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Quality Assurance01:19

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Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
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FDA Approved Drugs: Changes to Approved Drugs01:26

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Statistical Process Control (SPC) is a method used to monitor and control quality within processes, particularly in manufacturing and service delivery, by employing statistical methods. SPC aims to distinguish between natural (common cause) variation and variation due to specific changes or events (special cause), allowing for timely improvements and sustained quality. The control chart, a pivotal tool in SPC, visually displays data over time alongside a central line of upper and lower control...
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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
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IMPROVING (SOFTWARE) PATENT QUALITY THROUGH THE ADMINISTRATIVE PROCESS.

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Area of Science:

  • Intellectual Property Law
  • Patent Examination Quality
  • Software Patents

Background:

  • Evidence suggests a need for improved patent quality, particularly within the software domain.
  • The U.S. Patent and Trademark Office (PTO) faces institutional constraints in quality improvement efforts.

Purpose of the Study:

  • To propose pragmatic and cost-effective strategies for the PTO to enhance patent quality.
  • To demonstrate that even constrained agencies can implement quality improvement measures.
  • To focus on strategies applicable to software patents.

Main Methods:

  • Analysis of legal theory and patent doctrine.
  • Examination of new data from a PTO software examination unit with strict practices.
  • Identification of strategies deployable at initial examination and post-issuance stages.

Main Results:

  • Strategies focusing on Section 112 of the patent statute can be implemented during initial examination.
  • New post-issuance procedures under the America Invents Act offer further opportunities for quality enhancement.
  • Proposed strategies are technology-neutral but expected to significantly impact software patent quality.

Conclusions:

  • The PTO can implement effective, pragmatic strategies to improve patent quality.
  • Section 112 and America Invents Act procedures provide key avenues for quality enhancement.
  • These improvements are particularly vital for the software industry.