DOCU Whitepapers

Enhance Product Lifecycle and Profits with a Proactive Approach

Are you taking the steps to avoid manufacturing efficiencies? Read our white paper to learn how a Design for Manufacturing approach with a contract manufacturer can help you mitigate risks while streamlining your manufacturing processes.

Sterilizing medical devices via ethylene oxide gas is an effective and common practice within the industry. EO gas is active at a relatively low temperature compared to other methods, such as steam, and it is compatible with plastics, polymers, and many products that are not compat¬ible with other sterilizati

A common problem facing many businesses is the integration of disparate systems to manage quality processes and regulatory compliance. The advent of Single Sign-On (SSO) applications and technology has allowed us to be able to more easily manage the logins to different systems, but the issue of

Change control process automation creates a consistent system to manage change requests. FDA regulated industries are held to regulatory guidance that reinforces the necessity of implementing an effective change management system.
This white paper discusses six characteristics that combine to form a

This FDA compliance bulletin describes the designed, intended compliance of AssurX QMS Software with FDA 21 CFR Part 11 Electronic Records: Electronic Signatures from the software functionality and integration aspect.

A Class III medical device manufacturer was facing quality challenges related to growth and siloed, manual processes that, if not streamlined, could ultimately be an issue of life or death.  AssurX Quality and Compliance Management Software enabled

What are the the costly mistakes to avoid & essential steps for success when planning and implementing automation within your quality management system (QMS)?

Download this 8 page white paper + companion checklist from AssurX QMS Software to ensure your quality management system is set up fo

Learn how an international multi-plant life sciences company implemented the AssurX Quality Management and Regulatory Compliance Platform and saved more than 10,500 personnel hours per year.
Bogged down by internal manual processes, the life sciences company needed a solution to streamline Adverse Event/

This white paper includes critical information pertaining to electronic complaint handling. Included within this white paper is a matrix detailing critical steps to implement a web-based complaint handling and regulatory reporting system. Outcomes from implementing an electronic complaint handling system i

Hazards that may place consumers at risk can arise at any point during a product's life cycle. The FDA Importer Guidance includes recommendations concerning preventive controls firms can implement to mitigate these hazards. If medical device manufacturers are committed to producing safe, quality products t

FDA warning letters continue to show a heavy inspector focus on getting corrective and preventive action (CAPA) right. Recently, 85% of FDA warning letters had CAPA citations. The trend of inspectors using CAPA as a bellwether for the strength of a company's overall operations and compliance is clear. This

Odds of receiving an Inspectional Observation (483) or a subsequent FDA Warning Letter are sharply on the rise. This white paper addresses what is a 483, how is a 483 different from a FDA Warning Letter, and how you should and should not respond to a 483 or FDA Warning Letter. Also included within the white

This white paper provides an in-depth look at the growing paradigm shift from relying on overburdened in-house IT departments and moving toward leveraging a nimble OnDemand Cloud QMS solution. As part of a heavily regulated industry, medical device m

Getting computer system validation (CSV) right is a key to complying with important regulations and running the most efficient shop possible in the medical device industry.

This white paper outlines a proven approach to achieving a compliant, well-controlled, validated, and easily maintained system.<

...the design of a medical device can require the materials and adhesive expertise of a flexible converter.

This white paper discusses the key features to consider when designing a medical grade foot control. We share our 65+ years of foot control knowledge with our users and guide them to the perfect design to compliment their equipment.

When designing a medical foot control there are many things that must be into account. Certain criteria must be followed in order to produce an interface that meets the standards set forth by the Medical world. Deciding on things such as paint type and the weight of the foot switch may seem minor, but they