In the field of life sciences, the evolution of software and standards requires a rigorous update of IS files. An organization undertakes the redesign of its processes and documents, in order to ensure more efficient and compliant management.
United Kingdom
Health and life science
GORTEC, a player in the life sciences sector, relies on several digital tools to manage its clinical and pharmacovigilance projects, including Cleanweb, Everdrug, Flex and Aquilab. Over the course of software updates and regulatory changes, these information systems have accumulated procedures that are sometimes obsolete and reference files that require in-depth revision. The objective: to align these documents and processes with current industry standards, while guaranteeing the integrity and traceability of sensitive data.
In this field, compliance is a major issue: any error or gap in data management can have significant repercussions, both in terms of regulations and on the quality of clinical results. Systems must be structured to ensure the security of information, the reliability of analyses and the fluidity of communication between the various parties involved. This update initiative also meets operational performance requirements, aimed at simplifying procedures and reducing the risk of errors or duplications. By engaging in this project, GORTEC is positioning itself to sustainably improve its data management and support the effectiveness of its research and clinical follow-up activities.
The updating of IS files must meet several requirements: make a complete inventory to identify gaps and inconsistencies, adapt internal processes to software and regulatory developments, and finally ensure better centralization and increased traceability of data. GORTEC also wants to ensure that its internal team assimilates the new procedures in order to perpetuate best practices and maintain compliance. The end goal: simplified operation and greater overall efficiency.
Centralize and make reliable critical information from various digital tools.
Integrate regulatory changes to maintain a high level of compliance.
Optimize clinical data collection and validation processes.
The intervention involves both a thorough analysis of the systems used and the redesign of the associated documentation. Support covers the entire update cycle: diagnosis, drafting or revision of documents, integration into daily workflows, and staff training. Particular attention is paid to data quality and security: each software must be configured and documented according to current standards, and each internal process must comply with the regulatory and transparency requirements specific to the life sciences sector.
Establish a precise diagnosis to target priority actions and shortcomings.
Revisit the protocols in order to better integrate quality and compliance requirements.
Involve internal teams for the sustainable adoption of new practices.
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