The Environmental Monitoring Data Management & Trending System Software – The Industry Standard
It seems like just yesterday, when the Pharmaceutical Microbiology Forum Newsletter – March 2004, Vol. 11 (1) was published. One of the hot topics at the time was Environmental Monitoring (EM) and the question of the day was:
How many people are using software to capture and trend EM data?
The response was, “All companies use some type of software to evaluate EM data. Some indicated that they use LIMS but it is difficult to trend and the data must be exported to another program for graphing/trending purposes. Validating the exporting of the data to the other systems is also required…. Other companies indicated they are in the process of evaluating the software from Novatek. Others, who had already done so, were pleased with this product and its results.”
How the years fly by!
Eight years have passed since the first article about client satisfaction regarding the Novatek environmental monitoring data management and trending software product was published. Novatek’s Environmental Monitoring software has been extensively and positively discussed in several PDA publications and various magazine articles in that time. Since then Novatek has welcomed hundreds of companies, large and small, from all over the world. This has increased our global user group by thousands creating the largest EM software user group in the world! Throughout the Pharmaceutical/Biotech Industry members are proudly placing their experience with Novatek’s EM software application as one of their important skill sets listed in their resume. Companies are actively hiring microbiologists and environmental monitoring subject matter experts with Novatek’s Environmental Monitoring data management and trending software experience.
FDA then and now!
It has been eight years since the introduction of the famous Process Analytical Technology (PAT) and the FDA guidance on Pharmaceutical cGMPs for the 21st Century – A Risk-Based Approach, Final Report, 2004. These guidance publications were put in place to encourage utilization of modern and innovative technologies. The FDA has issued hundreds of citations regarding aseptic processes and handling of the environmental monitoring data management process and trending of data. More and more corporations are opting for automated software systems that will ensure they avoid the wrath of the FDA.
How far along have we come!
Eight years since the first Novatek environmental monitoring enterprise software version and 12 years since the first stand-alone Environmental Monitoring Program software were introduced to the pharmaceutical world, our development and engineering teams along with our customer support and quality department aided by industry subject matter experts, were combining their efforts and searching relentlessly, for new ways to improve the software and the electronic management of the environmental monitoring process as a whole. Every year we have brought new improvements and functionalities to our EM application.
In the last few years Novatek has made exceptional leaps forward by introducing several new features, process improvements and efficiencies that have substantially improved Novatek’s environmental monitoring software offering.
Features such as:
- “Dispersion Mapping” allowing for a visual across time view to what’s going on in your aseptic core and surrounding areas.
- Non Viable “Rolling Specifications” for enhanced specification level management of alert/action notification that allow for risk management and adverse trend predictions.
- Additional critical to quality trending selection and test disposition parameters that allow for traceability of products to their manufacturing environment and the equipment used in production.
- Additional trending selections for exceptional root cause analysis in the event of an excursion and the need to track microbial propagation in order to apply CAPA measures effectively.
- Easier raw data entry, review and approval of EM data sets using the rapid data entry access windows and electronic data feeds from particle counters and air samplers
- We have added even more reports such as Excursion Reporting and provided dynamic reporting tools to format the content of your reports.
- In 2012, we have enhanced our electronic bar code functionality, releasing the “Next Generation Bar-Coding” which provides a Total Paperless, FDA Compliant Automated Environmental Monitoring Process Software System and based on the current revision of USP Chapter 1116, which will be effective as of May 1, 2012, Novatek Environmental Monitoring will now include Microbial Recovery Rate Reporting.
Companies like PaxVax and Agensys Inc. in California, Westward Pharmaceuticals and Endo Pharmaceuticals in NJ, Novartis Animal Health in Canada, Hikma Pharmaceuticals in Germany, and Patheon in the UK are some of the newest Novatek software system clients. They join the ranks of our long standing satisfied clients such as Pfizer, Hospira, Abbott Vascular, DSM, Novartis, Cangene, Medtronic, JHP, Althea, Fresenius among hundreds of others.
How far are we going!
In eight years from now we will have evolved even further! Our promise to our clients and the industry at large is to consistently keep well informed of industry demands, regulatory requirements and manufacturing practices regarding the environmental monitoring process.
Our commitment is simple: Novatek will continue to improve EM software by increasing its efficiency and continuing to assist our clients’ with their compliance activities. We will help our clients improve and maintain a “State of Control” over their manufacturing environment.
We will proudly continue to contribute chapters to the latest PDA publications on Environmental Monitoring, as we recently did with Volume VI which is scheduled for publication later this year.
This year Novatek’s environmental monitoring software product, as well as our NOVA-LIMS suite of products, will be showcased in several major venues at major global events such as the PDA Annual Conference, the PDA/FDA Joint Regulatory Conference and the Annual PDA Micro Event, AAPS, and many IPA and Global Biopharma, Inc., events. We invite you to come view our latest versions and discover for yourself why Novatek’s EM solution is the industry standard in environmental monitoring data management and trending software.
We invite you to come visit Novatek at booth 512 at this year’s PDA Annual Meeting at The JW Marriott Desert Ridge Resort in Phoenix, Arizona Monday April 16th to Wednesday April 18, 2012!