Professional Services & Support

IQ confirms the system was installed correctly. OQ confirms it functions according to specification. PQ confirms it works in real life, for actual users and processes — against the client's own SOPs and worst-case data. Novatek executes IQ/OQ as part of every implementation; PQ is executed by the client, with Novatek assistance available.

Installation, IQ/OQ validation execution and generic system training are included, together with the installation guide, user guide and IQ/OQ validation documents including the 21 CFR Part 11 rationale. Process mapping, PQ documentation, data migration and client-specific training are Professional Services, purchased to scope.

Both are supported. Novatek can host and maintain the validated environment — the usual choice for virtual and lean organizations without internal IT — or the system can be installed on-premise within your own network and governance. The software, the validation approach and the support model are the same either way.

Yes. Multi-site organizations run a single instance that every site logs into, with data segregated by site and user role. Rollouts are sequenced site by site while configuration and reporting standards stay common, which allows best practice to be shared and performance compared across the network.

Process mapping documents the full process flow — sites, users, permissions, specifications, protocols, sampling, results, investigations, review and approval, reporting — alongside your SOPs and naming conventions. Worst-case data is then collected so PQ scenarios validate the system against how it will actually be used. It is the prerequisite for client-specific SOPs, work instructions, PQ documents and process-based training.

Yes. PQ scripts are written from the process mapping output, so they verify the software against your procedures rather than generic functionality. During execution, a Novatek validation expert can work alongside your executioner to provide immediate answers and avoid unnecessary deviations. Execution assistance requires process mapping and PQ document creation.

A feasibility study assesses the state and format of the existing data. Depending on that, the modules selected and internal priorities, Novatek recommends an automated transfer program, a manual exercise, or a combination. Automated migration includes mapping, script writing, script validation, test migration and final execution.

Hypercare is a defined, short-term period immediately following go-live during which support, monitoring and issue resolution are intensified to ensure the system operates reliably in the production environment.

A third party begins without system knowledge, which extends timelines and puts project cost at risk of exceeding budget. Delivered by the vendor, the work is scoped at fixed or contained cost with detailed system knowledge behind it — and the engagement is oriented toward using the system’s full capability rather than replicating an existing paper process.