Pharma IT Articles

During the past several years,many pharmaceutical companies identified a need for an electronic tracking system that would help them meet FDA GxP requirements.Most of the companies beganto seek a configurable product that could be quickly and easily implemented.The authorsdescribe a quality-management system that draws o­n a Good Automated ManufacturingPractice Special Interest Group document to help users implement Part 11requirements.

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An installment of the Focus o­n Quality column.


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Emerging high-tech solutions prepare to cater to industrial automation with promises of increased efficiencies, faster communications, and custom applications.

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Several reports have stressed the beneficial effects of communication by e-mail in the health care setting. Hospital pharmacists using e-mail have described improved communication within the department. Linking patients and health care professionals through e-mail will increase the involvement of patients in the participation, supervision and documentation of their own health care. KEY WORDS: Internet, e-mail, communication, pharmacy.

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FDA enforcement of a 1997 CGMP regulation 21 CFR Part 11 for electronic records andsignatures is imminent and anticipated to be extensive.The popular use of open architectures and commercial off-the-shelf software products for automated batch control and data management hasintroduced many challenges to compliance with this regulation. In addition, legacy systems are not exempt, and verification of data integrity compliance is expected to be retroactive.Batch SCADA systems have the proven ability to reduce costs and improve product consistency, and the industry is heavily dependent upon their continued application in the manufacturing environment. In this article, regulatory requirements are reviewed with real-world examples of assessment and compliance resolution for Batch SCADA systems. System functionality requirements are stressedwithout direct reference to product or service brand names.

FDA expands electronic data submission programs to improve regulatory operations and ensure appropriate and safe drug use.



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The demand for assays to detect and quantify specific DNA or RNA sequences is growing rapidly. Whether screening blood for pathogens, characterizing gene transcription patterns, or studying the relationship between genotype and phenotype, scientists are continually looking for ways to efficiently scale their investigations and refine their measurements. Generally, these genomic assays require carefully designed oligonucleotide primers and probes that are mixed with genomic samples to detect DNA or RNA targets. As genomic assays become more complex, hybridization software becomes hotter.

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Because perspectives of software vendors and users are different, there is no guarantee that commercial, off-the-shelf software will meet the user's requirements.

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Validation is required for computer systems to create,modify, maintain, archive, retrieve, or transmit data  intended for submission.To ensure that the quality assurance–quality control andthe information technology departments speak the same language,a system developerwill build documented evidence that a system’s functionality has been tested, performs as specified,and  generates reproducible results.


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This column explores why the user requirements specification and the validation plan are so important for the validation of spectrometry software.


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