Hospital Pharmacy Monitoring White Paper: 8 Ways to Ensure Data Integrity in Hospital Pharmacy Environments Of the FDA's Top 10 Observations in 503B Pharmacies, the second most common observation (69.8%) of was:"Aseptic processing areas are deficient regarding the system for monitoring environmental conditions." Reduce the risk of lost product and regulatory non-compliance in your controlled environments, pharmacies, ORs & procedure rooms, blood and tissue banks, and labs. Watch a system overview video See a Device Selection Guide View our Library of GxP Regulatory Articles The Vaisala viewLinc continuous monitoring system is ideal for Medical Temperature monitoring application and offers: Easy-to-use viewLinc software allows effortless monitoring, reporting and alarm management 24/7 remote alarming via SMS, e-mail, pager and many more to reduce the risk of lost products Custom reports that are automatically generated and delivered by email on demand Fast and easy IQOQ validation and on-site installation services for smooth start-up and higher productivity (Sample IQOQ) Low cost-of-ownership due to easy connectivity to your existing network, remote access, and scalability up to thousands of monitored locations Vaisala also offers a wide range of hand-held humidity and temperature meters for spot-checking and on-site transmitter calibrations Vaisala's H2O2 sensors are the ideal solution for environmentally safe bio-decontamination Parallel monitoring and alarming for critical medical environments, liquid nitrogen tanks, sample storage, pharmacy compounding areas "Of all the monitoring systems we looked at, the viewLinc monitoring system provided the best value ... hands down!" - Dorraine Reynolds, Pharmacy Director US-based National Research Hospital Monitoring System Features Gap-free data recording with complete audit trail. Battery-powered data loggers function up to 10 years and have large on-board memory for immunity to network failures and power outages. Remote alarming via SMS, email, flashing PC alert, and other alerting mechanisms. Fast, simple installation and validation - with our IQOQ documents or validation service. Scalable from one to thousands of monitored points. Software and devices were designed to ensure you comply with Part 11 and Annex 11 requirements. Saves on IT and installation costs by connecting easily to any standard network via Ethernet, Power over Ethernet, wireless, or Wi-Fi. Customer References Hospital Pharmacy Monitoring Related Products Vaporized Hydrogen Peroxide, Humidity and Temperature Measurement HPP270 Series The Vaisala PEROXCAP® Hydrogen Peroxide, Humidity, and Temperature Probe HPP270 series probes are designed for demanding hydrogen peroxide bio-decontamination. Read more viewLinc Continuous Monitoring System Continuous Monitoring System for Controlled Environments and GxP Applications: Monitor Temperature, Humidity & Universal Input data loggers. Read more VaiNet Wireless Temperature Data Logger RFL100 The RFL series data loggers use Vaisala’s LoRa® based VaiNet wireless technology to monitor temperature in fridges, freezers, incubators, LN2 tanks, cold rooms, and very low temperature freezers. Read more Indigo200 Series Transmitters for Vaisala smart probes Vaisala Indigo200 series transmitters are host devices for displaying measurement values from Vaisala's Smart Humidity, Temperature, Dew Point, Moisture in Oil, CO2 and H2O2 Probes. Read more Contact us Related stories Customer case Empowering patient safety and hospital accreditation through reliable measurement data How one of the largest health care providers in the U.S. leverages Vaisala humidity and temperature instruments to meet strict accreditation... Read more Customer case GMP monitoring system brings peace of mind to drug manufacturer The quality of manufactured or processed products at cleanroom facilities are protected by applicable good manufacturing practices (GMP) that... Read more Blog | Sep 5, 2023 GxP Temperature Mapping: Acceptance Criteria & Reporting In this blog, Vaisala Senior GxP Regulatory Expert Paul Daniel and validation/commissioning expert Nathan Roman answer questions on validation... Read more Blog | Aug 15, 2023 Managing GxP Monitoring System Alarms In this video blog, two validation experts answer questions on best practices