MHRA and 21CFR Part 11 validated products including IQ/OQ
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.
Enhanced security is a major component of Ultimate™ providing extensive password control and full auditing of every activity and event within the system. Ultimate™ is MHRA and 21CFR Part 11 compliant and developed to GAMP standards.
Episys also provides a range of Validation Products and Services that can assist to ensure accuracy and to save time. These services include not only validation documentation but also validation services by experienced engineers.
Validation Certificate
A Validation certificate is available that confirms the tests that have been performed to demonstrate that the product is “fit for purpose” and meets its specification.
A Validation certificate is available that confirms the tests that have been performed to demonstrate that the product is “fit for purpose” and meets its specification.
Validation Folder
The Validation Folder contains a complete documentation set covering the specification and test scripts for the product. The folder contains hard copies of the completed test scripts showing the full test results.
The Validation Folder contains a complete documentation set covering the specification and test scripts for the product. The folder contains hard copies of the completed test scripts showing the full test results.
Installation Qualification (IQ) Service and Document
The correct installation of a product is critical for any controlled labeling environment. This package provides an experienced installation engineer to install the product, perform the initial set-up and carry out testing. An IQ report is completed to document the installation and initial settings.
The correct installation of a product is critical for any controlled labeling environment. This package provides an experienced installation engineer to install the product, perform the initial set-up and carry out testing. An IQ report is completed to document the installation and initial settings.
Operational Qualification (OQ) Master Test Scripts
Demonstrating the correct operation of the labeling solution within a company’s standard operating procedures can be a time consuming task before a system can be put into use. The OQ Master Test Scripts provide a complete set of tests that can be performed to check the correct operation of the product. The customer can tailor these scripts to test any set of operational requirements.
Demonstrating the correct operation of the labeling solution within a company’s standard operating procedures can be a time consuming task before a system can be put into use. The OQ Master Test Scripts provide a complete set of tests that can be performed to check the correct operation of the product. The customer can tailor these scripts to test any set of operational requirements.
Validation Services
The standard products outlined above can be augmented by consultancy to assist with understanding and configuring any required environment.
The standard products outlined above can be augmented by consultancy to assist with understanding and configuring any required environment.
Key features and benefits:
- Standard Validation documentation saves time and money
- IQ Service ensures a product is correctly installed and configured
- OQ Master Test Scripts ensure coverage of all product functionality
- Validation Services can be used to assist internal QA departments