Company Profile | December 12, 2000

Novatek International

Source: Novatek International
The Stability Program© is a software which manages the day to day activities of stability studies in pharmaceutical, chemical, biological, biotechnological and environmental industries. This software is designed for all types of products from pre-clinical to post market, innovator or generic.

The Stability Program© consists of Stability Program main window, Register, Protocol, Summary, Trend, Stability, Labels, Work load. The Stability Program in the Industry Stability testing is a routine procedure performed on drug products, active ingredients and excipients to understand the long-term effects of the environment on the drugs. It is used at various stages of product development. In the early stages, accelerated stability testing (high temperatures and relative humidity) is used to evaluate the stability of the drug and to determine what types of degradation products may be found after long-term storage. Testing under normal conditions (those recommended for long-term shelf storage) can be used to determine a product's shelf life and expiration dates. In these types of studies, the product is analyzed at predetermined intervals for various parameters.

1. Stability Organizer is the main window, which displays information regarding products in the stability program. The calendar grid in the upper portion of the window displays either a one-week or one-month view of products in the stability program. The name and packaging lot number are displayed for each product. The Date field is used to indicate the start date for which you want to view products. The lower portion of the window contains a grid, which displays the samples awaiting retrieval from their locations for testing.

2. The Product Registration windows are used to register information for each product in the stability program. This information is used to uniquely identify each product and to capture data critical to the stability testing process. The Product Registration window contains three subwindows for the following types of data: General and Packaging, Location and Other.

3. Protocol window is used to describe the general information about the product such as tests to be performed, type of stability, packaging and other information.

4. Summary window is used to record the results for each product being tested for stability.

5. Trend window is used to demonstrate the trend of the results for each product in the stability program.

6. Stability window allows user to write the SOP regarding the stability program.

7. Label window is used to print labels for each product in the stability program. 8. The workload window is used to establish and view the number of products and the workload in the stability program during a specific year. It can estimate the total testing hours and cost for each month of the year based on the information input by the administrator.

About Novatek:

Novatek International is a dynamic company that offers a broad range of consulting services. We provide high quality and cost-effective solutions to challenging problems. Our staff is a highly qualified group with extensive experience in software development, multimedia, Internet applications, graphics and technical writing.

Novatek International's consultants work closely with clients in order to determine their specific needs. Our certified engineers design and implement a complete solution for integration with the client's existing software. Throughout this process, clients are advised of our progress on a regular basis.