for managing alarm functions for monitoring systems in GxP... Read more Blog | Jul 19, 2023 Temperature Mapping Study Design, Duration & Intervals In this video blog, two validation experts answer questions on best practices for mapping study design, including sensor placement, study... Read more Blog | Jun 23, 2023 Can you safely copy GxP data? After watching our webinar "GxP data integrity: What you don't know may make you non-compliant", we received an interesting question about... Read more Customer case Accurate environmental measurements in microbiology: Neutral Bioassay Co., Ltd. virus clearance process validation In recent years, a wide range of biological products have been used to create new drugs and therapies. However, the production processes for... Read more Blog | May 24, 2023 Intrinsically safe measurements in pharmaceutical hazardous environments Ono Pharmaceutical Co., Ltd. is one of Japan’s largest pharmaceutical companies. Their history goes back to 1717 Osaka and has been known as Ono... Read more Blog | May 15, 2023 World Metrology Day 2023: An interview with Heather Wade In this blog, Vaisala Boston Service Center Manager Alberto Benitez interviews Heather Wade, of Heather Wade Group LLC about her recent work as... Read more Blog | Mar 18, 2023 Are PDFs secure enough for GxP? This is a question that came up during our webinar on Data Integrity. In this blog, we answer at length. This is a common concern because, with... Read more Blog | Mar 8, 2023 Spot-checking measurements of environmental conditions Field spot-checking is a common way to determine the measurement accuracy of a fixed measurement instrument between calibration intervals... Read more Blog | Feb 22, 2023 How to connect the HPP270 vH2O2 probe to an Indigo500 Transmitter In this video, Vaisala Application Engineer Nevon Mansour demonstrates how to connect and configure the Vaisala HPP272 probe, which is used for... Read more Blog | Feb 4, 2023 Data Integrity & ALCOA++ principles in GxP continuous monitoring In our recent webinar “GxP data integrity: What you don't know may make you non-compliant” we received many questions. Vaisala Senior GxP... Read more Blog | Jan 26, 2023 Part 2 – Questions & answers on vH2O2 bio-decontamination in aseptic isolators In our webinar "vH2O2 Bio-decontamination: Optimizing Cycle Development in Aseptic Isolators" we received many interesting questions. In this... Read more Blog | Dec 7, 2022 Part 1 – Questions & answers on vH2O2 bio-decontamination in aseptic isolators In our webinar "vH2O2 Bio-decontamination: Optimizing Cycle Development in Aseptic Isolators" we received many interesting questions. In this... Read more Blog | Dec 2, 2022 How to time periodic audit trail reviews In our recent webinar “GxP data integrity: What you don't know may make you non-compliant” we had over 480 registrants. With so much interest in... Read more Blog | Aug 17, 2022 Part 3 – Final Q&A on controlled temperature chamber validation In this third and final video blog, Paul Daniel and Nathan Roman answer more questions, this time focusing on loaded chamber mapping with empty... Read more Blog | Jul 20, 2022 Part 2 - Q&A from our controlled temperature chamber validation webinar In this video blog, Vaisala's Paul Daniel and Nathan Roman of Genesis AEC continue to answer questions on how to validate temperature-controlled... Read more Blog | Jul 13, 2022 You asked, we answered - Another validation webinar Q&A In this blog, we present questions we didn't have time to answer during our "Ask Me Anything on Validation" webinar. If you haven't yet watched... Read more Customer case Vaisala supports the Sorbonne in environmental research on pesticides Since 2016, the Institute of Ecology and Environmental Sciences (IEES) at the Sorbonne University in Paris has been using the Vaisala Continuous... Read more Blog | Jun 21, 2022 Controlled Temperature Chamber Validation Webinar Q&A Part 1 In this first of a 3-part series of video blogs, our presenters will answer the questions on validating temperature-controlled chambers. For... Read more Blog | Jun 15, 2022 Questions & answers from our H2O2 calculator webinar If you attended our webinar on how to use our vaporized hydrogen peroxide calculator and asked a question, you’ll find the answer below… If you... Read more Blog | Apr 29, 2022 Temperature-controlled storage: Can you switch temperature set points seasonally? Vaisala Senior GxP Regulatory Expert Paul Daniel often receives questions about validation. Most questions are common to others in GxP-regulated... Read more Blog | Apr 25, 2022 A 3-part recipe for GxP monitoring system success & longevity Recently, our application engineers met with customers to plan an installation of a new viewLinc monitoring system. The customer's current... Read more Blog | Mar 23, 2022 Guest blog: Temperature mapping studies - Simplifying with validation services What is the current state of how GxP industry performs temperature mapping? Current Good Manufacturing Practice (CGMP), according to the FDA's... Read more Customer case Commissioning, Qualification & Validation: Fundamental for pharmaceutical products & life-saving therapies View PDF Operating a GxP facility that must comply with regulatory requirements is no simple matter but doing so ensures that products are... Read more Blog | Mar 5, 2022 Top US hospital ensures regulatory compliance for blood, drugs, vaccines, & nutrition In a US-based hospital recognized as one of the top 10 most innovative healthcare systems for its clinical care and groundbreaking use of... Read more Blog | Feb 23, 2022 The complex world of compounding labs The American Pharmacist’s Association (APhA) defines compounding as “the creation of a pharmaceutical preparation—a drug—by a licensed... Read more Blog | Feb 3, 2022 vH2O2 Vapor Concentration & Condensation Point This blog is the fourth in a 4-part series where we describe how process parameters influence vaporized hydrogen peroxide bio-decontamination... Read more Customer case LSNE (a PCI Pharma Company) leverages digitization to ensure quality, compliance, and data integrity Photo Source: Lyophilization Services of New England, Inc PDF Lyophilization Services of New England, Inc. (LSNE, now part of PCI Pharma... Read more Application Note - Challenges in Multi-Site GxP Monitoring In this application note, we classify the common issues in multi-site environmental monitoring systems into five broad types: Security, Administration, Geographic Variation, Multiple Site Types, and IT Infrastructure. We outline how the Vaisala viewLinc monitoring system handles these challenges in three GxP-regulated application types: warehouses, global manufacturing operations, and regional hospitals and healthcare facilities. Learn about Multisite Monitoring Articles on GxP standards & regulations Visit our repository of articles, white papers, application notes and eBooks...
Hospital Pharmacy Monitoring White Paper: 8 Ways to Ensure Data Integrity in Hospital Pharmacy Environments
Of the FDA's Top 10 Observations in 503B Pharmacies, the second most common observation (69.8%) of was:"Aseptic processing areas are deficient regarding the system for monitoring environmental conditions." Reduce the risk of lost product and regulatory non-compliance in your controlled environments, pharmacies, ORs & procedure rooms, blood and tissue banks, and labs. Watch a system overview video See a Device Selection Guide View our Library of GxP Regulatory Articles The Vaisala viewLinc continuous monitoring system is ideal for Medical Temperature monitoring application and offers: Easy-to-use viewLinc software allows effortless monitoring, reporting and alarm management 24/7 remote alarming via SMS, e-mail, pager and many more to reduce the risk of lost products Custom reports that are automatically generated and delivered by email on demand Fast and easy IQOQ validation and on-site installation services for smooth start-up and higher productivity (Sample IQOQ) Low cost-of-ownership due to easy connectivity to your existing network, remote access, and scalability up to thousands of monitored locations Vaisala also offers a wide range of hand-held humidity and temperature meters for spot-checking and on-site transmitter calibrations Vaisala's H2O2 sensors are the ideal solution for environmentally safe bio-decontamination Parallel monitoring and alarming for critical medical environments, liquid nitrogen tanks, sample storage, pharmacy compounding areas "Of all the monitoring systems we looked at, the viewLinc monitoring system provided the best value ... hands down!" - Dorraine