Effective document control is the heart of any quality management system (QMS). It’s an absolute necessity for regulated businesses like medical device manufacturers.
Medical device companies are leveraging new digital technologies across their operations and document control is no exception. The range of software-based systems on offer has grown rapidly.
The trick of effective document control lies in adopting a system that’s not unnecessarily complex, fragmented, or ridiculously expensive – and that streamlines all the needed quality processes.
Features to look for in medical devices document control software
Medical device companies must adhere to strict compliance requirements to meet the industry standards that ensure the safety of their devices.
Document control as part of a complete QMS is one of these requirements. The right document control software makes compliance with vital industry standards simpler and easier.
These key features ensure the document control software you choose will help your business meet the necessary requirements.
Support for integration of quality processes across departments
A cloud-based document control software system creates a secure and centralized repository for documents and processes that can be accessed by authorized users and departments from anywhere in the world without sacrificing granular access control.
Version control and change control
Version control and change control should be a priority so that all relevant users have the most recent version of a document or procedure. Without document control software, it’s easy for users to accidentally access or reference an obsolete document.
Automated workflows and approval processes
Choose document control software that offers automation of approval workflows and task notifications. This will ensure that no steps are overlooked that can lead to non-compliance. Archiving should be automated as an option.
Modularity and scalability
Not all aspects of a QMS will apply to all companies. Find a system that allows you to choose only the modules you need. The system should be scalable, so you can add modules as needed and increase your subscription at any time to cover more users.
Reporting and analytics
Find software that offers integrated analytics and reports. Reporting and auditing are usually a requirement for compliance with medical industry standards. The right software will make it much easier to retrieve this information accurately.
How document control software can simplify quality and compliance processes
Paper-based or manual document control is time-consuming and can easily lead to mistakes. Basic cloud-base storage services might provide one or two useful features, but they can’t offer the automation necessary for a stable and secure quality management system.
isoTracker’s document control software module integrates easily with the rest of our QMS software system to help medical device companies create streamlined processes that all users can easily adhere to. Using document control software will save your company time, money and frustration.
Our software ensures that all documents are:
- properly prepared, reviewed and approved
- available in the latest approved version
- only accessible by authorized users
- only changed according to a standardized process
- tracked to record all info related to changes
- stored securely online and backed up as necessary
- easy to retrieve when required.
To learn more about our document control software for medical device companies, contact us online or sign up for a free 60-day trial to try it out for yourself.
The trial gives you full access to the whole suite of QMS modules and the option to keep the data from the trial period when you sign up.
