Services: implementation expertise and business knowledge

Pharmaceutical and life sciences companies face challenges that require more than IT expertise. They want services based on experience meeting industry, business, and technology challenges.

Our solutions and services leverage technical knowledge and deep understanding of the competitive landscape in the pharmaceutical and life sciences industries. This firm foundation enables us to help our clients successfully introduce the right business processes and ensure that those processes are supported by the right solutions. Our services include:

 

  • Enterprise Architecture
  • Solution Assessment
  • ERP Implementation through Certified Partners
  • Project Management
  • Computer System Validation

 

Integrating and organizing processes, data, and technologies for Pharmaceuticals and Life Sciences

The ideal approach to Enterprise Architecture in Pharmaceutical and Life Sciences projects should enable the business to meet rigorous requirements and improve productivity, compliance, and quality.

We work closely with our Customers and Partners to deliver methods and organizing principles that align industry-specific objectives and strategies with an IT strategy and execution plan.

Our goal is to ensure that our Clients realize and sustain an integrated, standardized business-operating model and systems architecture. We have the domain and technology expertise to help our Customers map out an optimal business and IT structure and successfully transition to an enhanced or new architecture.

Identify opportunities for generating additional value from the solution in use.

ERP Solution Assessment can empower Pharmaceutical and Life Sciences organizations to develop a road map to align with changing business objectives.

Our industry and AX for Pharma consultants work together with Microsoft Dynamics 365 experts from our Certified Partners in order to evaluate our clients' existing technology and understand how it can play an integral role in improving business processes. After assessing customers' business situation, we offer recommendations and assists in implementing the industry-specific solution that is right for the organization.

Our system assessment approach uses a combination of top-down (issues-driven) and bottom-up (direct observation) analysis conducted via workshops attended by relevant business process owners.

Delivering pharmaceuticals and life sciences expertise through a global network.

Implementing an ERP solution in pharmaceuticals and life sciences companies requires a team of experts who understand your business and how technology supports industry-specific processes.

We can provide that expertise with a worldwide network of Certified Partners. They have the experience and credentials needed to implement industry ERP that meets local, regional, and global requirements.

We also provide ERP upgrade and migration services,helping to transition heavily customized solutions based on older ERPs (including older versions of Microsoft Dynamics AX) to the most recent, standardized technology based on Microsoft Dynamics 365. We can support clients that are planning major business process changes or restructuring their business model. With our advice and support, our clients can replace complex and customized ERP applications with the latest version of our industry-specific, integrated and compliant solutions.

Guidance, leadership, and support that drive quality and profits.

Project management is critical to running successful projects or large scale programs: cost containment, sustainability, growth, and profitability all depend on precise planning and execution.

Our project management experts can help guide, lead and support your programs and project initiatives across highly regulated areas, where compliance, technology and business intersect.

Our project management model is based on the proven Microsoft Sure Step methodology. The model enables us to deploy industry best practices based on processes that are standardized, quantified, and optimized, which in turn ensure consistent and repeatable results.

Ensuring IT systems are fully compliant to Pharmaceutical and Life Sciences regulatory requirements.

Computer system validation has been a fundamental requirement since many years in the pharmaceutical and life sciences industries.

We have experience with formulating compliance strategies for both large and medium-sized pharmaceutical and life sciences companies. Our expertise enables us to scale compliance strategies to suit any business balancing risk, cost, and compliance. Our approach to the Computer System Validation meets the highest industry standards.

By working with us, our Clients can achieve:

  • GxP compliant ERP systems and processes
  • Compliance with FDA, EMA regulatory requirements and guidelines (21 CFR part 11, Annex 11, GAMP 5)
  • Sustainable reduction in cost of the Computer System Validation effort
  • Security for internal and external audits
  • Validation strategy to implement GAMP 5's risk-based approach