Auditing, GLP and regulatory compliance

Validated at sites worldwide

Comet Assay IV is used across the globe in many contract research and pharmaceutical environments where the need for a GLP-compliant system with robust auditing features is essential.

Comprehensive audit trails

Comet Assay IV has a wide range of powerful auditing and security features that are included as standard with the system:

  • generate in-depth audit trails that include details of every action performed by the users of the system.
  • forced user-defined reasons for actions, such as editing or deleting measurements.
  • automatically saves images along with measurement data whenever a cell is measured.
  • re-measure the comet from saved images.
  • perform quality assurance audits by comparing new data with historical.

To improve data security and regulatory compliance, we offer additional software programs and features which can be added to any Comet Assay IV package. Find out more about these packages and read more on the optional Data Extractor and System Access Manager programs below:

Secure data transfer with Data Extractor

Data Extractor

Automatically, Comet Assay IV will save data to protected Excel workbooks, however, you may wish to upgrade you Comet Assay IV system to connect to an Oracle database for secure storage of all measurement and audit data.

The Data Extractor utility gives:

  • extra data security using an Oracle database
  • authorised users can have the ability to browse all data within the database.
  • facilities to group, or filter, data on any combination of field values.
  • the ability to approve, reject and archive data in accordance with OECD guidelines.
  • export study data in Excel, XML and encrypted formats.

Data extractor allows for the ultimate portability and security of data. The integration of data into an existing data management system is easy and safe with Data Extractor.

Bespoke user management options with System Access Manager

System Access Manager

The Comet Assay IV system comes as standard with two accounts: a supervisor and a user. However, to achieve full compliance with the 21 CFR Part 11 rules, System Access Manager can be added to a system.

The System Access Manager utility provides:

  • full compliance with the FDA 21 CFR Part 11 final rule on electronic records and electronic signatures.
  • unique identification of each user.
  • the ability to add any number of users.
  • detailed person-specific audit trails.

Validation by global leading laboratories

Comet Assay IV has been validated to produce excellent, highly reliable accurate results at several of the world's leading testing genotoxicity laboratories.

Guidance is given through all stages of the validation process and we help by providing Installation Qualification (IQ) documents, pre-installation guidelines and any other relevant documentation prior to the installation.

Quality assurance

Comet Assay IV has also been comprehensively tested and validated in-house by Perceptive Instruments Ltd. in accordance with our stringent ISO 9001:2008 approved testing procedures.

All in-house project, test and validation documentation is made available to assist you with your own validation of the system.

Quotes

We're now using the software and it works great. It has cut our time for comets by at least half.

Post Doctoral Fellow, National Institute of Health, USA

We have had no problems so far, and we are very pleased with the system.

Senior Researcher, Public Health Agency, Finland

The system was set up last month, and so far it works very well. Both my boss and I are very satisfied with it and like it very much.

Researcher, University Hospital, Germany

...have been using it now for a couple of weeks and it seems to be working great. Very user friendly - I love it as does my intern!

Staff Chemist, Marine Laboratory, USA

Excellent, the training was very helpful and specific to in-house technicalities.

Lecturer, University, UK

We have installed the software and are using it without any problem. It's really simple! My PhD students are very happy with it.

Professor, University, Spain

It is actually working great.

Professor, University, USA

We are using the Comet Assay IV a lot (and our use is increasing). It's working very well.

Professor, Children's Research Hospital, USA

Perfect and very clear installation and training.

Study Director, Contract Research Organisation, Europe

Total change in our lab since you came (with Comet Assay IV of course...)! thanks... :-)

Postgraduate Researcher, University, France

We are very satisfied with your software.

Scientist, Cancer Research Institute, Slovakia

All is going well and the more I use the software the more I love the way it's so simple and intuitive...the comet software is running well and in increasing use.

Scientist, University, UK

We started using Comet Assay IV and it works well...

Researcher, Nuclear Agency, France

I'm really a fan of your system :)

Genetic Toxicologist, Global Pharmaceutical Company

I have been using the Comet Assay IV Software. It is great! During my software validation, I realized how much easier and precise it is compared to our old software. It makes analyzing the comet slides more enjoyable

Scientist, Medical Research Centre, USA

So it's working out fine and we're very happy!

Toxicologist, Health Agency, Canada

We are impressed indeed! It has saved us quite a lot of time and pains.

Director, Toxicology Research Centre, Spain

Yes, it is very useful and we are in the process of writing a paper also from the data derived from Comet Assay IV.

Assistant Professor, University, USA

...we are "happy users" of the software

Senior Researcher, Risk Assessment Institute, Germany

Thanks for your attention and great service. I am so glad that we have Comet IV.

Study Director, Contract Research Organisation, USA

We have found the Comet Assay IV software very useful and convenient.

Research Scientist, Food Safety Agency, France

Perfect and very clear installation and training!

Researcher, Contract Testing Laboratory, Europe

We are really very happy with the comet analysis system.

Research Scientist, University, Austria

The system is up and running. Everybody is impressed with the speed of scoring slides.

Researcher, University, South Africa

The current Comet Assay IV system works without any trouble…we are pleased with the system.

Scientist, Chemical Company, Japan

The Comet Assay IV system we already installed and is working perfectly.

Scientist, Environmental Institute, Norway

We have just recently utilized the system and are extremely pleased.

Assistant Professor, University, USA

Everything has gone very well with the system and we are very pleased with it.

Professor, University, UK

It is, indeed, much quicker than the old image analysis system that we had. We are very pleased with it.

Senior Researcher, Public Health Agency, Finland

Just to let you know we have started the validation study for Comet Assay IV and it has been going very well! We ran a comet assay last week and scored the slides with no problems at all. I am very pleased with the system and it will certainly make a difference when we run some comet studies this year!

Study Director, Food & Household Products Company, UK

Excellent, perfectly straightforward.

Scientist, University, UK

...and the system is running great.

Medical Researcher, Cancer Research Institute, USA

I don't have any questions about the software as it has worked quite well for us...so far we are very happy with the software.

Research Scientist, University, Australia

So far, I'm very happy with the system.

Research Lecturer, University, UK

...Everything is fine with the Comet Assay IV system...and I'm pretty happy about this new software with just clicking on the cells instead of drawing a frame around them

Researcher, Cancer Research Organisation, UK

I love the software. Keep up the good work over there.

Study Director, Contract Research Organisation, USA

The installation was quick and all the details were described and easily understandable for the technicians.

Head of Department, Global Chemical Company, Germany

It's an amazing program! Really useful!

Research Scientist, University, Brazil

We are very happy with everything, it is easy to work with your software.

Senior Scientist, National Health Institute, Portugal

Comet Assay IV software is in use. Currently our comet analysis is based on tail moment measurement and I must say that everything works properly.

Researcher, Cancer Research Institute, Slovakia

The system is working great.

Senior Research Scientist, Cancer Research Institute, UK

About Us

This site is maintained by Perceptive Instruments, industry-leading experts in image analysis for the comet assay.

We regularly attend comet assay workshops and contribute to the debate towards regulatory acceptance of the assay.

About Comet Assay IV

Comet Assay IV is the world's fastest, most consistent comet assay scoring system.

For our full range of products, head over to www.perceptive.co.uk