Services
Professional Services & Support
Software implementations stall on three constraints: resources, expertise and data migration. Novatek supplies the software and the services around it — process mapping, validation, training and migration — delivered by the team that builds the system.
Scoped engagements at fixed or contained cost, with resources available to your timeline.
Serving regulated life sciences since 1996.
- KickoffProject team assigned, responsibilities and timeline agreed
- Environment preparation & FATNovatek mirrors your environment, completes in-house validation and an installation dry run
- IncludedInstallation, IQ/OQ & trainingExecuted on site or remotely as standard
- Professional ServicesProcess mappingYour SOPs, naming conventions and worst-case data documented
- PQ creation & executionScripts written against your process, executed with an expert present
- Data migration & Go LiveManual or automated, followed by hypercare
What We Offer
Implementation
Structured rollout planning tailored to your systems, processes, and timeline.
Integration
Connect Novatek software with instruments, business systems, and third-party platforms.
Validation
Support for regulated validation requirements, including IQ/OQ processes.
Consulting
Expert guidance to improve quality, laboratory, and manufacturing workflows.
Training & Support
Role-based training and ongoing assistance throughout the software lifecycle.
Support Across the Entire Software Lifecycle
Novatek supports your organization from initial planning through deployment, validation, user adoption, and ongoing operation.
- PlanKickoff, project team, timeline
- ImplementInstallation and configuration
- IntegrateInstruments, ERP and QMS
- ValidateIQ/OQ executed, PQ supported
- TrainBy role, on your process
- SupportHypercare, then ongoing SLA
- PlanKickoff, project team, timeline
- ImplementInstallation and configuration
- IntegrateInstruments, ERP and QMS
- ValidateIQ/OQ executed, PQ supported
- TrainBy role, on your process
- SupportHypercare, then ongoing SLA
How Services Are Packaged
Three Tiers, One Delivery Team
Every implementation includes installation, IQ/OQ validation and system training. Professional Services cover the work that turns a validated install into an adopted system. Managed Services take the infrastructure off your plate.
Installation, Validation and Training
Delivered with every implementation, with the documentation your validation file requires.
- Installation and configuration
- IQ/OQ validation execution
- Generic system training
- Installation guide and user guide
- IQ/OQ documents with 21 CFR Part 11 rationale
Process Mapping Through Go Live
The services that make the system yours: your process documented, your PQ written against it, your data brought across.
- Process mapping — the prerequisite for everything below
- Client-specific SOPs and work instructions
- PQ document creation and execution assistance
- Data migration and hypercare
- Instrument and enterprise integration
- Process-based and client-specific training
Hosting and Ongoing Operation
Novatek hosts and maintains the validated environment so your team runs the process, not the infrastructure.
- System hosting
- Environment maintenance
- Proactive monitoring
- System account management
- Multi-level SLAs, up to 24/7 technical support
Deployment
Hosted by Novatek, or on Your Own Infrastructure
Deployment is a commercial and IT decision as much as a technical one. Both options run the same validated software and carry the same compliance posture.
Novatek-Hosted Cloud
The environment is provisioned, maintained, monitored and backed up by Novatek. Suited to virtual and lean organizations with no internal IT function, and to manufacturers who would rather not add a validated server to their estate.
- No internal server infrastructure required
- Environment maintenance and proactive monitoring included
- Qualified infrastructure supporting your validation
Installed in Your Data Center
The system runs inside your own network under your IT and QA governance — the established route for manufacturers with existing infrastructure, internal hosting policy or data residency requirements.
- Full control of servers, backups and access
- Fits existing IT change control and DR arrangements
- Thin client deployment across sites
Same Software, Same Validation
The choice does not change the product, the validation package or the support model. Organizations frequently start on one and move to the other as IT policy evolves.
- Identical functionality and documentation set
- Same IQ/OQ approach in both models
- Migration between models supported
Global Rollouts
One Instance, Every Site
Multi-site organizations run a single Novatek instance that every site logs into, with data segregated by site and by user role. A global rollout is sequenced site by site while the configuration, specifications and reporting standards stay common.
The advantage is not only technical. Once every site works in the same system, a practice that works well in one plant becomes visible to the rest — and quality leadership can compare performance across the network instead of collecting spreadsheets from it.
Single Global Instance
Every site logs into the same system, with data segregated by site and user role.
Sequenced Rollout
Sites brought live in phases, with each deployment informed by the last.
Shared Best Practice
Configurations and procedures that work at one site are identified and applied across the network.
Global KPIs
Performance compared across sites from one data set rather than reconciled between systems.
Market-Specific Release
Product released to specific markets within the same global configuration.
Partnership Approach
A dedicated project coordinator, defined responsibilities and milestones, and a timeline built around your commitments.
Services in Detail
Everything an Implementation Requires, From One Team
Process mapping is the keystone: client-specific SOPs, work instructions, PQ documents, execution assistance and process-based training all build on it.
Process Mapping
Your process flow, SOPs and naming conventions documented, and worst-case data collected to build PQ scenarios against.
SOP Creation
Generic or client-specific SOPs for operational use and system administration, aligned to your internal procedures.
Work Instructions
Step-by-step, screenshot-level task guides that reduce variability between users and support competency assessment.
PQ Document Creation
PQ scripts that verify the system against your procedures and worst-case data, not generic functionality.
PQ Execution Assistance
A Novatek validation expert alongside your executioner, giving immediate answers and avoiding unnecessary deviations.
Data Migration
A feasibility study first, then the most secure and economical route: automated script, manual transfer, or both.
Hypercare
Intensified support, monitoring and issue resolution through the first weeks of production use.
Instrument Integration
Interfacing lab instruments, monitoring systems and enterprise software such as SAP so results arrive without transcription.
System Configuration Documents
Every configurable option recorded in a controlled template, signed off and maintained by your administrators.
Software Assessment
An on-site review once you are live, returning a report of the features, reports and analyses you are not yet using.
Managed Services
Hosting, environment maintenance, proactive monitoring and system account management.
Training
Super user and end user programs, generic or matched to your documented process, delivered by role.
Training
Training Built Around Your Process, Not Ours
Users can learn what a system does and still not know how their process fits inside it. After process mapping, training is delivered against your documented workflow — so the first day of live operation is not the first time anyone has seen it.
- Generic system training — five days, typically four on site and one remote Q&A
- Extended training — super user and end user programs, four days each
- Client-specific training — matched to your process after process mapping
- Three-step method: demonstration, hands-on, question and answer
- Delivered by role, with data integrity built into every session
- Training certificates and sign-off for your validation file
Typical Duration
- Generic system training
- 5 days
- Super user training
- 4 days
- End user training
- 4 days
- SOP review (remote)
- 5 days
- Process mapping
- 5 days
Why the Vendor
The Team That Built the System Should Implement It
A third party learns the software on your budget and your timeline. Novatek's specialists already know it — engagements are scoped at fixed or contained cost, resources are available when the project needs them, and the goal is that you use every capability you bought rather than moving a paper process onto a screen.
A Partner You Can Count On
Implementation and Validation Services: Frequently Asked Questions
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.
Plan Your Implementation
A scoping conversation about your timeline, your validation requirements, your deployment model and the resources you have available.