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Document Control Goes Paperless

In the regulated environment, if something is not documented, it didn’t happen. Quality operating procedures and regulatory compliance entail proper documentation. This includes new documentation, updates, reviews, and approval of procedures and any changes in those procedures. The need for electronic document management is a foundational requirement that touches all quality management processes.

If you still use paper-based or unconnected legacy systems, you’re likely spending too much time and effort manually routing, obtaining approval, submitting changes, and conducting meetings to discuss those changes. Separate systems for document control, training, CAPA, audit, and other quality processes increase the likelihood of miscommunication, duplication, errors, and quality tasks falling through the cracks.

AssurX automates document control, including routing, review, revision, and approval of documents. It makes both quality management by supervisors and participation by users easier throughout the document lifecycle with robust notification, revision, escalation, and approval features. The system provides a centralized, secure repository for convenient search and checking-in/checking-out of documents by authorized users throughout the enterprise.

AssurX Document Management Solution

Watch a 12 Minute Video of the AssurX Document Management Solution Now

See how the AssurX Document Management Solution creates an easy-to-access and control electronic library that manages the entire document lifecycle from creation through obsolescence including collaborative authoring; changes; approval routing; release; notification and training.

Learn how one combination product manufacturer built the foundation of their QMS with AssurX Document Management and Training Management Solutions

AssurX Case Study: CDMO built the foundation of their QMS with AssurX

How AssurX Quality Document Management Software Can Help You

More and more regulated companies are realizing the value and necessity of quality document control software to improve quality operations and facilitate compliance. Organizations with some of the most rigorous regulatory requirements rely on AssurX to manage the five phases of the document control lifecycle seamlessly.

Benefits of Using AssurX Quality Document Management Software

Shorter Document Control Cycle Time

An end-to-end approach to CAPA actions provides significant compliance advantages. If process gaps are found at any time during the CAPA process, a change record can be launched. If documentation needs to be updated, AssurX Document Management gets the revision completed and approved, and can trigger a training task.

Centralized Document Management

Users across your organization will go to one source for all documents they need for compliance. Come audit or inspection time, you’ll be confident that regulators will be able to find documents they need in the same place.

Risk-Based Approach to Compliance

AssurX integration connects document control to any other process including training management, CAPA, audit management, risk management, supplier quality, and others for a holistic approach to compliance. Under this approach, documents that require training or affect other quality processes will seamlessly launch related tasks in those processes. AssurX is designed based on best practices and risk management principles that can be found in such standards as ICH Q9 for pharmaceutical companies and ISO 14971 for medical device firms.

CORZA Medical uses AssurX for Document Management and overall QMS

“AssurX has allowed our facilities to become much more organized and efficient by having all pertinent information, scanned documents and photos in one location is key for a successful business and audits.”

AssurX: Quality & Compliance Systems for Every Enterprise

When you choose AssurX, you’re choosing decades of expertise in regulated environments and continuous innovation in quality management. Our unwavering focus on quality management means you’re getting a best-of-class solution, not a scaled down or inflexible software solution.

One Platform. Every Solution.

Seamlessly integrate all quality and compliance management processes with one software system. Start by using just the solutions you need now, then easily add more as you are ready. No other system is easier to deploy, configure, and modify.

Audit Management

CAPA Management

Calibration Management

Change Management

Complaint Management

Customer Quality Management

Deviation Management

Document Management

EHS Incident Management

Nonconformance Management

Quality Management Review

Risk Management

Supplier Quality Management

Training Management

Validation Management Solution