Fully Validated
IQ/OQ Validation Services
Training
Validation Documentation Package
URS, Design & Functional Specifications
Test Scripts
User Guides
Smooth Implementation
We Can Help You:
Paper to Software Audit (SIRA)
Process Mapping
SOP Document Creation
PQ Document Creation
PQ Execution Assistance
Quick Delivery
8 to 12 Weeks Delivery Fully Validated
Get you resources working asap
Novatek are global leaders in regulatory compliant software solutions from a LIMS Solution to individual Modular Apps.
About Novatek Europe
Our main objective over the past 20 years is to improve patient safety, we build our software expertise to produce solutions that reduce the risk associated with pharmaceutical manufacturing and contribute to product quality.
Novatek-Europe is a global leader in providing pioneering comprehensive, process driven software solutions, including stand-alone modules like: Environmental monitoring, Stability studies, Calibration and preventive maintenance, Raw materials and finished product management, cleaning Validation, Document & Training records management. All our software is 21 CFR part 11 compliant, our modules are out of the box solutions for quick and easy implementation for individual or multiple global sites.
Our Modules
Novatek Europe provides a new breed of all-encompassing, process-driven LIMS and other software solutions that target the pharmaceutical, biotech and other health-care industries.
Our unique portfolio of business ready, easy to use software solutions features specialized modules that help you manage all aspects of your quality environment with less effort and time.
Novatek delivers solutions that go beyond LIMS for total enterprise wide automation.
NOVA-CVM
Cleaning Validation Management Software
ENVIRONMENTAL MONITORING
Environmental Monitoring Management Software
ENVIRONMENTAL MONITORING MOBILE
Real-time Data Capturing to Secure your EM Sampling Process
UTILITY MONITORING
Utility Monitoring Management Software
NOVATEK DISEASE CONTROL & HYGIENE SOFTWARE
Saving Lives Through Better Data
NOVA-LIMS
Laboratory Information Management System
NOVA-STABILITY
Stability Management System Software
MATERIAL MANAGEMENT
Raw Material Analyzer | Finished Product Analyzer
NOVA-QMS
Quality Management System Software
NOVA-CPM
Calibration & Preventive Maintenance Management Software
VALIDATION
Validation Management Software
AUTOMATED PROOFREADER
Automated Proofreading Software
CONSUMABLE INVENTORY
Consumable Inventory Management Software
CLINICAL ASSAY
Clinical Assay Management Software
COLUMN ORGANIZER
Column Organizer Management Software
NOVA-INNOVATE
Innovation Management Software
NOVA-SCREEN CAPTURE
Quick & Automated Screen Capturing Software
Pharma Consulting
- Quality Management System design, implementation, review and update
- Inspection preparation
- GMP, GDP, RP, Rpi (Responsible Person (RSSL trainer) – MHRA and Cogent approved
- Computer System Validation
- Cold Chain Qualification
- Preparing for the QP viva in the UK
- Training (GDP, GMP)
GxP Temperature Q&V
We offer a range of Qualification & Validation services that are designed for a wide range of storage and transportation environments, and projects can be standalone to meet the expectations of individual requirements or can also include VMPs (Validation Master Plans) and various Risk Assessment options.
Join us with our Got 15 Minute Webinar Series to deliver quick and straight to the facts demonstrations on how to reduce your risk in:
– Environmental Monitoring
– Utility Monitoring
– Cleaning Validation
Organizations we work with
