Seeing the bigger picture: maximising DMS/ECM project success
It isn’t always easy to step back and take the broad perspective when a new document or content management system requirement is bearing down. But, until life sciences companies start taking an end-to-end view and appreciating the wider impact on people and processes, they risk compromising a successful delivery for the business, says Karsten Krüger of MAIN5 Management Consulting.
Pharmaceutical organisations do a great many things very well, but it can be easy to underestimate the demands and efforts of new information system projects – incurring a risk that these initiatives will fail.
Whether the motivation for a project is a company merger or acquisition, a harmonisation/rationalisation drive, a system refresh, or a specific new regulatory requirement such as IDMP or GDPR, life sciences companies still too often approach document or content management system (DMS/ECM) projects as targeted activities to achieve a specific single goal.
On top of this, they may set their parameters too narrowly in terms of the people they involve, the timeframes they allow, and the scoping of user requirements. This can lead to costly project overruns, poor user buy-in and – at some point down the line – disappointing results and even project failure. And the financial implications can run into hundreds of thousands (if not millions) of euros.
So it is surprising that the vast majority of pharma organisations continue to plan and deliver DMS/ECM projects in the same sub-optimal way, time after time.
Standing on the shoulders of others
It’s a subject we’ll explore in one of two sessions we’re running at AMPLEXOR’s Be the Expert meeting in June. Based on numerous electronic document/content management projects that we’ve helped clients plan, manage and deploy, we’ll be drawing together some of the major lessons companies are learning about successful delivery.
Some of it is about appreciating the need to include department heads and user representatives from across R&D – stakeholders from Regulatory Affairs, Clinical and Pharmacovigilance teams, as well as IT. This is critical to ensure that new systems serve the fullest purpose, work for everyone, and will have maximum application – as user requirements evolve and grow.
Whether companies bring in external help or not, the responsibility for delivering results cannot be passed off to a third party. Without internal ownership, and sufficient thought about how processes need to work, and the impact on individual roles, the best plans can go awry. A common mistake we see is project responsibilities being added to the workloads of already busy people who lack the capacity to expand the vision and review broader processes.
Another is to confine project parameters to a single use case in a single department. Not only does this limit the potential benefits; it also increases the likelihood of other, future projects in other parts of the business replicating much of the same groundwork – ad infinitum.
Planning for the unknown
In one of our two speaker sessions, we’ll be exploring what’s involved in taking a more holistic approach to content management. Not just inter-departmentally, reducing duplication and improving people’s line of sight across products and processes. But also in helping companies develop a more flexible foundation for absorbing and responding to future regulatory and user-driven information requirements that are not yet known. Although this approach to planning is currently the exception rather than the norm, it can pay dividends – allowing companies to adapt more swiftly and painlessly each time new requirements emerge.
Ultimately, this is about agility. There will always be ‘projects’: as one ends, another appears on the horizon – so that planning for each as a distinct entity no longer makes sense; not if the pharma business is to meet its long-term strategic and operational goals.
From engaging and increasing the awareness of business sponsors in the IT initiatives they have prompted, to building multi-disciplinary teams that can help influence the right kind of change, we’ll be providing practical advice on the most effective and efficient approaches to end-to-end DMS/ECM delivery, based on the real and recent experiences of a cross-section of our clients. We hope to stimulate a decent debate!
* Karsten Krüger and Gero Neidlinger are managing partner at MAIN5 GmbH & Co. KGaA in Germany. The company advises on and helps pharmaceutical firms to deliver organisational change, processes and systems in a successful way.
MAIN5 at the DIA Europe 2018 in Basel
The management consulting company MAIN5 with its exclusive focus on strategy, process and system consulting in the regulated value-added areas of the pharmaceutical industry will be exhibiting for the first time at DIA Europe 2018 in Basel from April 17 to 19, 2018 with booth number 3.
"During the three days at the DIA we will give an extensive insight into our methods and projects of the past months." comments Gero Neidlinger, Managing Partner at MAIN5 " Simply looking at past projects with selected case studies we have prepared ourselves for an active dialogue with interested specialists. We are ready to discuss our concepts for the analysis, selection and introduction of innovative business solutions and solutions from the areas of global labeling document management, training concepts for global quality processes, validation, introduction of international patient support programs, GDPR in life science and business process management in pharmaceutical R&D."
For MAIN5, the DIA exhibition is a great stage for the presentation of its holistic solution and project approaches specialized in the life sciences industry. Based on clearly formulated goals that support a project in the corporate context, MAIN5 focuses on the analysis and development of effective processes, as well as the introduction of suitable solutions. MAIN5´s uniqueness is clearly the exclusive orientation of its method- and expert-centered consulting approaches to the requirements of the pharmaceutical industry. In connection with its young business academy, the MAIN5 Institute, MAIN5 always moves at the pulse of time, - develops and imparts modern and practical methodology and leadership competence.
"Our corporate development in recent years clearly shows that hardly any other industry recognizes so much need for consulting and catching up as the pharmaceutical industry. Particularly with regard to process management and digitization, there are still considerable treasures buried that will provide the industry with further innovations and efficiency advantages in the coming years“, says Tore Bergsteiner, Managing Partner at MAIN5, "Our consultants and teams continue to educate themselves and gain valuable impulses from adjacent industries. In order to maintain and expand existing competitive advantages in an international comparison, we have already successfully distinguished ourselves in a large number of sensitive projects".
