Solutions for complying with regulatory requirements in the pharmaceutical industry

Additional important operations that must be successfully implemented in the pharmaceutical industry include the integration of regulatory requirements (such as GAMP) and the management, monitoring and documentation of the entire application lifecycle management 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. An additional task is to successfully comply with the requirements of GAMP – which covers aspects such as computerised system validation (CSV) – in 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) application lifecycle management 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 benefit from our numerous years of industry experience and our expertise. We have already helped well-known SMEs in the pharmaceutical industry by successfully 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 references.

Having a customer relationship management (CRM) system that works well and is easy to use is therefore essential for the successful documentation and management of client relationships. This means that a modern CRM system is an important cornerstone. It facilitates advanced relationship 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 customer relationship management systems often fail to meet all of the desired requirements. Consequently, it is not possible to guarantee optimum service quality 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 means that carrying out the modernisation and optimisation work becomes a matter of urgency.

adesso advises you about the processes that need to be created and also assists you with the implementation and adaptation of your processes. We offer you our services as a proficient partner. We have a wealth of experience at our fingertips, which includes work with sector-specific solutions and projects relating to customer relationship management, marketing, customer service and e-commerce – both on the OTC and the Rx markets. We also have close partnerships with the market leaders in these areas (such as Microsoft and SAP), who offer both cloud and on-premises solutions. We would be glad to speak to you in person and provide you with detailed references.

At the same time, there is a focus on agile approaches to projects (Scrum) and on cloud computing operating scenarios, which are becoming increasingly important for system validation within the CSV (computerised system validation) 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 systems that operate in the cloud. Validation consulting for issues associated with computerised system validation (CSV) must therefore address all of these aspects.

Lawmakers are constantly specifying new requirements, which means that the pharmaceutical industry is always facing the challenge of satisfying regulations that relate to a constant flow of new issues. Furthermore, due to the ever-shrinking timeframes within which the solutions must (or should) be completed, the use of agile approaches to project management becomes necessary. Operating regulated solutions within cloud systems that are all over the world is also a challenging task.

adesso provides you with a comprehensive validation consultancy service for issues relating to computerised system validation (CSV). This service combines our indispensable regulatory knowledge and experience with agile (Scrum) and V-model approaches, IT development experience and a wide range of operating scenarios (cloud). In this way, we are able 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 references 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, application lifecycle management (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 taking into account 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 very 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 contract, such as a contract that is based on time and materials, a fixed price contract or performance-related remuneration.

You can benefit from our expertise and our numerous years of industry experience, which has included working with well-known SMEs. We would be glad to speak to you in person and provide you with detailed references.