Manufacturing Quality Management System (QMS)

A Manufacturing Quality Management System (QMS) Built for Innovation

AODocs’ QMS helps the world’s most innovative manufacturing companies improve their business processes, reduce human errors, guarantee compliance, and increase production flexibility. Attain and maintain compliance with ISO standards, Good Manufacturing Practices (GMP), FDA Title 21 CFR Part 11, and OSHA, accelerate product or service innovation, and keep your data secure. With AODocs, you can improve your manufacturing processes and increase collaboration with a user-friendly quality management system that makes it easy to suggest production line improvements, report incidents, and manage suppliers. That’s not all. You’ll also be able to expand your quality control, audit, CAPA, and bill of materials capabilities without breaking the bank.

Quality Control

Quality control involves many different policies and processes like employee training, testing procedures, defect reporting, and corrective actions. AODocs helps your company implement easy-to-follow processes that comply with ISO 9000 quality standards like ISO 9001: 2015 and ISO 13485.

With AODocs, you can make sure that your training documents, standard operating procedures, and other key quality control documents are up to date. You can also create comprehensive dashboards to identify operational bottlenecks and monitor KPIs to make sure that you’re continually improving quality and customer satisfaction.

By using AODocs to manage your documents’ full lifecycles with version control, rich metadata, publication workflows, and more, you can get and retain your ISO certifications. AODocs’ full audit log tracks all your document updates, making your audit and certification processes a breeze.

GMP Compliance

Get stable, controlled releases that won’t need any updates so you can stay GMP compliant. You won’t have to worry about any hotfixes after you’ve validated the latest version of AODocs. You’ll also get two-factor authenticated approval processes, post-processed audit logs, supporting documentation that comes with each new release, and technical support to keep you compliant and helps you validate your system faster. If you’re struggling to find the resources to validate your software, don’t worry. We can help with your validation processes too.

Standard Operating Procedures

Using outdated standard operating procedures can lead to costly mistakes, accidents, or even serious injuries. Make sure that your employees are always using the most recent version of your operating procedures. With AODocs, you can publish your standard operating procedures on the company intranet and send them to your employees’ mobile devices to make sure that they are only using latest version. Ensuring that your teams are following the right procedures helps you increase production efficiency, improve product quality, and avoid unnecessary risks.

If you need to make an update, you don’t need to remove your existing operating procedures. Change and edit your procedures while the existing version stays untouched. After you’ve published the new procedures, you can make sure that all your production lines are using it as soon as it’s released by tracking your operators’ training progress.

Change Requests

Have additional control over the documents that you rely on for your standard operating procedures, work instructions, and more. AODocs gives you a human-friendly way to manage change requests while still complying GMP and FDA Title 21 CFR Part 11.

With AODocs, team members are automatically notified when they need to approve a requested change. You can also monitor change requests and approvals while a post-processed audit log documents every change. These easy to access audit logs help your company avoid compliance issues and makes passing certification audits simple.

Incident Reporting

Provide your employees with easy-to-use tools to report incidents and defects. If you don’t, chances are that they will go unaddressed. AODocs is integrated with the collaboration tools that your teams use every day to make incident reporting simple.

With AODocs, an employee can report an incident using Workplace by Facebook. A workflow will notify the necessary department heads and automatically close or escalate the report when needed. Dashboards help you to process feedback and track all the incidents. That makes publishing post-incident impact reports and sharing company progress easy.

FDA Title 21 CFR Part 11 Compliance

Stay FDA Title 21 CFR Part 11 compliant with AODocs. No more time-consuming, paper-based approval processes. Now, you can quickly approve your GMP-related documents from your laptop or smartphone with a FDA-compliant electronic signature.

Save time by electronically approving documents while still meeting all your FDA compliance requirements. To stay compliant, you approve documents using two different authentication methods: Google authentication on your desktop and secondary authentication through a third-party mobile app on your smartphone.

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