Data quality and trust in the data are essential for an organization.
Iperion can support in establishing and improving data quality
Iperion offers Data Services for Regulatory Information Management, Labeling and Change Control
Without proper data quality and trustworthy data, resources are spent to double-check information and no decisions on the information (e.g. reports) can be taken. Our team for managed services can support you in establishing and improving data quality. Whether from a one-time activity or as part of a continuous improvement program, our data experts can assist you in realizing trustworthy data, which is fundamental for achieving future optimization based on that data.
Information as a service
(Regulatory) Product information should in our view be considered a key asset for a pharmaceutical company and therefore managed as such.
In our highly regulated environment, data quality is key!
Achieving a high level of data quality and trustworthiness are essential for any organization. It requires subject matter expertise, experience and knowledge.
In addition, our team can assist you with incorporating the latest data requirements (e.g. ISO IDMP, PQ-CMC, TOM). We provide dedicated resources with the right capabilities and knowledge. This allows you to focus on strategy, development, innovation, while we guarantee data quality.
As part of our service, we re-engineer your data management processes to improve efficiency and maximize effectiveness, while simultaneously increasing the quality of your data.
We supply regulatory data services that keep you in control and in compliance of your products, in combination with our consultancy services.
Our offerings of Managed Services
Our experience has given us the ability to not only serve the needs of Regulatory Affairs, but also the internal consumers of this key information (e.g. Pharmacovigilance, Labeling, Publishing, Serialization management as part of Supply Chain). In addition, we are familiar with the external consumers and regulators who want to receive the data.
Our team can support you with the following topics and activities:
- Regulatory Information Management (RIM) / xEVMPD / SPOR / ISO IDMP Data Processing
- Data collection
- Data enrichment
- Data migration
- Data cleansing
- Data mapping
- Master data / controlled vocabulary management
- Data entry
- (Compliance) Reporting
- Labeling services
- Technical authoring
- Document migration
- Document Quality Control and proof reading
- Change Control
- Workflow management
- Compliance reporting
Our approach to Managed Services
- Jointly determine service scope, SLAs and KPIs, based on your needs and our portfolio of suggestions
- Train our dedicated team in your processes and create and/or update process documentation to ensure a standardized way of working
- Execute data services
- Continuously improve data service provision
- Identify and propose process improvements
- Implement data quality improvements
- Train/Educate stakeholders on data interpretation, system use, etc.
As part of this approach, we appoint a Service Delivery Manager (SDM), who will be the single point of contact and is the link to the services team. The SDM is responsible for the SLA’s and reporting of the KPI’s.
As our team operates your systems, we naturally provide Audit Support as needed.
Our dedicated teams
We work with dedicated customer teams. The way our consumer teams are staffed allow us to adjust the resource capacity according the workload. This flexibility enables us to meet stringent customer requirements.
Our services are provided via remote access by our team at Iperion’s headquarter in the Netherlands, Europe. If required, it is possible to scale up via on-site representation in the regions Asia and the US to ensure fast interaction and smooth service delivery.
Contact us for a free intake and we can explore how we can help you to reach predictable, controlled services.
Iperion delivers Services as a Value
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