Title 21 CFR Part 11

Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).

Coverage

Practically speaking, Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions. It requires that they implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data that FDA predicate rules require them to maintain. A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11.

Super Mario

Super Mario (Japanese: スーパーマリオ, Hepburn: Sūpā Mario) is a series of platform video games created by Nintendo featuring their mascot, Mario. Alternatively called the Super Mario Bros. (スーパーマリオブラザーズ, Sūpā Mario Burazāzu) series or simply the Mario (マリオ) series, it is the central series of the greater Mario franchise. At least one Super Mario game has been released for every major Nintendo video game console and handheld.

The Super Mario games follow Mario's adventures in the fictional Mushroom Kingdom, usually with Mario as the player character. He is usually joined by his brother, Luigi, and occasionally by other members of the Mario cast. As in platform video games, the player runs and jumps across platforms and atop enemies in themed levels. The games have simple plots, typically with Mario rescuing the kidnapped Princess Peach from the primary antagonist, Bowser. The first title in the series, Super Mario Bros., released for the Nintendo Entertainment System (NES) in 1985, established gameplay concepts and elements prevalent in nearly every Super Mario game since. These include a multitude of power-ups and items that give Mario special magic powers such as fireball-throwing and size-changing into giant and miniature sizes.

Call of Duty

Call of Duty is a first-person shooter video game franchise. The series began on Microsoft Windows, and later expanded to consoles and handhelds. Several spin-off games have been released. The earlier games in the series are set primarily in World War II, including Call of Duty, Call of Duty 2, and Call of Duty 3. Beginning with Call of Duty 4: Modern Warfare, which is set in modern times, the series has shifted focus away from World War II. Modern Warfare, released November 2007, was followed by World at War and Modern Warfare 2. Black Ops, released November 2010, takes place in the Cold War, while Modern Warfare 3, released November 2011, takes place in a near-future setting. Black Ops II, released November 2012, takes place mainly in the year 2025. Call of Duty: Ghosts was released in November 2013. In May 2014, Advanced Warfare was announced. On April 9, 2015, Treyarch announced Black Ops III.

The Call of Duty games are published and owned by Activision. While Infinity Ward is still a developer, Treyarch and Sledgehammer Games also develop several of the titles with the release of the studios' games alternating with each other. Some games have been developed by Gray Matter Interactive, Nokia, Exakt Entertainment, Spark Unlimited, Amaze Entertainment, n-Space, Aspyr, Rebellion Developments, Ideaworks Game Studio, and nStigate Games. The games use a variety of engines, including the id Tech 3, the Treyarch NGL, and the IW engine.

Let's Play

Let's play may refer to:

South Park

South Park is an American adult animated sitcom created by Trey Parker and Matt Stone for the Comedy Central television network. The show revolves around four boys—Stan Marsh, Kyle Broflovski, Eric Cartman, and Kenny McCormick—and their bizarre adventures in and around the titular Colorado town. Much like The Simpsons, South Park uses a very large ensemble cast of recurring characters. Intended for mature audiences, the show has become infamous for its crude language and dark, surreal humor that satirizes a wide range of topics.

Parker and Stone developed the show from two animated shorts they created in 1992 and 1995. The latter became one of the first Internet viral videos, which ultimately led to its production as a series. South Park debuted in August 1997 with great success, consistently earning the highest ratings of any basic cable program. Subsequent ratings have varied but it remains one of Comedy Central's highest rated shows, and is slated to air through at least 2019. The pilot episode was produced using cutout animation. All subsequent episodes are created with software that emulates the cutout technique. Parker and Stone perform most of the voice acting. Since 2000, each episode is typically written and produced during the week preceding its broadcast, with Parker serving as the primary writer and director. There have been a total of 267 episodes over the course of the show's 19 seasons.