Complying with FDA regulations takes more than one person in an office. Every person and every supplier needs to follow processes that are fit for purpose. Quality improvement must be part of the culture. And innovation must be carefully managed in order to protect patient and consumer safety.
Qualsys provides governance, risk and compliance management system software which takes the pain out of complying to regulations such as FDA. Our solutions make it much easier to properly plan, manage and control a wide array of business processes, from equipment maintenance to supplier records, risk management to internal auditing.
Plus, we offer free end users. This means every employee and supplier can see, interact and challenge processes within your management system – ensuring you have a strong, collaborative management system.
Your leadership, suppliers, and employees can access personalised to-do lists, customised KPI dashboards, and all activity in a single solution, so there are no shocks and suppliers when your auditors come knocking.
Qualsys’s software and solutions provides all the controls necessary to comply with the FDA’s requirement for managing electronic records and electronic signatures.
The system provides:
- Access control and user management to ensure the authenticity, integrity and confidentiality of electronic records.
- Secure, time-stamped audit trails to independently record the date and time of entries and actions that create, modify or delete electronic records.
- The ability to validate processes and configurations of the software to ensure your business consistently produces the right results.
- The ability to generate accurate and complete copies in both human readable and electronic forms suitable.
- Link electronic signatures to their respective electronic records.
- Allows only authorised changes to data and documents
- Ensures data integrity including: prevention of deletion, poor transcriptions and omission.
- Time stamped audit trails
- Disaster recovery / Back up and retrieval
- Use of Electronic Signatures where necessary
- Allows for system maintenance and change control
- Supports management of training documentation
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.