Stability Sample Management System
Q1 Scientific is a stability storage facility, providing industry-leading temperature-controlled storage to manage sample inventory. Q1 offers services to the Pharmaceutical, Medical Device and Life Sciences industries, ensuring they meet the highest-international standards, as required for such highly-regulated industries. To provide the highest standard of sample management, Q1 Scientific relies on an Electronic Sample Tracking System, known as ESTS, to manage stability samples. Q1 developed this unique custom system to meet their specific criteria of sample management. The system was designed to be used to manage client study’s, sample set downs and returns; and as an inventory to track the location of samples.
When developing the system, it was vital that it be GMP-compliant and validated. To do so, Q1 developed a system that was:
- electronic signature compliant
- protected against data manipulation
- equipped to provide a full audit trail
The system is also password protected, with only Q1 Scientific employees given access rights.
Sample Management Process
When samples are received at Q1 Scientific, they are first thoroughly checked to ensure they adhere to client documentation. Once checked, ESTS is then utilised to process samples and they are ‘set down’ as per the client’s protocol, meaning they are placed in the conditions specific to each client’s requirements.
A new study number is assigned through ESTS to the client’s samples. Samples are then assigned a bar coded label, containing a unique container number, which is scanned into an available location. Through this container number, the samples can be easily located to their exact location. ESTS also ensures that samples cannot be placed in stability rooms which do not meet the client-specified storage condition. It does so by rejecting the scanning of these samples into an incorrect stability chamber.
All information relating to those samples are then documented on ESTS through this study number. This includes sample set downs and returns, and a sample register which shows the exact number of any batch currently on storage at Q1 Scientific. This ensures that the product life cycle of samples at Q1 Scientific is readily available to the client.
Client-specified calendar pull dates are also entered on ESTS, ensuring that the client will be notified by Q1 of all upcoming scheduled pulls. This information is then uploaded to the client portal website, where clients can access information for any study they have at Q1 Scientific, including a live calendar of upcoming pulls.