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In order to ensure GMP compliance, pharmaceutical laboratories have to devise a holistic and long term plan that covers all aspects of the laboratory's activities.
Good Manufacturing Practices (GMP) requirements for laboratories have been set out by various…Continue
Added by John Robinson on January 9, 2017 at 6:00am — No Comments
Software Validation Process for 21 CFR Part 11 is all about authenticity and integrity of electronic signatures and records. Care should be taken to avoid confusion and get validation right.
The FDA’s Code of Federal Regulations (CFR) is a collection of laws that regulate the various…Continue
Added by John Robinson on January 6, 2017 at 4:35am — No Comments
In July 2010, the Obama administration chalked out new Electronic Health Record Standards. These Electronic Health Record Standards were a major improvisation on the standards that…
Added by Roger Steven on January 4, 2017 at 7:00am — No Comments
A HIPAA audit is very important for service providing organizations, because the penalties for violations can bring their business down. It is important to understand the nuances of a HIPAA audit if one has to be successful.
A HIPAA audit is, for many service providing organizations, a make or break situation. This is because HIPAA audits are considered stringent. Violations can attract huge penalties, which is why getting it right the first time is extremely…Continue
Added by Roger Steven on December 9, 2016 at 4:20am — No Comments
For many professionals, writing skills are learned while they are on the job. In many cases, they would go by a preferred style or other documents or style guides that help to put a certain style in place. Editing, however, is rarely taught. Worse, the perception most people have of editing is that it is revising or rewriting a work. But the truth is different. Editing gives shape to a document. It helps to perfect and sculpt it. The big question most editors face…Continue
Added by Roger Steven on November 29, 2016 at 6:10am — No Comments
Financial institutions have long been the most important source of payments for their customers. Of late, though, with an increase in competition and the advent of new non-bank entries into the marketplace, financial institutions have come under a lot more strain than they used to be.
Financial institutions need to reinvent themselves in a number of ways. They need to adapt novel strategies to…Continue
Added by Compliance4all on November 25, 2016 at 5:03am — No Comments
Nanotechnology, a part of Quantum Physics (QP), is growing fast and has myriad uses. Nanotechnology is all about size and self-assembly. While QP deals with subatomic particles and waves; Nano relates to the atomic and molecular level. Atomic behavior and properties get dramatically changed at the Nano level. Of note are properties such as color change due to refraction of light. Gold, packaging and chemistry are some of the well-known areas into which…Continue
Added by Roger Steven on November 25, 2016 at 4:50am — No Comments
Compared to bigger actions, Recalls, 483s, Warning Letters and consent decrees are only some of the milder parts of punishments that the FDA could impose on a medical device company that fails to meet regulatory requirements. The bigger actions can include seizure, injunction, and civil money penalties. The Park Doctrine allows executives to even be sentenced to prison.
Added by Compliance4all on November 22, 2016 at 4:50am — No Comments
Food establishments continue to be a major source for pests due to the changes brought about in the means and ways by which food is produced and handled and in the ways of preparation techniques and eating habits. The pests in turn are sources for illness-causing microorganisms. The more knowledge about pest control at their disposal; the better it is for food processing and foodservice personnel, because this is essential for ensuring a safe food supply for consumers.…
Added by Compliance4all on November 17, 2016 at 4:43am — No Comments
For those in the field of exploration, there is a need to zero in on an effective and affordable methodology that identifies prospective targets which are related to, or controlled by tectonic structures. This methodology should help explorers concentrate their exploration efforts over new areas keeping their budget in control, armed even with limited or nonexistent geological information.…
Added by Compliance4all on November 16, 2016 at 4:47am — No Comments
The importance of conducting a risk analysis updating it can be gauged from the fact that failure to conduct a written risk analysis qualifies as “willful neglect”, which carries the highest Civil Money Penalty (“CMP”). This cannot be waived by the DHHS unlike violations that happen due to a reasonable cause.
Since risk analysis is a required implementation specification under the Security Rule, failure to do one amounts to willful neglect. If the civil…Continue
Added by Roger Steven on November 15, 2016 at 5:23am — No Comments
That the FDA has become more rigorous in the enforcement of Part 11 through its new Part 11 and on-going data integrity inspection and enforcement program is evident in this: In just the last three years, it issued more than 30 Warning Letters with Part 11 and data integrity violations. The most common citations are related to not only inadequate integrity, security and availability of electronic records, but also to validation of software and computer systems.…
Added by Compliance4all on November 15, 2016 at 4:44am — No Comments
The Food Safety Modernization Act (FSMA) has strengthened the FDA’s enforcement authority. The FDA now has the authority to not only mandate product recalls; the records and information they may request to see have increased as well. What has also gone up is the FDA’s documentation review authority.
Allergen mislabeling microbiological and foreign material contamination are the…
Added by Compliance4all on November 14, 2016 at 4:38am — No Comments
A common qualifying measure of physician ability is the medical specialty board certification. Because the requirements of the board are increasing; the laws that restrict such use are on the rise.
A webinar from MentorHealth, a leading provider of professional trainings for the healthcare…Continue
Added by Roger Steven on November 11, 2016 at 6:13am — No Comments
A medical device recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls are made when a) a medical device is defective; b) when it could be a risk to health, or c) when it is both defective and a risk to health.…
Added by Compliance4all on November 11, 2016 at 4:39am — No Comments
What can be and cannot be done with the use of personal devices under HIPAA is something practices and businesses that need to be compliant with the provisions of HIPAA need to be thoroughly aware of.
With changes expected in 2016 relating to personal devices as well as emailing and texting; staying…Continue
Added by Roger Steven on November 10, 2016 at 5:05am — No Comments
Our world today is unthinkable without data. We seem to be flooded by it. Day in and day out, the world processes trillions of bytes. Big Data seems to be everywhere and has compounded our already heavy reliance on data.
But has this proliferation of data made any significant difference to our lives? Has it made our business decision-making any more effective or insightful?…
Added by Compliance4all on November 10, 2016 at 4:23am — No Comments
Compliance with the Stark Law has become more than just a compliance issue. It is an Enterprise Risk Management issue, as the substantial awards and settlements in recent enforcement actions indicate. Managing their compliance and…Continue
Added by Roger Steven on November 9, 2016 at 7:27am — No Comments
Among the most important aspects that need to be taken into consideration in any application is the sample size. The sample size, when taken accurately, can be a very reliable guide to the whole. When the wrong sample size is taken for magnification, it could lead to wrong results, throwing the whole exercise into disarray. Determining the right sample size is thus of utmost importance to any application. There are scientific and verifiable means of doing this.…
Added by Compliance4all on November 9, 2016 at 4:24am — No Comments
Maintaining clean conditions in the entire food operation is essential for ensuring effective sanitation in the food industry. This can be brought about only when the residual microorganisms are destroyed after the production, storage and service areas of food establishments are cleaned thoroughly.
Ensuring a microorganism-free environment is a huge challenge for those in the food industry. This is because activities related to food, such as food production, handling,…Continue
Added by Compliance4all on November 8, 2016 at 5:01am — No Comments