Complying with the FDA regulations requires more than one person in an office updating policies.
Every person and every supplier needs to follow processes that are fit for purpose. Quality improvement must be part of the culture. Compliance is a holistic, integrated approach. And innovation must be carefully managed in order to protect patient and consumer safety.
Qualsys provides quality management software which has helped 100’s of our customers to achieve FDA go-to-market approval.
EQMS by Qualsys bakes best practice into your employee’s daily routine and you have confidence all the compliance tools are working in the background. Compliance is natural, embedded and almost invisible for the end user.
EQMS doesn’t just enable you to have unshakeable control over any document, file or policy.
It’s an integrated management system tool which joins up your processes, embeds risk based thinking, enables the management of staff competency, and provides a framework for internal and supplier auditing.
For example, a business using EQMS may see a quality event in a laboratory. This is raised by an employee using Kiosk. Based on the information and data collected, this creates new record and job type in Issue Manager. This starts a workflow which sends notifications to the quality or health and safety team. This team can then investigate the root cause and send actions to employees in the system, update any documentation and send process changes to relevant employees for ‘read and understood’, schedule a new training record, update a risk register, and add the issue to any upcoming audits to check the corrective action was fit for purpose.
This holistic and integrated approach to quality and regulatory compliance builds a stronger, unified business. Your processes, policies and procedures become stronger because everything is connected. And when there’s an auditor, our customers say how they enjoy inspections because they know everything is there, compliant and recorded properly.
Complete access controls
The authenticity, integrity and confidentiality of electronic records is always protected in EQMS.
Incorruptible audit trails
Secure, time-stamped audit trails capture who, what, when, where, why and how a change has occurred.
FDA compliant electronic signatures and records
Demonstrate employees have read and understood changes, documents and policies.
Data integrity best practices
EQMS is built around ALCOA+ data integrity principles.
Complete validation package
From URS support to implementation to updating the software, we support your validation.
Demonstrate staff competency
Store certifications, training records, and examinations to demonstrate staff operating under the organisation are competent.
Don’t just take our word for it. Read our case study booklet to see the results we’ve achieved for businesses across the globe.
Learn about our five-phased approach to managing computer systems validation, and how we help you to comply with regulations and Standards such as ISO 13485:2016, GAMP 5, ICH GCP E6, FDA 21 CFR Part 11, Eudralex Volume 4 Annex 11, and the EU Electronic signatures directive.