A Solution for Device Manufacturers

To ensure that good quality assurance practices are used for the design of medical devices and that they are consistent with quality system requirements worldwide, the FDA requires Device Manufacturers to meet the cGMP requirements by incorporating them into the Quality System Regulation, 21 CFR Part 820. Companies that employ an electronic records system are covered by 21 CFR Part 11. The management responsibility of the quality system requirements expects management to establish & implement a quality policy to ensure compliance. As a device manufacture manager you need a solution today that meets the cGMP & 21 CFR Part 11 requirements.

The PharmaReady Document & Submissions Management Suite complies with all the areas of an FDA audited environment for this sector, International quality standards & regulations, meeting the needs of varying countries and regulatory agencies.

Meeting Your Greatest Challenges

We know your ultimate goal is to provide reliable and effective product. We make these goals easier for you to achieve by providing:

A Fully Integrated Solution: Buying solutions from different vendors at different times and piecing them together yourself can cause not only frustration by your staff but, unnecessary delays in getting your products approved, and ultimately poor results. The PharmaReady Fully-Integrated Document & Submissions Management Solution Suite includes DMS, eCTD, SPL, and TRMS all designed to seamlessly work together.
A Cost Efficient Option: Becoming and remaining 21 CFR Part 11 compliant can be a costly process. The PharmaReady product is specifically designed for organizations where ease of installation, ease of use, compliance, and affordability are the primary business drivers. Additionally, PharmaReady offers the lowest total cost of ownership in the market.
A System That Works For Everyone: Without a system that is easy to access and easy to use you can wind up with a product that your staff won’t use. PharmaReady is a web-based Document Management, Training Records Management, Structured Product Labeling, and eCTD Publishing Solution Suite. By offering you full and easy access via the web you’ll be able to use PharmaReady at your office, overseas, and at any future offices you may have.

Learn more about the fully integrated, regulatory compliant PharmaReady DMS, eCTD, SPL, and TRMS solutions.

PharmaReady - Customers