At Q1 Scientific we maintain an extensive Quality Management System (QMS) to control and manage every aspect of our sample storage and management service.
Catherine our Quality Lead has been working behind the scenes to deploy an electronic QMS. Moving away from a manual Excel and Word-based process to an automated, cloud-based QMS allows the entire team to collaborate seamlessly with a full digital record of all activity.
Here Catherine tells us more about why we moved to an online QMS.
What is a Quality Management System?
A Quality Management System is a formal system for documenting processes, procedures, and responsibilities within Q1 Scientific to achieve quality objectives and meet both customer and regulatory requirements.
At Q1 Scientific, we use a QMS to coordinate and manage all sample storage and management activities. The QMS helps us to achieve and maintain regulatory compliance and keep up with market demands.
Why did Q1 Scientific move to an electronic Quality Management System?
While a paper based QMS was fine when the company was smaller, we had got to a point where we needed to automate the process to improve productivity. The paper based QMS was a very time consuming and manual process with stamping, indexes and tracking spreadsheets.
Another key driver for moving to an eQMS has been the rapid growth of Q1 Scientific. The last number of years has seen Q1 Scientific go from 6 stability rooms to over 50 rooms with a 900% increase in storage capacity. Client numbers have also grown, and we now look after samples for a large portion of the 20 biggest pharmaceutical companies in the world. In addition, the Q1 Scientific team has grown by 50% over the last year with additional team members across accounts, quality, operations and marketing. You can understand now why we needed to introduce an eQMS!
Additionally, although Covid-19 has changed our world, the requirements for a QMS have not changed. Many of our customers are continuing to work remotely for the foreseeable future. Therefore, to meet customer needs and our own business needs it was important to transition to an eQMS.
Having a cloud-based quality system that is accessible from anywhere, any time and on any electronic device, enables continuous engagement between our employees, teams and customers without the need to meet face to face or be located on site. The transition is important for communications, collaboration and information sharing while dividing time between the site and home office.
What are the benefits of having an eQMS?
There are some obvious operational and continuous improvement benefits to having an eQMS. Although paper-based processes have been the standard for decades, they are more time consuming, prone to human error and require someone to be physically located on site. Some of the key benefits of the new eQMS include the ability to track activities with full traceability and reporting functionality such as:
- Document Management
- Change Control
- Quality Events
- CAPA Management
- Risk Assessments
- Customer Complaints
- Audit Management
- Supplier Management
With the new eQMS we are eliminating non value add activities so that we can spend more time on value add activities. There are a number of projects in the pipeline for the quality team and with an automated system we have created more time to deliver on those projects.
Lastly, it’s another measure for mitigating regulatory risk. Managing regulatory risk, compliance, and certification are critically important objectives for our Quality team.
Does the new eQMS meet regulatory requirements
Yes, the new eQMS is fully compliant with 21 CFR part 11, EU Annex 11 and supports ISO 9001, 13485, 14791 and 27001.
In addition, we have completed full system validation checks for compliance.
How will Q1 Scientific customers benefit from the new eQMS?
With a single dashboard, the new eQMS manages all aspects of quality throughout the sample storage life cycle.
The rise in the use of Zoom and other digital tools during the Covid-19 crisis really highlighted for us the importance of having digital communication tools and systems available to support customer business continuity.
Traditionally our customer quality audits, and regulatory inspections have required an on-site presence. Covid-19 changed this dynamic with all our customers opting to conduct remote audits. Our new eQMS is perfectly suited to delivering remote audits as all information is readily available online. It’s a highly secure system and we can provide restricted and controlled access to outside auditors for specific information sharing or to engage remote employees to address audit findings in real-time regardless of their location.
In addition, documentation requiring a signature can be signed digitally and returned immediately.
Finally, it’s easier to filter and find information required by customers.
Would you like to find out more?
Overall, embracing change and utilising an eQMS enables Q1 Scientific to be well prepared for what the future holds while continuing to meet customer needs.