Satisfaction surveys, in addition to regular customer meetings, play a key role in defining new trends and helping us create innovative products. On such a sensible market, as is the pharmaceutical industry, impacted with numerous restructurations and structural changes, we have to adapt and propose new solutions designed to meet your expectations.
We have been working for several months now on our future software package HEM5 that will include new features but above all which is developed with a whole new perspective on studies environment and data analysis.
The 2012 satisfaction survey showed that you were globally very satisfied with our software and our services, as described in Newsletter #19, but also revealed that two of our services were still not well known or used: Validation and the Userspace.
Let us tell you more about them and how they can help save time on one hand and provide useful insights on the software on the other hand.
Validation: our experience on our products
NOTOCORD® provides two different services related to Validation:
- Consulting for the initial validation process of NOTOCORD-hem™ Evolution
- Assistance for validation of an upgraded version of our software
NOTOCORD® delivers complete service and documentation packages for compliance with FDA 21 CFR regulations. Our external consultant, a senior IEEE member, with more than 25 years of technical experience in FDA-regulated clinical and non-clinical environments, manages, schedules and performs the validation. She provides assistance for writing :
- User Requirements Specifications (URS)
- Standard Operating Procedures (SOP)
- Validation Plan
- IQ scripts
- OQ/PQ scripts (with user requirements)
Upgrade Validation Assistance
Our Upgrade Validation Assistance service is designed to speed-up and increase the efficiency of the upgrade process of NOTOCORD-hem™ software in a customer's GLP regulated environment. The flexible methodology is focused on key topics with an approach based on risk analysis and customization.
Formal tests are provided as Tests Statements and the tests protocol is executed with NOTOCORD® assistance.
Our target time for NOTOCORD-hem™ upgrade validation is 1 to 3 months based on an active collaboration between users, IT, QA and NOTOCORD® teams.
Userspace: "My NOTOCORD" at your service
Created 3 years ago to make up-to-date documentation available 24/7 for NOTOCORD-hem™ users, the Userspace My NOTOCORD has since been enriched with brochures, example configurations, tutorials, application notes and a very useful FAQ that is often considered as a first-line support.
Access is free but needs registration. Not registered yet ? Do it now !
And by the way, the Userspace also contains the full results presentation of the 2012 Satisfaction survey !