Qualcy QMS

Qualcy QMS is a quality management software suite developed for life sciences companies, including biotechnology, pharmaceutical and medical device organisations. This listing highlights its audit management capability, which addresses the challenge of planning, conducting and documenting internal, supplier and regulatory audits in a highly regulated environment. Companies in these sectors must demonstrate compliance with FDA regulations, ISO 13485, ISO 9001 and good practice guidelines, and paper-based or spreadsheet audit records are difficult to control, search and present during inspections. Qualcy’s approach is to provide a validated, cloud-based quality system in which audits, findings and corrective actions are managed in structured workflows with full traceability, electronic signatures and audit trails, reducing administrative effort and inspection risk.

Audit management features include audit planning and scheduling, checklists, findings recording, assignment of corrective and preventive actions, and follow-up tracking until closure. The wider Qualcy suite covers document control, training management, CAPA, complaint handling, nonconformance management, supplier management, change control and equipment calibration and maintenance, all sharing common data so that quality events can be linked across processes. Dashboards and reports provide visibility into open actions, overdue items and quality trends, supporting management review. The system is designed with 21 CFR Part 11 compliance in mind, offering electronic signatures, role-based access and secure record retention. Qualcy is delivered as software as a service, reducing the need for local infrastructure and validation effort, and it is accessible through web browsers. Its target customers are small and mid-sized life sciences companies, start-ups preparing for regulatory submissions, contract manufacturers and laboratories that need to establish or modernise a quality management system without the cost of large enterprise platforms. Pricing starts from around USD 99, likely per user per month, with a free trial, and a free version is also available.