDA and the EU define certain issues – such as 21 CFR Part 11, GxP and regarding systems that operate in the cloud. Validation consulting for issues associated with CSV must therefore address all of these aspects.

Legislation constantly sets out new requirements and thus constantly challenges the pharmaceutical industry to overcome new regulatory hurdles. Furthermore, due to the ever-shrinking timeframes within which the solutions must be completed, the use of agile approaches to project management becomes necessary. Operating regulated solutions in cloud systems around the globe is another pressing challenge.

adesso provides you with a comprehensive validation consultancy service for issues concerning CSV. This service combines our indispensable regulatory knowledge and experience with agile approaches, V-model procedures, IT development experience and a wide range of operating scenarios (on-premise, cloud). This makes it possible for us to model a process that strikes the perfect balance of necessity and pragmatism.

In addition to this, our longstanding project-based experience allows us to offer you the option (if desired) of gradually integrating agile approaches into ongoing projects for which you are currently using a V-model – while maintaining compliance and efficiency.

You can benefit from our industry-specific expertise and our project experience, which has included developing validated processes and solutions in this market segment. You can also reap the benefits of our experience with adesso’s New School of IT (NSoIT), which centres around modern, innovative approaches and solutions. We would be glad to provide you with detailed project testimonials on request.

In this industry, ensuring that the various design, development and operating processes are integrated with the regulatory requirements (such as those of GAMP) is just as important as the construction, management, monitoring and documentation of an application lifecycle management (ALM) process.

• Standards and procedures: GAMP 5, CSV (computerised system validation), IEC 82304
• Technologies: Web, web apps, apps, iOS, Android, HTML 5, Java, Microsoft, AngularJS
• Methods: IREB, ISTQB, Scrum, Kanban, agility, ALM

The pharmaceutical industry needs to make use of new development models (such as Scrum) in order to ensure that the design and development of IT solutions is efficient in terms of development time, cost and quality, while also considering all of the regulatory requirements. Design and development tasks still have to be outsourced due to strained resources or lack of available capacity, skills and expertise.

Within the regulated environment of the pharmaceutical industry, we offer a wide range of technologies and provide you with a variety of ways to approach your projects, for example using the V-model or an agile/Scrum approach. Furthermore, you can choose from various types of contracts, such as a contract that is based on time and materials, a fixed price contract or performance-related remuneration.

You can benefit from our many years of industry experience and our expertise with renown clients. We would be glad to speak to you in person and provide you with detailed testimonials.