We understand the big picture
There are many factors that are driving increased adoption of technology in life sciences such as increased regulatory scrutiny and traceability requirements, personalized medicine and globalization. There have also been significant advances in technology itself over the last decade with mobile computing and the cloud. Life sciences organizations who adopt new technology can gain significant benefits and competitive advantage in doing so, however, this can pose certain challenges in a complex and regulated environment such as ours. Making sure that we have a coherent and holistic technology strategy across the business is key to properly integrate data, processes and technology in today’s pharmaceutical environment. Montrium can help.
Our Technology Strategy Services
Montrium’s knowledge of GxP processes coupled with its in-depth knowledge of the different systems within the pharmaceutical landscape enables us to work with your team to implement a coherent GxP IT and Technology strategy. Our Technology Strategy services focus on minimizing risk and aligning technology with your existing processes and corporate development plan.
In conjunction with your local teams and key personnel, we can perform an in-depth Gap Analysis of your existing environment and processes in order to define a clear technological road-map in the form of a strategic plan. This plan will focus on standardization and improvement of processes, integration of new and existing technologies, meeting regulatory requirements and improving quality.
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Business Analysis Services
We use our in-depth knowledge of GxP systems and business processes to offer a series of different business analysis services to help you evolve your technology stack and leverage technology to improve operations or gain competitive advantage. These services include:
When selecting vendors and computerized systems, it is imperative to ensure that the team has a clear understanding of their requirements. By formally defining requirements, not only are we able to set criteria for vendor selection which are based on exact needs but also avoid costly mistakes once the vendor has been selected.
Montrium’s team of experts is able to work with your operational teams to define clear user requirements which are aligned to your processes and regulatory requirements. To provide a requirements baseline and accelerate the requirements definition process, we offer pre-defined sets of generic user requirements for specific GxP systems such as EDC, CTMS, PV and ERP. These pre-defined requirements are based on industry and regulatory standards and can be adapted to your organizations specific requirements.
SharePoint Services
When used in the context of regulated activities, it is important to validate SharePoint in order to demonstrate the system is fit for its intended use. Montrium has extensive experience validating SharePoint as a result of numerous implementations for our customers in the life sciences industry.
The Montrium team can work with you to adapt our standard governance plan template to your organization. With proper planning, the management and governance of your SharePoint environment can be greatly simplified. This approach also ensures that the SharePoint environment is maintained in a controlled and compliant state.
Our Governance Plan covers the following high-level areas:
- SharePoint governance roles and responsibilities
- Management of user access rights and security
- SharePoint site standards
- SharePoint site administration
- Configuration and change management
- Information management and architecture
- Application management
Montrium has helped numerous customers in the life sciences industry implement SharePoint, from small/medium size biotech companies to large multi-national pharmaceutical companies. By combining our technical expertise with our understanding of the business needs and best practices, we are able to develop a strategic plan that is tailored to each one our customers.
Careful planning and well-documented decision-making are integral to Montrium’s approach. When developing a corporate strategy to implement SharePoint it is important to look at the big picture and identify how best to structure the environment while taking into consideration key factors, including:
- Security and accessibility
- Compliance with regulations
- Corporate taxonomy
- Business process optimization
- Integration with other systems
- Scalability and performance
Sometimes you just don’t have enough resources to manage internal environments or you are just starting out with SharePoint and need some additional support. Montrium can help with its Managed Services. As a Microsoft Gold Partner, our technical and client support team are all certified in core Microsoft technologies including SharePoint. Our team is able to provide our clients with managed services to provide oversight for part or all of your regulated SharePoint farms. These services can be provided in line with your own internal procedures or by using Montrium’s procedures for maintaining the validated state and governance of your SharePoint environment. Services that we provide include:
- Maintenance of SharePoint user accounts and groups
- Provision of end user and administrative training
- Additions and modifications to configuration including new sites, content types, metadata columns, list items and system parameters
- Management of tier 2 and 3 issues and bugs
- Development and execution of change control documentation
- Development and maintenance of configuration specifications
- Review and impact assessment of system changes / patch application by the local system admin team
- Other system change / configuration management activities
- Content migration & legacy system decommissioning
The above services can be provided for your on-premise or Microsoft’s Azure environment. Other services may also be available upon request.
