Flex Databases Certified to ISO 9001:2015

1. Customer Focus – Flex Databases’ Quality Management software helps companies meet customer requirements and strive to exceed customer expectations.

2. Leadership – Flex Databases helps companies unite their goals and create an environment where everyone works together to achieve the organization’s quality objectives.

3. Engagement of People – Flex Databases’ Quality Management and Document Control solution encourages a culture where everyone is skilled, empowered, and involved, improving the organization’s ability to create and deliver value.

4. Process Approach – Flex Databases ensure consistent and predictable results by managing activities as interconnected processes that work together as a system.

5. Improvement – Flex Databases’ Quality Management solution encourages customers to maintain an ongoing focus on improvement.

6. Evidence-Based Decision Making – With Flex Databases customers are better equipped to make decisions based on data analysis and evaluation, increasing the likelihood of producing desired results.

7. Relationship Management – Flex Databases ensures success by helping companies better manage relationships with interested parties, such as suppliers, sub-suppliers, and auditors.

The Quality Management System (QMS) offers centralized management of quality-related activities. Here’s a summary of its capabilities:

QMS Processes: Streamline all quality management processes within one system.

SOPs, Audits, Incidents, CAPA Management

• Manage Standard Operating Procedures (SOPs), audits (internal, external, vendor), incidents, and Corrective and Preventive Actions (CAPA).

• Initiate CAPA processes, including review, planning, and resolution.

• Manage audits comprehensively from planning to CAPA task resolution and observation periods.

• Register and track incidents, evaluating severity and impact, and monitor their resolution.

Customization and Configuration

• Customize workflows for QMS documents, audits, CAPA, and incidents.

• Create custom views, fields, and activities tailored to specific needs.

• Upload templates and generate audit-related documents such as plans, reports, and certificates within the system.

CAPA Management

• Initiate and manage CAPA processes, assigning tasks to responsible team members.

• Track responses and progress, monitor observation periods, and evaluate CAPA effectiveness.

• Generate documents and manage evidence of action implementation.

• Track various KPIs at company and project levels.

Audit Management

• Plan and schedule audits of various types (internal, external, vendor).

• Manage the entire audit lifecycle from planning through CAPA tasks to resolution and observation periods.

Incident Management

• Register and track incidents, assessing severity and impact.

• Monitor incident resolution, actions taken, and timelines.

• Make decisions on CAPA requirements based on incident assessments.

SOPs and Document Management

• Create and review QMS documents with revision history, electronic signatures, and transparency in the review process.

• Report on document review steps, responsible employees, and timelines.