Adam Fleming

One of the very important activities for a laboratory is calibration. The terminology found in 21CFR160 (b) (4) spells out the requirements for this aspect of medical devices. In addition, other...

Instances of cyberattacks that lead to disruption of service, data theft or compromise and even ransomware are making the news headlines of late with alarming frequency. Cyberattacks are carried out...

The Statement on Standards for Accounting and Review Services (SSARS) is a section of the professional standards set out by The American Institute of CPA’s (AICPA), seeking to review earlier standards...

Lack of data integrity or the presence of anomalies in data is one of the primary reasons for which the FDA hauls up and penalizes an organization engaged in pharmaceutical manufacturing. As the use...

Credit card surcharge was the bone of contention in an antitrust lawsuit filed 2005. As a result, the judgment in this case, which came in mid-2012, prohibited credit card surcharge in ten States. The...

The credit card surcharge issue has always been a tricky one in the US. Back in 2005, this issue was the subject of an antitrust lawsuit, and the resultant judgment, which came in mid-2012 prohibited...

The food and beverages industry, a global one, is an interesting bag of surprising and often contradicting facts. The food and beverages industry is a really global one, meaning there is almost no...

A Component Interface (CI) helps expose a PeopleSoft component -defined as a set of pages grouped together for a business purpose -for synchronous access from another application such as PeopleCode...

Developments in the area of medical device software –i.e., the software that is put to use in medical devices –have been taking place at such a torrid pace that regulatory agencies such as the FDA...

Can human error happen in the life sciences scenario, where improvements keep happening in all its areas, ranging from processes to manufacturing to technology? Although these developments are a fact...

3rd party logistics providers (3PL), consisting of transportation, logistics, warehousing and technology is a rather packed space. Marketing and branding messages are not making the impact that is...

Some of the functions of medical device manufacturers include: Analyzing complaints Processing data Evaluating nonconformances Utilizing other quality data sources. The main purpose of this analysis...

Almost all manufacturing and development companies perform at least some verification testings or validation studies of design-outputs and/or manufacturing processes. This much is known and is simple...

Performing a water system excursion investigation and not being able to definitively conclude the root cause is one of the most frustrating experiences for a pharmaceutical company. Understandable...

The FDA’s expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions...