System, method, and computer-readable medium for collection of environmental data and generation of user report for compliance with FDA requirements
First Claim
1. A data management system having a universal hub in electronic communication with at least one piece of equipment used to automatically measure environmental data, the system configured to collect and store the environmental data, and generate a user report of the environmental data, the equipment selected from the group consisting of a particle counter, organism identification system, viable air sampler, rapid organism enumeration technology device, bioluminescence device, and water quality detector, the user report providing document compliance with U.S. Food and Drug Administration requirements.
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Accused Products
Abstract
A system, method, and computer-readable medium for the collecting and storing of environmental data, and generating a user report of the environmental data, the user report providing document compliance with U.S. Food and Drug Administration requirements. The collected and stored environmental data includes a wide variety of manufacturing facility parameter data, including but is not limited to, the presence of viable microbiological organisms, the presence of particulates and other environmental conditions within the facility, such as humidity, pressure, temperature, water quality (e.g., pH, conductivity, total organic content (TOC), endotoxin, coliform, and metals), and the respective amounts of different materials involved in the manufacture of the end product(s).
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Citations
31 Claims
- 1. A data management system having a universal hub in electronic communication with at least one piece of equipment used to automatically measure environmental data, the system configured to collect and store the environmental data, and generate a user report of the environmental data, the equipment selected from the group consisting of a particle counter, organism identification system, viable air sampler, rapid organism enumeration technology device, bioluminescence device, and water quality detector, the user report providing document compliance with U.S. Food and Drug Administration requirements.
- 9. A data management system having a universal hub, the universal hub interfacing with at least one add-on software module for specialized tracking of data unique for a particular manufacturing facility, the data selected from the group consisting of media growth promotion, sterility testing, media fills, bioburden, equipment maintenance and calibration, annual report, antibiotic assay, biological indicator, corrective and preventative action, cleaning and disinfection validation and tracking, container closure integrity, endotoxin testing, filter integrity, package integrity, preservative effectiveness testing, and smoke studies, the system configured to collect and store the data, and generate a user report of the data, the user report providing document compliance with U.S. Food and Drug Administration requirements.
- 14. A data management system having a universal hub in electronic communication with at least one piece of equipment used to automatically measure a first set of data, the system configured to collect and store the first set of data, and generate a first user report of the first set of data, the equipment selected from the group consisting of a particle counter, organism identification system, viable air sampler, rapid organism enumeration technology device, bioluminescence device, and water quality detector, the universal hub interfacing with at least one add-on software module for specialized tracking of a second set of data, the second set of data unique for a particular manufacturing facility, the second set of data selected from the group consisting of media growth promotion, sterility testing, media fills, bioburden, equipment maintenance and calibration, annual report, antibiotic assay, biological indicator, corrective and preventative action, cleaning and disinfection validation and tracking, container closure integrity, endotoxin testing, filter integrity, package integrity, preservative effectiveness testing, and smoke studies, the system configured to collect and store the second set of data, and generate a second user report of the second set of data, the first and second user reports providing document compliance with U.S. Food and Drug Administration requirements.
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22. A computer-readable medium having computer-executable instructions for performing the steps of:
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a) collecting environmental data from a piece of equipment used to automatically measure environmental data, the equipment selected from the group consisting of a particle counter, organism identification system, viable air sampler, rapid organism enumeration technology device, bioluminescence device, and water quality detector;
b) storing the collected environmental data; and
c) generating a user report of the environmental data, the user report providing document compliance with U.S. Food and Drug Administration requirements. - View Dependent Claims (23, 24, 25, 26)
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27. A computer-readable medium having at least one computer-executable module for specialized tracking of data unique for a particular manufacturing facility, the data selected from the group consisting of media growth promotion, sterility testing, media fills, bioburden, equipment maintenance and calibration, annual report, antibiotic assay, biological indicator, corrective and preventative action, cleaning and disinfection validation and tracking, container closure integrity, endotoxin testing, filter integrity, package integrity, preservative effectiveness testing, and smoke studies, the module having computer-executable instructions for performing the steps of
a) collecting the data; -
b) storing the collected data; and
c) generating a user report of the environmental data, the user report providing document compliance with U.S. Food and Drug Administration requirements. - View Dependent Claims (28, 29, 30, 31)
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Specification