Novatek International

Nova-Cleaning Validation Management Software Pharmaceutical

4 / 5 4 reviews

Who Uses This Software?

Quality Management Quality Assurance Quality Control (includes microbiology and chemists) Managers and Supervisors (Pharmaceutical Labs) Validation Professionals Process Engineers

Average Ratings

4 Reviews
  • 4 / 5
  • 3.5 / 5
    Ease of Use
  • 4.5 / 5
    Customer Service

Product Details

  • Starting Price
    Not provided by vendor
  • Free Trial
  • Deployment
    Cloud, SaaS, Web
    Installed - Mac
    Installed - Windows
  • Training
    Live Online
    In Person
  • Support
    Business Hours
    24/7 (Live Rep)

Vendor Details

  • Novatek International
  • Founded 1996
  • Canada

About Nova-Cleaning Validation Management Software Pharmaceutical

Nova-Cleaning Validation significantly enhances product integrity by managing changes in the manufacturing process, equipment, product composition etc. and assessing the risks associated with cross contamination. With computerized risk-based worst case determination and fully automated MAC calculations the system is able to accurately execute hundreds of calculations in seconds instead of hours.


Nova-Cleaning Validation Management Software Pharmaceutical Features

  • Bills of Material
  • Financial Management
  • Inventory Management
  • Logistics Management
  • Manufacturing Execution
  • MRP
  • Product Configurator
  • Production Scheduling
  • Quality Management
  • Quote Management
  • Safety Management
  • Traceability

Nova-Cleaning Validation Management Software Pharmaceutical Reviews

stability management software

Jan 27, 2015

Comments: Want to buy this software

Stability Module

Oct 28, 2009
4 / 5
Ease of Use
5 / 5
Customer Support

Pros: This module is great for scheduling, tracking, and electronically approving stability test data. The trending feature and Arrhenius estimates of shelf-life have worked well for us, and several of our reports have been favorably reviewed by the FDA. Multiple lots can be selected to trend in the same graph.

The software also offers ample flexibility for creating individualized report formats.

Another nice feature is the modular construcion of the database which allows you to establish a number of different test protocols, which then can be selected for future studies without re-entering all of the specific details of the test plan.

Cons: (Changing a con into a pro): We knew at the outset that the module was not designed for multiplex data (Our DNA typing and Ab detection tests measure ~100 analytes simultaneously, with mixed high and low experimental values due to oligo probe or DNA sample variability, Ab avidity/titer and individual specificity).

Initially we utilized the software to analyze only selected parameters (expected positive reactions). Later, through in depth discussions with the Novatek technical and programming staff, we co-developed a customized approach to overcome these limitations. I think this will result in a unique analytical tool for trending and analyzing mutivariate stability data from complex assays using mutiplex platforms.

Overall: We have had a very positive experience dealing with all of the Novatek staff. They are very knowledgeable professionals, who make a concerted effort to satisfy customer needs.

Our IT department was impressed with the way they handled the software installation and IQ/OQ validations.

My technical staff found it easy to learn the basic use of the software, although we are still "discovering" tools that we did not notice at first. The Novatek technical representative has been extremely helpful whenever we asked for assistance, and especially in giving us different approaches to entering some of our unusual test protocols for easier data analysis.

Stability program is adequate and much better than nothing

Oct 06, 2009
2 / 5
Ease of Use
4 / 5
Customer Support

Pros: The fact that data are captured and cannot be altered without clear controls and documentation.

Cons: The fact that there is essentially no export or import features and that the report format cannot be modified.

Overall: Suggest that Excell and word output be more useful rather than work-arounds so that it looks readable in Word and Excell but can't be easily modified.

Novatek LIMS review

Oct 02, 2009
5 / 5
Ease of Use
4 / 5
Customer Support

Pros: very user friendly and function rich

Cons: we were overall satisfied

Overall: would recommend to anyone looking for Laboratory Information mangement system and Quality Management system