Valina is committed to improving the quality and compliance of IT GxP system by providing the following services but not limited to –
Let us help you to validate your GxP systems in Discovery IT, Clinical IT, Manufacturing IT, Drug Safety IT based on industry best practices.
Let us help you to validate your GxP systems in Discovery IT, Clinical IT, Manufacturing IT, Drug Safety IT based on industry best practices. We would follow your Policies and Procedures, SOPs and templates to construct a right-sized and risk-based validation package.
If you are not sure if your IT Systems need to be Part 11 Compliant, or when was the last time you did a Part 11 Compliance Assessment check. Valina's checklist prepared by its experts, would help you to conduct an as-is Part 11 compliance assessment and define a roadmap for you to succeed and be audit-ready.
Whether it's an upcoming regulatory audit, inspection, internal quality audit; we can help you to prepare with our checklist and determine the audit-readiness of your GxP IT systems.
Do you need to investigate, strategize for resolution and action your Audit action items. Or, due to a Periodic Review, Change Management - your validation package needs an overhaul. We would be happy to partner with you to remediate and close the action items successfully.
Having decades of experience in validating GxP IT systems according to established and industry-best Quality Management Systems (QMS) methodologies, we know what QMS would fit your company based on your size, GxP IT systems and their business criticality, resources, and overall exposure to regulatory authorities. We undertake a bottoms-up approach in understanding your documentation structure and then strategically build a robust and scalable framework.
SOP Development, Review, Archiving are the services that we provide to keep your QMS framework relevant. If you have recently taken over or merged with another entity, we can harmonize your SOPs and make it streamlined, centralized and accessible.
With increasing automation on the Manufacturing shopfloor, companies are needing effective validation strategies to manage the frequent changes to the equipment parameters, configurations, and managing data-capture systems. Our expertise in SCADA, MES, ERP and legacy IT systems would help you to keep validated your systems and also ensure Data integrity across applications.
Whether you have DI open action items, or want to conduct a DI assessment of your Laboratory IT or Manufacturing IT systems - our experts can conduct an extensive consultative approach towards Data Integrity assessment.