Stability studies software

Most comprehensive and easy to use stability studies management software
Most powerful statistic tools, complete sample tracking, out of the box and validated

Environmental monitoring software

Mobile environmental monitoring software
Real time trending, visual pattern recognition, automated investigation management, root-cause analysis, mobile and desktop app

Cleaning validation software

Achieve compliance and prevent regulatory issues
Risk based approach based on PDA technical reports 29 and 49, ISPE MaPP, 21 CFR Part 211.67, validation for cleaning processes (7/93), and EU Annex 15

team validating and training for pharma software

Fully Validated

IQ/OQ Validation Services
Training
Validation Documentation Package
URS, Design & Functional Specifications
Test Scripts
User Guides

implementing Qualification and SOP for pharma software

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.

we have been providing comopliant software solutions for 20 years

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, Cleanning 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)
pharma consultant providing Audit and Training services

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.

Organizations we work with

Upcoming Events

There are no upcoming events at this time.

Europe Headquarter

Address

19 Oliver Business Park, Oliver Road,
Park Royal, London, NW10 7JB

Phone numbers

+44 (0) 203 137 1820

Contact Us

We're not around right now. But you can send us an email and we'll get back to you, asap.