Ultimate™ Platinum
Comprehensive system security and a validated product have become essential requirements of a labeling solution for certain market sectors such as UK NHS Hospital Trusts, who must conform to the Medicines and Healthcare Products Regulatory Agency (MHRA). Similarly, pharmaceutical organizations, especially those operating globally, need to adhere to the US Food and Drug Administration (FDA) requirements contained in the 21CFR Part 11 standard for traceability of electronic records and signatures.
Ultimate™ Platinum contains all the features of Ultimate™ Gold plus enhanced security providing extensive password control and full auditing of every activity and event within the system, including the creation and printing of worksheets. Ultimate™ Platinum is MHRA and 21CFR Part 11 compliant and developed to GAMP standards.
As well as the validated Ultimate™ Platinum system, Episys provides IQ and OQ documentation to support installations who must demonstrate and certify the quality and reliability of the labeling system they use. Episys can also supply consultancy where required to help complete the on site validation process.
