Table 1. FDA Warnings Related to Computerized Systems
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The need to comply with regulatory requirements is a continuous process for companies under FDA oversight. The need to discover,
produce, and market safe and effective products forces the industry to comply with regulatory requirements. The use of computerized
systems and related governance processes are regulated by the Food, Drug, and Cosmetic Act,1 the Public Health Service Act,2 and other FDA regulations for overall conduct of R&D, manufacturing, and commercialization. Additionally, 21 CFR Part 11
specifically addresses the use of computerized systems in regulated industries.
Table 1. FDA Warnings Related to Computerized Systems
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This article analyzes FDA warning letters concerning computerized systems from inspections conducted in 2003 and 2004 and
discusses preventative and remediation techniques organizations can implement in preparation for agency inspections.3
Table 2. FDA Warning Letters 2003 — Compliance Issues Related to Computerized Systems
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REGULATORY FRAMEWORK
Computerized systems are instrumental in assuring the quality, safety, and integrity of FDA-regulated products. Determination
of exactly which processes and functions are under computer control enables FDA field investigators to identify those processes
most critical to drug, biologic, or medical device quality.4 It is extremely important for the agency to verify that proper controls are employed to assure the correct performance of
the computer system prior to its implementation and for the maintenance and monitoring of the system once it has been installed.5
Table 3. FDA Warning Letters 2004 — Compliance Issues Related to Computerized Systems
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In its 2003 guidance on 21 CFR Part 116, FDA suggested that an organization's decision to validate computerized systems, and the extent of the validation, should
take into account the impact that the systems have on the organization's ability to meet predicate rule requirements. An organization
should also consider the impact those systems might have on the accuracy, reliability, integrity, availability, and authenticity
of required records and signatures. Even if there is no predicate rule requirement to validate a system, in some instances
it still may be important to validate the system.7 Organizations should base their approach on a justified and documented risk assessment — a determination of the potential
of the system to affect product quality, and safety and record integrity.
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