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David Ade
Published: Tuesday, May 27, 2008 - 22:00 The primary culprit is usually cost. 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 isn’t 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. 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 the Food and Drug Administration’s 21 CFR Part 11. Despite these frequently perceived deterrents there’s 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. FDA’s expectations regarding risk-based validation Justification Validation and risk assessment The FDA employs risk-assessment practices and recommends that industry should follow suit. The FDA guidance for industry Part 11, “Electronic Records; Electronic Signatures—Scope and Application” recommends that software validation be focused on “a justified and documented risk assessment and a determination of the potential of the system to affect product quality and safety, and record integrity.” Logic dictates that such documentation should include a formal risk management plan that details the risk assessment and risk mitigation activities during the implementation of the system and during installation qualification, operational qualification, and performance qualification testing phases. Risk assessment can be useful in determining system elements that are fundamental to meeting the terms outlined by the FDA in the guidelines previously discussed, such as: The next step in the risk assessment process then becomes classifying and prioritizing the identified risks using any number of risk factors. Factors often used to assess risk include: These (and any other relevant) risk classifications and priorities can then be used to help determine the need for and/or extent of validation and audit-trail implementation as well as for developing a strategy for record retention. This entire risk assessment process can be simplified and streamlined by a best-of-breed, “validation ready” software system. Realizing savings using vendor documentation A common attribute of successful and rapid risk-based validation is that the organization is able to focus more energy on PQ testing and less on IQ and OQ testing. By doing so—using only accurate, audited documentation from a vendor that has previous validation success, of course—the end result should be less validation work, faster system deployment and a reduction in overall validation costs. Quality Digest does not charge readers for its content. We believe that industry news is important for you to do your job, and Quality Digest supports businesses of all types. However, someone has to pay for this content. And that’s where advertising comes in. Most people consider ads a nuisance, but they do serve a useful function besides allowing media companies to stay afloat. They keep you aware of new products and services relevant to your industry. All ads in Quality Digest apply directly to products and services that most of our readers need. You won’t see automobile or health supplement ads. So please consider turning off your ad blocker for our site. Thanks, David Ade, a product manager at MasterControl Inc., specializes in information systems and computer validation in the pharmaceutical and software industries.Advantages to Risk-Based Validation
How to decrease computer-system validation time and costs
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?
In the “Guideline on General Principles of Process Validation,” the FDA defines validation as “Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.” In short, companies themselves may evaluate their systems and make their own determinations about how much validation testing is necessary. Taking a risk-based approach to validation as an alternative to traditional validation processes is advocated by the FDA, as long as it’s conducted thoroughly and is commensurate with the amount of risk inherent in a particular software system. The proportionate level of validation to be performed should be based on the amount of risk that can be attributed to the records generated by the system.
There are three practical motivations behind the drive toward a risk-based approach to validation:
It’s crucial to note that risk isn’t dependent in principle on the software system itself. Rather, risk is dependent on those processes the system facilitates with the records it’s managing. These specific processes that must be assessed include:
Critical risk factors
Implementing a proven and effective commercial off-the-shelf (COTS) system can save the total amount of time and money a company is required to invest in their validation efforts. The more reliant a company can be on a software vendor, the less company resources have to be devoted to validation work. It’s imperative to note, though, that companies intending to utilize vendor documentation for validation purposes must first audit the vendor’s test records prior to accepting any data. Without a thorough understanding of the vendor’s methodology and test records the company won’t be able to defend the acceptance of the vendor’s validation data. If the vendor’s data is successfully audited and can justifiably be accepted, however, it can be of great benefit in reducing the cost and time required to validate the software system.
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David Ade
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