Quality Management System (QMS) for Life Sciences

A Life Sciences Quality Management System (QMS) That Simplifies Compliance

Whether your company works in the medical device, biotech, or pharmaceutical industry, the bottom line is that, for life sciences companies, quality and compliance is everything. In these regulated industries, a single mistake can make or break a company. AODocs helps you simplify your GxP and FDA Title 21 CFR Part 11 compliance processes, innovate faster, and keep your data secure. AODocs’ user-friendly enterprise quality management system makes documents easy to access and share, you’ll be able to streamline your business processes and release your products or services more quickly.

Eliminate Human Error

In the life sciences industry, innovation is essential to staying ahead of the competition. Give your team a user-friendly quality management system that allows your team to spend less time managing test procedures, audits, and CAPAs and more time creating innovative products and services.

More Control

Have more control over the critical process documents that you rely on for your standard operating procedures, work instructions, and more. AODocs helps your company avoid compliance issues and process disruptions by giving you a human-friendly way to effectively manage change requests in a GxP and FDA Title 21 CFR Part 11 compliant way. With AODocs, you can automatically notify team members when a change has been requested and needs to be approved. You can also monitor change requests, get statuses, and approvals while a post-processed audit log documents every change. During compliance audits, you have easy access to all your request logs to show the auditors every update.

GxP Compliance

Stay GxP compliant with two-factor authenticated change request approvals, post-processed audit logs, and technical support. You’ll only receive stable, controlled AODocs releases that won’t need any updates. So, no need to worry about any hotfixes happening after you’ve validated your latest version of AODocs. You’ll also get supporting documentation along with every controlled release for easier system validation. If you find that you don’t have enough time to validate your software, we can also help you with your validation process.

FDA Title 21 CFR Part 11 Compliance

Be Food and Drug Administration (FDA) Title 21 CFR Part 11 compliant with AODocs. Say “goodbye” to slow, paper-based signature processes. With AODocs, you can quickly review and approve your GxP-related documents with a FDA-compliant electronic signature. Using two-factor authentication, you can save time and improve productivity by electronically approving documents while still meeting all your FDA compliance requirements. Users approve documents with two distinct authentication methods: Google authentication on their desktop and secondary authentication through a mobile app on their phone.

Data Integrity

Making sure that your data hasn’t been changed or lost is important if you want to stay FDA compliant. With AODocs and G Suite, the most secure cloud platform, you can be sure that your data will be safe. AODocs allows you to maintain a complete, attributable log of all your data. Store and track document metadata throughout document lifecycles so you can reconstruct all your documents’ activities. So, you can be sure that you’ll be able to pass your GxP compliance audits.

Business Insights

Get a global view of your documents, their workflow statuses, and user activity with comprehensive dashboards. Quickly identify problem areas in advance of an audit, track progress, and identify bottlenecks in your processes to keep things running smoothly.

Validated Application Modules

Reduce your validation costs with standardized application modules for audits, CAPA, bill of materials, and more. Even better, AODocs’ application modules come with all the validation documentation that you need so you can get your system validated faster.

Learn Even More

What is ISO 9001?

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Success Story: Essilor

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What is GxP?

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