Release Notes

By Mark Gunn

The relationship between the Development team and the Quality Assurance team is extremely important to the development project. Having a good working relationship between these two groups can make the difference between the success or failure of a project meeting its’ deadlines. One of the most important channels of communications for these two groups is the Release Notes process.

Release notes identify the module information or the functionality of what will be contained in the application version being released to the QA group for testing. Although the overall release or build has been outlined in the project plan so that QA can develop their test cases and prepare for testing ahead of time, the release notes confirm that in fact the module and planned functionality is actually being released. Many things can cause a delay in the release of a module but for the most part QA has a good idea of what major functions/modules will be released. What the release notes confirm is to what extent the modules have been developed for the release. Release notes conversely also identify what functionality was left out and why it was not delivered.

The release notes also identify the defects corrected and released in this build. This is a major part of the work flow that surrounds the defect tracking system. The release notes detail which defects have been corrected and can be tested to ensure that they have been corrected. The QA manager will assign the corrected defects to QA Analysts for retesting. The defects will then be closed or sent back to development for further corrective action.

Without good release notes the QA team has no idea what to test in each build and it is a waste of time and resources to test modules that have not changed. Proper release notes allows QA to focus their attention on areas of the application that have changed and defects that have been corrected.

Mark Gunn has 25 years experience in the Quality Assurance and FDA validation fields. If you have any questions about these topics, please email Mark at Mark@mgdservices.com

FDA Watch . . . FDA 483 Warning Letters

By Mark Gunn
MGD Services

The FDA has performed a site inspection and they have issued your company a FDA 483 letter. Knowing how to deal with these legal documents (and these are legal documents) can mean the difference between eliminating potential problems or dealing with the agency in a seemingly unending stream of documentation and problems.

The response to a FDA 483 letter is your chance to tell your side of the story to possibly the only compassionate listener before Washington becomes involved. You must make certain the appropriate response will help your case and not hurt it!

The FDA investigator performing the site inspection and considering issuing a FDA 483 will attempt to verbally elicit your response to each concern, one by one. In cases where your responses can be made with certainty, you should make them. But if you are not sure, it would be better to explain to the investigator that you will supply a written response to the FDA-483 sent directly to the FDA office.

A Warning Letter differs from a 483 in several important respects. A 483 represents the observations of the inspection team (or lone investigator, if such is the case). A Warning Letter indicates that higher level FDA officials have reviewed the inspection findings and have concluded that the findings warrant further formal notification to the inspected company that FDA believes serious violations may exist.

Even if you respond verbally to the investigator on each concern, it is crucial for you to send in a written response immediately. This assures that your response is accurately provided to all interested parties, including the investigator’s supervisor and the compliance director - all of whom have a role in the decision process.

You should be aware that a Warning Letter is a FDA regulatory action. The FDA is now setting up a case against your company to take additional legal actions if the promised and proper corrective actions are not taken in an appropriate period of time.

Once the FDA 483 is issued, the only people to read it before additional legal actions against the company are recommended are the investigator's supervisor, the director of investigations and the compliance officer. If you and the investigator have a dispute during the inspection you cannot rely on the investigator to relay your position for you. It is your responsibility to state your position, and you must make the most of this opportunity in a rapid manner.

Your main objective, once you are issued a FDA 483 Letter, is to limit the financial and legal damage to the company and to get into compliance as soon as possible. If you show continued contempt for the agency and its policies, chances are you will be forced into compliance through further legal procedures, which will bring on increased expenses, the possible loss of business and harsh adverse publicity. Instead, if you show the FDA you are complying with the agency's policies without the need for further legal action; the chances are that the agency will continue to work with you to achieve compliance. Getting to this point can be attained by knowing your rights, operations, products and when to concede. The FDA's first indication that you know how to work with the agency is in your response to the FDA 483 letter.

Remember the FDA is looking to work with you to achieve compliance; you have to use this chance to let the FDA guide you and avoid additional problems.

Mark Gunn has 25 years experience in the Quality Assurance and FDA validation fields. If you have any questions about these topics, please email Mark at Mark@mgdservices.com

In the News . . . FDA Changes it’s Mind

Associated Press
09:33 AM Jul. 11, 2005 PT

WASHINGTON -- As the Food and Drug Administration considers whether to lift a voluntary ban on selling food from cloned animals, the agency is getting some resistance from an unusual source: the dairy industry.

Trade groups for farmers and companies that use dairy products are not enthusiastic about introducing milk from cloned cows into the marketplace, fearing consumers would be leery about the products.

"There's a strong general feeling among our members that consumers are not receptive to milk from cloned cows,'' said Susan Ruland, a spokeswoman for the International Dairy Foods Association, which represents food manufacturers that use dairy products.

"This seems to be one of the things where technology seems to drop something in the lap of the food companies,'' Ruland said in a recent interview. "It's not driven by the market or any benefit to the consumer.''

A 2002 Gallup poll found that 66 percent of American consumers said that cloning animals was "morally wrong.'' A March survey by the International Food Information Council, an industry trade group, reported that 63 percent of consumers would likely not buy food from cloned animals, even if the FDA determined the products were safe.

Last month, the National Milk Producers Federation, representing dairy farmers, approved a position statement that it "does not at this time support milk from cloned cows entering the marketplace until FDA determines that milk from cloned cows is the same as milk from conventionally bred animals.''

Because cloning a cow is expensive, about $20,000, selling meat from a clone wouldn't be financially viable. The main commercial benefit would be to sell milk from the clone of a prized cow, or for breeding purposes.

The dairy groups' position is at odds with the biotechnology industry and the small number of farmers who have invested in cloning cows.

Barb Glenn, director of animal biotechnology at the Biotechnology Industry Organization, predicted that cloning will benefit both consumers and producers. "With any new technology, you'll have groups concerned about it,'' she said.

Bob Schauf, a dairy farmer from Barron, Wisconsin, about 90 miles east of Minneapolis, cloned his prize-winning Holstein about four years ago, making four copies -- one of which died because of complications while calving earlier this year.

Schauf called the ban "ridiculous. It's a phobia more than anything scientific. We need to get FDA to come along and say it's fine. They're as normal as any other animal. Common sense has to take over soon.''

Because the FDA has asked farmers not to sell products from cloned animals, Schauf feeds the milk to his family and employees. He said he has other elite cows that he'd like to clone but has held off because of the government action.
In 2003, the FDA issued a summary of its draft risk assessment, which found that food from cloned animals was probably as safe as that from non-cloned animals. But it asked farmers to refrain from selling products from cloned animals until a final determination is made.

Earlier this year, a study by the Center for Regenerative Biology at the University of Connecticut found that meat and milk from cloned animals is essentially identical to that of non-cloned animals.

Aside from the health issues are questions about animal welfare, because cloned animals die in higher numbers during pregnancy and right after birth. A National Academy of Sciences panel looking at cloning raised the issue in a 2002 report.
The Humane Society of the United States urged the FDA to keep the ban in place. In a letter June 28, Wayne Pacelle, the Humane Society's president, wrote that cloning "carries too high a cost with regard to animal suffering, yet offers little benefit to humans and animals alike.''

Greg Wiles, a dairy farmer in Hagerstown, Maryland, has made two clones from a prolific Holstein. One is healthy, but the other suffers from health problems that Wiles declined to specify.

"I have said the FDA is more than welcome to get any blood or tissue samples,'' Wiles said. "I think it needs to be looked into.''

Wiles said he often thinks about disregarding the ban and selling the milk, which he now pours down the drain. "I think the FDA has taken too long to determine if it's safe or not."

The FDA declined an interview request for this story, saying in a statement that it would be "premature to discuss our findings or to make any final determinations due to the complexity of the issue.'' It added that the agency does not have a time frame for a final decision.

One of the cutting-edge animal cloning companies, Infigen of DeForest, ceased operations last year while waiting for the FDA to issue such a decision.

At the time, Infigen blamed delays in federal grants and funding cutbacks by a partner. But the company's co-founder and president, Michael Bishop, said the FDA delay was a fatal blow.
"It's hard to find people who want to do business with you when a government agency could possibly regulate against the food products entering the food chain,'' Bishop said. He predicted that cloning will never become viable for commercial livestock.