Integrated modules are the glue that piece the system together and help to maintain compliance, even during rapid business growth. Modules like Document Control, Risk Management, Corrective Action, Complaint Handling and Audit Management work together to ensure that compliance needs are met.
Conducting audits is an important aspect in achieving continuous improvement. Preparing for an audit takes time but automated solutions help you through the process of managing and tracking your audits. This post will describe a few benefits of Audit Management Software.
The ISO 13485:2016 standard has recently been released and with it brings a change to the mindset of how quality and compliance are viewed. The revised standard also focuses on taking a more risk-based approach, making it critical for companies to incorporate risk into their processes.
When it comes to ensuring compliance with the new standard, automated software solutions can help simplify the process.
We here at the ACME Corporation take our products very seriously. So when we receive complaint letters like the one below, we take action…corrective action. The letter came to us from this fellow, a Mr. Coyote.
A Compliance Management System simplifies your day to day tasks. Whether large or small, organizations with an automated compliance system in place can achieve cost-effective enterprise-level functionality. But what exactly does this mean and how does it benefit your company?
Here’s what it means for the life science industry…
Having to conduct a recall can be one of the most trying events an organization must go through. A recall can erode consumer trust, brand integrity and company image. It can also affect the longevity of an organization. Fortunately, there are several measures that a Compliance Management System uses to manage the process of recall as quickly and efficiently as possible.
Medical device manufacturers deal with handling complaints from many different sources such as customers, patients and other healthcare professionals as part of their profession. In this particular industry, device manufacturers receive thousands of complaints each month. Of these complaints, hundreds are escalated to the quality department for investigation, with varying degrees of severity.
The Compliance Management System holds plenty of value for an organization. For starters, it allows users to save time and resources when it comes to conducting processes. It is also provides a central storage hub that holds all of a company’s data and can be easily accessed within minutes. Since there are many different types of software out there it is beneficial to look for the system that has the most to offer for the least cost.
Below are just a few of the traits that you’ll find in a leading Compliance Management System.
Two bills introduced in Congress have the potential to expedite the FDA approval process for medical devices that receive ‘breakthrough’ designation.