What Do Software Validation Services Entail?

During the course of software engineering, testing and software project management, validation refers to the process of verifying that a software solution meets required specifications. This is a formalized process and is required within the life sciences. Software validation will ensure that your software solutions comply with requirements. Failing to do so can result in your company being issued a 483. If a computer system is used to provide information to a regulatory body (such as under FDA 21 CFR Part 11), or meet requirements for the regulatory body, the system must be validated. Continue reading

What Is An MES System?

A manufacturing execution system (MES) involves a computerized system that is used in manufacturing plants to indicate conditions on the plant floor and ways in which the conditions may be optimized to increase efficiency and production. Because an MES is a large, complex and varied application, there is no standard approach to implementing a MES system. Every system must be designed and customized to provide a specific solution to suit a company’s individual needs. Continue reading

Medical Device Labeling Guidelines

Medical device labeling guidelines have been updated by the U.S. Food and Drug Administration (FDA) with the aim of clarifying the ways in which medical devices may be labeled in order to prevent confusion for caregivers, patients and medical staff.

The FDA’s final rule has established a system for the unique identification of medical devices that is based on their use and means of distribution. As the system becomes fully implemented, device labels will carry a unique device identifier (UDI). Companies responsible for device labelling are also required to submit certain information pertaining to each device to the FDA’s Global Unique Device Identification Database (GUDID) so that the public can search for and download this information. Continue reading

Posted in UDI

What is the Prescription Drug Marketing Act

The Prescription Drug Marketing Act (PDMA) was signed into law by President Ronald Reagan on April 22, 1988. Its purpose is twofold: to ensure that medicinal products purchased by consumers are both effective and safe to use, and to protect U.S. consumers from misbranded, adulterated, counterfeit, under-active, or expired prescription drugs. Prior to the establishment of the PDMA, legislators felt that U.S. consumers were unable to buy prescription drugs with the confidence and certainty that the medications were effective and safe. This was found to be a result of three factors: Continue reading

10 Things to Know About 21 CFR Part 11 Compliance

10 Things to Know

21 CFR Part 11 is a section of Title 21 of the Code of Federal Regulations that authorizes the U.S. FDA rules and regulations related to electronic records and electronic signatures (ERES). It outlines the criteria which designate ERES to be a reliable equivalent to paper records. Here are ten important things you need to know about 21 CFR Part 11. Continue reading

AIM Healthcare Committee – UDI from a Healthcare Provider’s Perspective

AIM Healthcare Committee LogoAs promised, the AIM Healthcare Committee is in the process of understanding and developing thought around the impact and opportunity of UDI in a healthcare provider setting. Lisa Fohey CMRP PMP, Director of Supply Chain at the Children’s Hospital of Wisconsin, will be giving a presentation on the topic of the impact and the opportunity of UDI in a healthcare provider setting at the next AIM Healthcare Committee meeting, this coming Thursday January 15th 2015 at 10:00am Eastern.

Posted in AIM