Adam Fleming's Blog (255)

A Cyber Security Incident Response Program (CSIRP) or a Cyber Security Incident Response Team (CSIRT) that anticipates and neutralizes a cyber-incident is a critical need for organizations, because an Internet or network security breach results in loss of valuable data, as well as several resources and the organization’s reputation, and could potentially invite lawsuits.

While…

Annual registration is a requirement for any device firm, establishment or facility whose business relates to the production and distribution of medical devices intended for use in the US in some or another way.

Such business establishments have to register with the FDA and also need to list the devices that are made there and the activities that are performed on those devices.…

Verification and Validation (V & V) are two important aspects of regulatory compliance for software. What all are needed for achieving this? The FDA, GAMP and others provide guidance in the methodology and documentation needed for this. This apart; consideration of the principles in ISO 14971 can assist in providing an acceptable vehicle by which to perform and document risk-based software V&V.…

A good portion of the current recall and shipment rejection issues happen within the cold chain food transportation sector, resulting in fairly high, but preventable financial loss. This is an indication of how much scope is there to contain seepage in the food and transportation industries.

Is this happening because of lack of regulation? No. Rather, it is the lack of proper…

MS Excel is a program that has an amazing number of features that make it highly capable and suited for a number of usages. Although it has innumerable features; they come with simple shortcuts and methods. These are not always visible to the casual user. The use of these shortcuts is of tremendous use to users, because it saves them precious time, which can be put to more valuable uses. Employees who know the secrets of MS Excel are certainly likely to be more…

Although the news of a company receiving strictures from the FDA in the form of 483s, Warning Letters, and even Consent Decrees is a near daily occurrence in the industry; when it happens, it takes such companies by surprise. Not only is the company’s executive management caught off guard by these events; they are also embarrassed by the bad press they get, as well by the very expensive and damaging investigations and corrective and preventive action that follow.…

Whenever food, either in raw form or after being cooked, is transported, it carries the risk of contamination. Since the food that is being transported is so vulnerable, care has to be taken at just about every possible point in order to prevent disease from originating and spreading from the sources of food transporation. Standard procedures for washing and sanitizing the containers, in which food is transported need to be established, managed and maintained.…

The responses that organizations give to the FDA when they need to interact with it have to be very precise, technical and scientific. They are a test of the writing skills of the writer who frames these responses. The answers have to be very carefully weighed. Responses to the FDA have to be more loaded and impactful than being creative or artistic.

The power of persuasive and…

The ongoing Part 11 inspection and enforcement program is the mechanism by which the FDA continues to enforce implementation of Part 11. Using this method, this regulatory agency has, in just the last four years, issued more than 30 Warning Letters for deviations from Part 11. The most important reasons for which citations get issued by the FDA relate to insufficient integrity, security and availability of electronic records, as well as validation of software and computer…

The fact that between five and eight percent of current recall and shipment rejection issues happen within the cold chain food transportation sector, resulting in fairly high, but preventable financial loss is an indication of how much scope is there to contain seepage in the food and transportation industries.

Is this happening because of lack of regulation? No. Rather, it is…

A Cyber Security Incident Response Program (CSIRP) or a Cyber Security Incident Response Team (CSIRT) that anticipates and neutralizes a cyber-incident is a critical need for organizations, because an Internet or network security breach results in loss of valuable data, as well as several resources and the organization’s reputation and could potentially invite lawsuits.

While putting a CSIRP in place; the management has to take into consideration…