Armin Neises is taking over as head of the MAIN5 Institute
MAIN5 has recruited Armin Neises for the expansion of the MAIN5 Institute! With its ambitious business academy, the pharma management consulting company trains line managers and senior managers on how they can safely navigate their teams and initiatives in a competitive and rapidly changing environment. At the same time, the MAIN5 experts for organisational change in life science companies also envision their young institute as a think tank. The academy offers participants an inspiring space for exploring relevant topics outside of the everyday pressure and routine, to meet in an informal setting and to share experiences.
‘The current social and intercultural changes have also shaken up the pharmaceutical industry’, commented Tore Bergsteiner, Managing Partner at MAIN5. ‘The unprecedented insights that patients have in the information age, the disappearing clear structures in a network society and the noticeable progress of new digital players require an urgent review of and adjustments to management methods and strategies for success. We are all the more pleased to entrust the experienced and dedicated leader Armin Neises with the development of our institute.’
Neises is a certified General Manager and has already set up and run successful business academies. He has many years of experience in management consultancy and training. To date, he has trained or consulted more than 2,000 line managers and senior managers from several reputable industrial companies. As Director of MAIN5 Institute, he plans to expand the industry-specific curriculum in such a way that traditional, innovation-based companies in the pharmaceutical and medical devices industries will also be able to cope with internal and external challenges in the future. To start with, there will be a seminar program that focuses on areas such as the complexity in the pharmaceutical business and BPM as a management tool in pharma R&D. The goal is to bolster the business skills of scientists and doctors working within the context of the pharmaceutical industry.
One special aspect of MAIN5 Institute is that the method-oriented and value-driven curriculum for its training courses is focused exclusively on the specific requirements of the pharmaceutical industry. Another special aspect is that the young business academy imparts a firm, modern and practical understanding of management and leadership: What intelligently steered organisational changes can introduce valuable organisational flexibility? How can prudent management thwart the efforts of people resisting reforms; how can it involve employees in the process; and how can prudent managers be empowered so they can act with confidence?
‘Life scientists, physicians and engineers who are highly qualified in their respective disciplines and are entrusted with managerial functions in the life science industry are approaching us today with very specific requirements and problems regarding management and leadership’, explains Armin Neises, Senior Director of MAIN5 Institute. ‘They need modern, more subtle and dynamic forms of leadership in order to meet their need for self-monitoring and participation. Our trainers are extremely well-acquainted with this environment and they possess extensive experience working in the industry and up-to-date management know-how. They can also offer a change in perspective that points the way forward for management.’
22nd GQMA (German Quality Management Association e.V.) International Meeting, Maritim Hotel Würzburg
The German Quality Management Association e.V. (GQMA) is the largest expert association for quality management in the chemical and pharmaceutical industry in Germany and the second largest in Europe. Every year in the fall, the association holds its annual international meeting, which is attended by several hundred experts from industrial companies, contract research organizations, hospitals and public authorities. The wide array of topics discussed at the conference enables experts to be kept up-to-date with the latest developments, to take home important suggestions that can be incorporated in their daily work routine, and to make valuable contacts with representatives from other related industries.
Ms Verena Jachmann from Fresenius-Kabi in Oberursel and Ms Sabine Schmidt from MAIN5 in Frankfurt am Main will be giving presentations on the topic of "Roll out and implementation of a globally harmonized eQMS” during the Risk Management Session at the 22nd GQMA International Meeting (Friday, September 22, 2017 morning session).
Registration / Information:
Online registration is available through the event agency CSM:
Event organizer: GQMA, German Quality Management Association e.V.
After its Rebranding, MAIN5 Remains on Course for Growth
FRANKFURT AM MAIN, SCHAAFHEIM, GERMANY, July 25, 2017: After a highly successful four-year start-up phase, the management consulting firm MAIN5, which focuses exclusively on strategy and implementation solutions for the regulated added value sectors in the pharmaceutical industry, remains on course for continued growth. Last year, the firm was again able to increase its sales and earnings.
The consultancy firm made up of more than 20 consultants has built a solid customer base comprised of renowned TOP 50 global players and selective regional medium-sized companies, and today it is presenting itself more confident and optimistic than ever. The firm, which was founded in 2013, is currently making targeted investments in the advancement and expansion of its excellent network of consultants, the maintenance and development of its customer relations over the long-term, and in the development of a strong MAIN5 core brand.
New business relationships are increasingly being established on the basis of recommendations made by existing customers or as a direct result of the seminars run by the MAIN5 Institute. Tore Bergsteiner, one of the Managing Partners at MAIN5, explains, “The key decisive factor for companies in the pharmaceutical industry is being successful in their multifaceted endeavors. The trust we have received and the values our firm lives by are now incorporated in our brand identity and serve as an additional valuable impetus for our firm’s development.”
Some of the more obvious aspects that characterize the complexity of MAIN5’s activities include the increasing regulatory requirements that are associated with highly dynamic changes; the increasing pressure from the competition and the accelerating pace of innovation by international comparison; the growing pressure to curb costs by national healthcare systems; the unconstrained market consolidation taking place; and the ongoing digitalization of all business processes and interfaces. Alexander Tryba, another Managing Partner at MAIN5, sums up the firm’s position in the market in a nutshell: “There are many consultancy firms working in this field, but at the end of the day, having insider knowledge accounts for the subtle difference between top-notch experts and mediocre consultants.”
After its rebranding at the beginning of 2016, the young firm has put itself in an even stronger position. Its new brand identity and its disciplined process management enable MAIN5 to release new energies and to be focused on realizing further growth.