Flex Databases Certified to ISO 9001:2015

Jun 13, 2024
ISO 9001_2015

We’ve always been proud of our Quality Management System, which has been recognized by our clients during numerous audits and has helped us become a trusted vendor to regulated companies all over the world. Now, we have documented evidence – the ISO 9001:2015 certificate.

Flex Databases’ ISO 9001:2015 certification demonstrates its dedication to providing a comprehensive document control solution. 

The ISO 9000 family is a standardized set of guidelines for Quality Management Systems designed to help organizations ensure compliance with all statutory and regulatory requirements while also meeting customer needs.

Download The Certificate

The Main Principles of Quality Management in Clinical Trials

  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.

Flex Databases QMS

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.

Blog

6 Ways To Improve Clinical Trials Management 
6 Ways To Improve Clinical Trials Management 

Clinical trials play a crucial role in medical progress, yet effective management is essential to maximize their impact. Administrators must craft a thorough strategy to enhance how trials are managed. Here are five strategies to transform clinical trial management, providing administrators with the tools and insights needed to navigate healthcare research challenges effectively. Simplify planning […]

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Effective Site Selection Strategy
Strategies for Effective Site Selection and Management in Clinical Trials

Effective site selection and management are critical components of successful clinical trials. Choosing the right locations and overseeing their operations can significantly impact the trial’s timeline, budget, and ultimately, its success in delivering reliable data. This article explores essential strategies for optimizing site selection and management, highlighting key considerations, practical tips, and the role of […]

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How to Choose the Right eTMF System and Vendor

Handling a Trial Master File (TMF) can be tough for clinical teams, but it doesn’t have to be. Old systems with outdated file sharing methods or homemade systems with spreadsheets or paper can make managing sensitive trial data risky. Over the past decade, electronic Trial Master File (eTMF) systems have helped many biopharma companies and […]

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Top 10 Benefits of Modern CTMS for CRO’s
Top 10 Benefits of Modern CTMS for CRO’s

Clinical Research Organizations (CROs) operate in a dynamic industry where efficiency and adaptability are critical. As the global clinical trials market expands significantly, with forecasts predicting substantial growth, CROs face increasing demands to manage multiple trials efficiently across diverse projects and stakeholders. Legacy systems, still prevalent among CROs according to recent surveys, often fall short […]

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Get in touch to discuss compliance, implementation, demos, pricing

We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.