We are specialised to make your processes efficient and achieving objectives for your projects.
Sanders & Associates‘ clients are either industry (mostly subject to regulations) or suppliers ensuring best support to their customers.
Sanders & Associates‘ engagements currently include the fields of Quality / Project / Program Management.
Our main service areas include Quality Management (e.g. computerized system validation and operations) and Project / Program Management. In addition, we provide Communication and Support Services, ensuring sustainability and effectiveness across the range of our services.
To achieve sustainable results, Sanders & Associates combine core expertise in Project Management and regulatory compliance/Quality Management with the required support functions. We work directly or remotely with our clients, driving projects or changes in most cases in an international environment. Through our extensive industry experience we are used to working with multiple stakeholders and people from different cultural backgrounds. Together with our hands-on approach, this enables us to facilitate improvements and change in our clients organization and project teams.
Due to our years of operational experience, we know how to operate, check, audit, improve and monitor Quality Management not only in the context of cGMPs (current Good Manufacturing Practices). With the knowledge of key success factors and pitfalls we achieve efficiency and compliance for your Project and programs. We gauge risks in order to establish and implement a robust validation strategy while aiming to create resilient systems for our clients.
Sanders & Associates has a deep understanding of regulations, the pitfalls arising from international environments, and the collaboration of multiple disciplines. We translate your project's needs into a strong plan. Efficient tracking and reporting with a solid communication concept will help you to do an informed judgement on your project status. Our years on the ground will help you to strike the balance between Quality, Budget and Timeline to achieve your particular objectives.
As certain communication and support activities make IT Project and Quality Management significantly more efficient, our service to clients always includes professional Communication and Support Services. This comprises professional Technical Writing of procedures and technical documentation (including GER/ENG translations), effective communication for project marketing and stakeholder onboarding/update, as well as Change Management for sustainable improvements in our client’s processes.
Professionals for sustainable improvements in your project and organization
Globally standardised methodology for development and operation of software solutions
At Bayer Technology Services GmbH, the Software Development& Support Community (SDS.Com) governs standards for development as well as operation of software solutions. The objective of the SDS.Com explains Dr. Thomas Birsztejn: „Key for our community is to continually safeguard the high quality standards for our software solutions. On top of that, by means of common working processes we target increasing efficiency of services along the entire life cycle of our solutions. By maintaining these high quality standards while enhancing efficiency we will retain our position as market leader.“
This in mind, the joint effort to review and standardize the internal working processes was initiated in May 2013 under leadership of Dr. Thomas Birsztejn.
Dr. Astrid Sanders describes the approach of this project: „ Our objective was – across all departmental boundaries – to define the standardized working processes jointly in a team with the future users. The targeted efficiency gains we wanted to realize by making pre-defined work packages available to the teams. This way we achieve not only an excellent result in terms of robustness of process design, but also a very high acceptance amongst the future users of the methodology.”
This is how the team made of BTS IT Project Managers, Quality Managers, management representatives and Sanders & Associates jointly developed, in parallel to day-to-day responsibilities, the standardized SDS.Com Methodology: Present working processes were checked against current industry standards as well as GMP requirements and incorporated into the methodology body. Roles and process flows were standardized. Work packages were prepared for software projects by providing comprehensive templates and detailed working instructions.
In this context a modular setup of the methodology was established. Considering project needs, project managers can choose appropriate modules, and this way utilize pre-defined work packages straight from project initiation. This saves time and costs, while ensuring the high quality of the software solution.
Today, all high priority development processes have been checked and standardized by the team and assembled into the methodology release 1.0. Pertinent trainings in the development processes and their application have been conducted across Germany. Since it’s go-live in August 2014, use of the methodology is mandatory for all software development projects at Bayer Technology Service GmbH.
The methodology receives positive feedback from its users, and also Bayer Technology Services’ clients see the added value the methodology brings. Feedback from the projects is continuously sought and utilized to improve the joint methodology body. A release 2.0 is currently being developed, which will integrate additional working processes into the methodology body. The global roll-out is initiated.
„We are delighted that the methodology receives positive feedback from the teams, even more so, as the methodology lives and breathes in the teams, and continues to evolve“, Dr. Birsztejn and Dr. Sanders agree.
Dr. Thomas Birsztejn
Bayer Technology Services GmbH
Dr. Astrid Sanders
Sanders & Associates GmbH
Attributes of the SDS.Com Methodology
Sanders & Associates GmbH
Moltkestraße 13
27749 Delmenhorst
Germany
