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The FDA has created a process allowing sponsors to test their understanding of eCTD prior to submitting their actual Drug application?
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Especially for Pharmaceuticals

Is your biotech’s approach to IT more art than science? Learn some basic best practices that can cut IT costs and institutionalize your company’s knowledge base.
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Especially for Pharmaceuticals


Especially for Medical Devices

For medical device companies expanding within global markets, compliance with extensive regulations can be difficult to manage. The recently revised European Medical Device Vigilance System guidelines help medical device companies comply faster and more effectively with European directives.
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Especially for Blood / Biologics

Human tissues have been used for transplantation and reconstruction for years. But in many ways, quality systems in good tissue practice (GTP) have only recently been applied. Federal regulations exist but don’t extend into the clinical arena. Medical oversight and compliance with voluntary standards are important to enhance and continue the quality elements in hospital that use tissues for transplantation.
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Advantages to Risk-based Validation
By David Ade

For companies doing business in regulated environments, the benefits of implementing software systems are abundant. Improved product safety, higher quality, enhanced efficiency, and increased probability of maintaining regulatory compliance are just a sample of the numerous benefits computerized systems can provide. Why, then, do so many companies resist implementing software systems?

The primary culprit is usually cost stems. Most organizations understand that the cost of purchasing or creating a software system is only the beginning of the expenditure. What frightens off many companies is not necessarily the initial price tag but the additional, inevitable costs that are associated with validating the software system. If not carried out correctly, validation can sometimes cost as much or more than the price of the software itself. The time required to validate software systems and validation’s potential drain on resources are also often viewed as disincentives. Not to mention that there isn’t a “one size fits all” method of validating the multitude of software systems used by companies whose products are subject to regulatory requirements. Nor are there predicate rule requirements that pertain specifically to the interpretation of 21 CFR Part 11.

Despite these frequently perceived deterrents there is an increasing shift toward the use of software systems in regulatory environments, primarily for reasons of practicality and increased efficiency. The FDA has facilitated this shift by promoting a risk-based approach to validation.
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Essential Elements of Effective CAPA Systems

The end result objective of a corrective and preventative action (CAPA) is, quite simply, a solution to the issue from which the CAPA was generated. If it is not driving toward a solution, a CAPA is a waste of time and resources. For organizations in regulatory environments, CAPA is an overarching umbrella—all control points flow through to the CAPA system.

From the perspective of regulatory agencies like the U.S. Food and Drug Administration (FDA), CAPA is viewed as the central component that affects all control points including design controls, production and process controls, records and documents change controls, material controls, and facility and equipment controls. Since more than half of Form 483 observations and warning letters cite CAPA deficiencies, it is evident that FDA investigators are likely to look first at a company’s CAPA system during their inspections. In recent years the FDA has been promoting the adoption of closed loop CAPA systems where CAPA is the tool that drives reports and keeps management informed.

Some organizations are suffering from “death by CAPA;” their companies are being strangled because too many elements are included in their CAPA systems. In its most basic form, there are just two fundamental ingredients in a CAPA system: The first element is the experience, expertise, and wisdom of the personnel involved with conducting CAPA processes. If personnel do not have a prior track record with CAPA, this may be an area where an organization has less control over CAPA activities. The second core element of CAPA, one where more organizational control can be demonstrated, is process. The CAPA process requires critical thinking and an effective determination of the exact questions that need to be asked in order to come up with proper solutions.
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Upcoming Events

Check out conferences, trade shows, and other events for life science professionals.

Interphex / Pharma IT Expo 2008
(Mar. 26-28, 2008)

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Editorial Staff

Know the difference between IDE and IND? Between a 483 and a Warning Letter? How about GMP versus GTP?
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GxP Lifeline welcomes articles that are informative, interesting, and useful to life science professionals.
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