Managers or Directors of Quality Assurance face many challenges in their important role. They must design, implement, and maintain GxP quality management systems, while ensuring that regulatory compliance requirements are met.
Beyond implementing Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), Quality Assurance Directors quite often must maintain substantial records, including databases, tracking systems, auditing documents, training records, and more. Every facet of the job must enact the highest standards for safety and audit readiness. With so much to oversee, Quality Assurance Directors need streamlined solutions for their many important tasks. Qualer can help.
Qualer Offers Quality Assurance Solutions
A Quality Assurance Director manages myriad aspects of the biotechnology business environment. As the title suggests, quality sits at the forefront of every goal. Remediation activities managed by a Quality Assurance Director include hosting regulatory inspections, reviewing data of clinical and commercial products so that all regulatory compliance standards are met or exceed, overseeing development, coordinating maintenance and calibration, and the list goes on.
How can Qualer help with these many intricate and crucial tasks? First off, as a Quality Assurance Director, you are a decision maker. As such, you must keep track of records and compliance documents, track changes, obtain electronic signatures. All of these tasks can be managed with the right platform. With Qualer, the power to do this in an up-to-the-minute fashion rests in your hands.
Qualer Specifics to Meet Quality Assurance Demands
What is Qualer, and how can we help you? Qualer offers a software platform that gives you a validated 21 CRF Part 11 solution right out of the box. With Qualer’s platform, you have accessibility into audit trails, you can manage vendor certificates as well as electronic/paperless certificates, and you can customize dashboard reports and analytical service reports.
Suppose you must oversee any equipment calibration. Qualer can walk you through a demo of our sleek, efficient, cloud-based platform to show you how your assets can have multiple maintenance plans. Those plans can be arranged on various time schedules, as your needs require. For each maintenance plan, we configure the specific test points, specifications, tolerances, vendors (whether internal or external), and other highly detailed fields. In this way, Qualer helps ensure that each of your assets receives the appropriate service at the right time.
One of your biggest asset or service event management challenges might be keeping data up to date for real time reporting and metrics. Qualer can help you with this, in addition to tracking locations of equipment and changes to status.
Additionally, Qualer offers audit readiness 24/7. You’ll receive automated recall alerts and other crucial notifications. You’ll experience complete transparency between your organization and service vendors. Our real-time Dashboard gives you instantaneous insight into your assets’ health. And to help avoid errors, our platform helps reduce your manual processes by 50 percent.
Welcome to Qualer: Quality You Can Trust
Qualer is a San Diego based company that offers a fully-validated asset, compliance, calibration, and service management platform designed to meet the evolving needs of regulated labs and facilities like yours. We are ready to help you excel in your Quality Assurance Direction. Contact Qualer today for a free demo!
