Medical Device QMS

Inefficient document control is the greatest detriment to compliance, dealing with time-consuming, redundant tasks; trying to keep track of documents and document versions; and never knowing who’s trained on what.

Affordable document control software goes a long way in easing that burden and making success possible.

Introduce automation into your processes. A digital document control solution is not only more efficient, it also makes it easier to keep up on regulatory changes, maintain compliance while reducing costs and accelerates time to market.

Transferring to a digital system isn’t just great for your document control — it also benefits any related processes. As part of a quality management system (QMS), document control simplifies training, corrective and preventive action (CAPA), supplier management, audits and more. The same interconnectivity that improves document control also streamlines the interaction between different aspects of a QMS.

Complying with regulations and standards is more efficient with digital solutions. Manual or hybrid systems are error-prone, cause delays and introduce product quality problems that can result in harsh regulatory penalties.

Digital document management systems allow you to truly manage your documents, thereby maintaining compliance and increasing profitability.

Making sure staff stays up to date with quality process training takes a lot of effort, but it’s essential for compliance. The employee training management system takes care of all training administration tasks. This gives training coordinators more time to focus on creating effective programs that keep employees qualified for their roles.

Communicating a change across the entire organization without anything falling through the cracks is nearly impossible, yet effortless with an automated system.

Change is rarely isolated. A change in one area will affect others. On paper-based or manual processes, those areas aren’t connected. This leads to miscommunication and delays. A quality management system (QMS) that is connected to other systems ensures compliance beyond the quality department.

An automated system ensures everyone knows about a change. Document routing, tracking and approval all happen automatically. When a change is needed for compliance, a system that minimizes human error by automation is essential.

A change isn’t compliant if you can’t show it happened. A digitized system will track changes that have been made and archive older versions. This puts your organization into an audit-ready state and ensures you can maintain that state. 

Employees need to be aware of and trained on an engineering or document change. When your quality processes are all on the same platform, any change will automatically send out training to employees.

To be compliant, manufacturers need reliable engineering change management (ECM). An unavailable part, safety concern or new regulation all mandate an engineering change. To stay compliant, avoid recalls and save on costs, companies need cloud-based, automated change management.

Get the confidence that gaps in employee training don’t derail your regulatory compliance. 

Automate all training tasks, from routing and tracking to follow-up and escalation. Your compliance will never be at risk due to lack of employee training.

Employees need to be informed of training requirements. Then, they report when their training is complete. Manual tracking, follow-up and escalation processes are slow and prone to error. Training scheduling software resolves these issues by automating all training coordination tasks.

Process changes often require document updates and new training. Connecting documentation and training processes keeps employees’ procedure training up to date. This prevents the risk of staff performing their jobs based on outdated SOPs, manuals and other documents. Your training data and documents are stored and easily retrieved from one place. You are always ready for audits and inspections.