Episys

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. (See below for information on GAMP)

As well as the validated Ultimate™ Platinum system, Episys can provide an Installation Qualification (IQ) service at the time of the installation. A template is also available to enable the user to perform the IQ. Episys offer a consultancy service to perform Operation Qualification (OQ) and Performance Qualification (PQ) services on-site for Ultimate™ employing the test scripts used by our QA team to validate Ultimate™ for the OQ. A template is also available for organizations to perform the OQ.

Good Automated Manufacturing Practice (GAMP) is a trademark of the International Society for Pharmaceutical Engineering (ISPE). The ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. Over time, it has expanded from this role to become a major guidance for computerized system validation. One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product.