The pharmaceutical industry is heavily regulated in relation to providing evidence of the conditions in which products are stored and transported. Regulations such as CFR 21 part 11, USP General Chapter 1079 and Health Canada Regulation 0069 all focus on the means by which environmental conditions, such as temperature and humidity, are monitored through the cold chain.
IMS has responded to the unique requirements of the pharmaceutical industry by introducing its EDX 1.0 solution, which is a fully validated and CFR 21 part 11 compliant application. Customers interested in the EDX 1.0 solution can purchase it with or without a validation package, depending on their requirements.
The EDX 1.0 solution is a fully scalable product that can grow to meet your changing requirements, as well as providing 24/7 secure on-line access to your current and historical results. EDX solutions also include user definable alerts and automated notifications of out of range conditions, when they occur.
In addition to the EDX solutions, IMS provides a number of related services, such as the temperature mapping of your storage and in-transit locations, to assist you in documenting detailed and localized variations in conditions, as well as to support your Quality Assurance programs.
For further information about IMS solutions, products and services, please contact us.