Numerous tools are available for Life Science firms, yet the eQMS stands as an indispensable system to secure regulatory compliance. It’s particularly adept at adhering to 21 CFR Part 11, which encompasses validation, timestamping, electronic record maintenance, and copies, along with 21 CFR Part 820, focusing on current good manufacturing practices (CGMP), particularly for medical devices companies.
The eQMS seamlessly integrates continuous updates of documents and processes, establishing comprehensive end-to-end traceability throughout the entire document lifecycle. Processes and project models are thoughtfully implemented to guarantee the solution’s validation.
A quality system for you and your company
The entire company can benefit from the extensive features an eQMS provides to enhance the organization and products continually. It encompasses document management, risk handling, training, audits, CAPAs, and support for various quality processes. The eQMS fosters alignment across the entire company and products, ensuring clarity about roles and responsibilities.
Here’s a simpler approach to engage colleagues beyond Quality Assurance in caring about the eQMS:
What’s in it for me:
Generate early engagement by asking employees across the organization, “What can enhance your daily tasks and make them more manageable?”
Knowing who does what:
An eQMS precisely identifies WHO performs WHAT tasks based on individuals’ roles in the company. This safeguards colleagues by restricting document access to designated permissions.
More accountability and transparency:
Observing when and who comments, offers input, or updates documents ensures complete traceability, accountability, and improved visibility.
Easy to administer and integrate with other systems:
Integrating the eQMS with other systems provides a comprehensive company-wide view, adding value and reducing costs.