Reynolds, Pharmacy Director US-based National Research Hospital Monitoring System Features Gap-free data recording with complete audit trail. Battery-powered data loggers function up to 10 years and have large on-board memory for immunity to network failures and power outages. Remote alarming via SMS, email, flashing PC alert, and other alerting mechanisms. Fast, simple installation and validation - with our IQOQ documents or validation service. Scalable from one to thousands of monitored points. Software and devices were designed to ensure you comply with Part 11 and Annex 11 requirements. Saves on IT and installation costs by connecting easily to any standard network via Ethernet, Power over Ethernet, wireless, or Wi-Fi. Customer References
Hospital Pharmacy Monitoring Related Products Vaporized Hydrogen Peroxide, Humidity and Temperature Measurement HPP270 Series The Vaisala PEROXCAP® Hydrogen Peroxide, Humidity, and Temperature Probe HPP270 series probes are designed for demanding hydrogen peroxide bio-decontamination. Read more viewLinc Continuous Monitoring System Continuous Monitoring System for Controlled Environments and GxP Applications: Monitor Temperature, Humidity & Universal Input data loggers. Read more VaiNet Wireless Temperature Data Logger RFL100 The RFL series data loggers use Vaisala’s LoRa® based VaiNet wireless technology to monitor temperature in fridges, freezers, incubators, LN2 tanks, cold rooms, and very low temperature freezers. Read more Indigo200 Series Transmitters for Vaisala smart probes Vaisala Indigo200 series transmitters are host devices for displaying measurement values from Vaisala's Smart Humidity, Temperature, Dew Point, Moisture in Oil, CO2 and H2O2 Probes. Read more Contact us
Vaporized Hydrogen Peroxide, Humidity and Temperature Measurement HPP270 Series The Vaisala PEROXCAP® Hydrogen Peroxide, Humidity, and Temperature Probe HPP270 series probes are designed for demanding hydrogen peroxide bio-decontamination. Read more
viewLinc Continuous Monitoring System Continuous Monitoring System for Controlled Environments and GxP Applications: Monitor Temperature, Humidity & Universal Input data loggers. Read more
VaiNet Wireless Temperature Data Logger RFL100 The RFL series data loggers use Vaisala’s LoRa® based VaiNet wireless technology to monitor temperature in fridges, freezers, incubators, LN2 tanks, cold rooms, and very low temperature freezers. Read more
Indigo200 Series Transmitters for Vaisala smart probes Vaisala Indigo200 series transmitters are host devices for displaying measurement values from Vaisala's Smart Humidity, Temperature, Dew Point, Moisture in Oil, CO2 and H2O2 Probes. Read more
Related stories Customer case Empowering patient safety and hospital accreditation through reliable measurement data How one of the largest health care providers in the U.S. leverages Vaisala humidity and temperature instruments to meet strict accreditation... Read more Customer case GMP monitoring system brings peace of mind to drug manufacturer The quality of manufactured or processed products at cleanroom facilities are protected by applicable good manufacturing practices (GMP) that... Read more Blog | Sep 5, 2023 GxP Temperature Mapping: Acceptance Criteria & Reporting In this blog, Vaisala Senior GxP Regulatory Expert Paul Daniel and validation/commissioning expert Nathan Roman answer questions on validation... Read more Blog | Aug 15, 2023 Managing GxP Monitoring System Alarms In this video blog, two validation experts answer questions on best practices for managing alarm functions for monitoring systems in GxP... Read more Blog | Jul 19, 2023 Temperature Mapping Study Design, Duration & Intervals In this video blog, two validation experts answer questions on best practices for mapping study design, including sensor placement, study... Read more Blog | Jun 23, 2023 Can you safely copy GxP data? After watching our webinar "GxP data integrity: What you don't know may make you non-compliant", we received an interesting question about... Read more Customer case Accurate environmental measurements in microbiology: Neutral Bioassay Co., Ltd. virus clearance process validation In recent years, a wide range of biological products have been used to create new drugs and therapies. However, the production processes for... Read more Blog | May 24, 2023 Intrinsically safe measurements in pharmaceutical hazardous environments Ono Pharmaceutical Co., Ltd. is one of Japan’s largest pharmaceutical companies. Their history goes back to 1717 Osaka and has been known as Ono... Read more Blog | May 15, 2023 World Metrology Day 2023: An interview with Heather Wade In this blog, Vaisala Boston Service Center Manager Alberto Benitez interviews Heather Wade, of Heather Wade Group LLC about her recent work as... Read more Blog | Mar 18, 2023 Are PDFs secure enough for GxP? This is a question that came up during our webinar on Data Integrity. In this blog, we answer at length. This is a common concern because, with... Read more Blog | Mar 8, 2023 Spot-checking measurements of environmental conditions Field spot-checking is a common way to determine the measurement accuracy of a fixed measurement instrument between calibration intervals... Read more Blog | Feb 22, 2023 How to connect the HPP270 vH2O2 probe to an Indigo500 Transmitter In this video, Vaisala Application Engineer Nevon Mansour demonstrates how to connect and configure the Vaisala HPP272 probe, which is used for... Read more Blog | Feb 4, 2023 Data Integrity & ALCOA++ principles in GxP continuous monitoring In our recent webinar “GxP data integrity: What you don't know may make you non-compliant” we received many questions. Vaisala Senior GxP... Read more Blog | Jan 26, 2023 Part 2 – Questions & answers on vH2O2 bio-decontamination in aseptic isolators In our webinar "vH2O2 Bio-decontamination: Optimizing Cycle Development in Aseptic Isolators" we received many interesting questions. In this... Read more Blog | Dec 7, 2022 Part 1 – Questions & answers on vH2O2 bio-decontamination in aseptic isolators In our webinar "vH2O2 Bio-decontamination: Optimizing Cycle Development in Aseptic Isolators" we received many interesting questions. In this... Read more Blog | Dec 2, 2022 How to time periodic audit trail reviews In our recent webinar “GxP data integrity: What you don't know may make you non-compliant” we had over 480 registrants. With so much interest in... Read more Blog | Aug 17, 2022 Part 3 – Final Q&A on controlled temperature chamber validation In this third and final video blog, Paul Daniel and Nathan Roman answer more questions, this time focusing on loaded chamber mapping with empty... Read more Blog | Jul 20, 2022 Part 2 - Q&A from our controlled temperature chamber validation webinar In this video blog, Vaisala's Paul Daniel and Nathan Roman of Genesis AEC continue to answer questions on how to validate temperature-controlled... Read more Blog | Jul 13, 2022 You asked, we answered - Another validation webinar Q&A In this blog, we present questions we didn't have time to answer during our "Ask Me Anything on Validation" webinar. If you haven't yet watched... Read more Customer case Vaisala supports the Sorbonne in environmental research on pesticides Since 2016, the Institute of Ecology and Environmental Sciences (IEES) at the Sorbonne University in Paris has been using the Vaisala Continuous... Read more Blog | Jun 21, 2022 Controlled Temperature Chamber Validation Webinar Q&A Part 1 In this first of a 3-part series of video blogs, our presenters will answer the questions on validating temperature-controlled chambers. For... Read more Blog | Jun 15, 2022 Questions & answers from our H2O2 calculator webinar If you attended our webinar on how to use our vaporized hydrogen peroxide calculator and asked a question, you’ll find the answer below… If you... Read more Blog | Apr 29, 2022 Temperature-controlled storage: Can you switch temperature set points seasonally? Vaisala Senior GxP Regulatory Expert Paul Daniel often receives questions about validation. Most questions are common to others in GxP-regulated... Read more Blog | Apr 25, 2022 A 3-part recipe for GxP monitoring system success & longevity Recently, our application engineers met with customers to plan an installation of a new viewLinc monitoring system. The customer's current... Read more Blog | Mar 23, 2022 Guest blog: Temperature mapping studies - Simplifying with validation services What is the current state of how GxP industry performs temperature mapping? Current Good Manufacturing Practice (CGMP), according to the FDA's... Read more Customer case Commissioning, Qualification & Validation: Fundamental for pharmaceutical products & life-saving therapies View PDF Operating a GxP facility that must comply with regulatory requirements is no simple matter but doing so ensures that products are... Read more Blog | Mar 5, 2022 Top US hospital ensures regulatory compliance for blood, drugs, vaccines, & nutrition In a US-based hospital recognized as one of the top 10 most innovative healthcare systems for its clinical care and groundbreaking use of... Read more Blog | Feb 23, 2022 The complex world of compounding labs The American Pharmacist’s Association (APhA) defines compounding as “the creation of a pharmaceutical preparation—a drug—by a licensed... Read more Blog | Feb 3, 2022 vH2O2 Vapor Concentration & Condensation Point This blog is the fourth in a 4-part series where we describe how process parameters influence vaporized hydrogen peroxide bio-decontamination... Read more Customer case LSNE (a PCI Pharma Company) leverages digitization to ensure quality, compliance, and data integrity Photo Source: Lyophilization Services of New England, Inc PDF Lyophilization Services of New England, Inc. (LSNE, now part of PCI Pharma... Read more
Customer case Empowering patient safety and hospital accreditation through reliable measurement data How one of the largest health care providers in the U.S. leverages Vaisala humidity and temperature instruments to meet strict accreditation... Read more
Customer case GMP monitoring system brings peace of mind to drug manufacturer The quality of manufactured or processed products at cleanroom facilities are protected by applicable good manufacturing practices (GMP) that... Read more
Blog | Sep 5, 2023 GxP Temperature Mapping: Acceptance Criteria & Reporting In this blog, Vaisala Senior GxP Regulatory Expert Paul Daniel and validation/commissioning expert Nathan Roman answer questions on validation... Read more
Blog | Aug 15, 2023 Managing GxP Monitoring System Alarms In this video blog, two validation experts answer questions on best practices for managing alarm functions for monitoring systems in GxP... Read more
Blog | Jul 19, 2023 Temperature Mapping Study Design, Duration & Intervals In this video blog, two validation experts answer questions on best practices for mapping study design, including sensor placement, study... Read more
Blog | Jun 23, 2023 Can you safely copy GxP data? After watching our webinar "GxP data integrity: What you don't know may make you non-compliant", we received an interesting question about... Read more
Customer case Accurate environmental measurements in microbiology: Neutral Bioassay Co., Ltd. virus clearance process validation In recent years, a wide range of biological products have been used to create new drugs and therapies. However, the production processes for... Read more
Blog | May 24, 2023 Intrinsically safe measurements in pharmaceutical hazardous environments Ono Pharmaceutical Co., Ltd. is one of Japan’s largest pharmaceutical companies. Their history goes back to 1717 Osaka and has been known as Ono... Read more
Blog | May 15, 2023 World Metrology Day 2023: An interview with Heather Wade In this blog, Vaisala Boston Service Center Manager Alberto Benitez interviews Heather Wade, of Heather Wade Group LLC about her recent work as... Read more
Blog | Mar 18, 2023 Are PDFs secure enough for GxP? This is a question that came up during our webinar on Data Integrity. In this blog, we answer at length. This is a common concern because, with... Read more
Blog | Mar 8, 2023 Spot-checking measurements of environmental conditions Field spot-checking is a common way to determine the measurement accuracy of a fixed measurement instrument between calibration intervals... Read more
Blog | Feb 22, 2023 How to connect the HPP270 vH2O2 probe to an Indigo500 Transmitter In this video, Vaisala Application Engineer Nevon Mansour demonstrates how to connect and configure the Vaisala HPP272 probe, which is used for... Read more
Blog | Feb 4, 2023 Data Integrity & ALCOA++ principles in GxP continuous monitoring In our recent webinar “GxP data integrity: What you don't know may make you non-compliant” we received many questions. Vaisala Senior GxP... Read more
Blog | Jan 26, 2023 Part 2 – Questions & answers on vH2O2 bio-decontamination in aseptic isolators In our webinar "vH2O2 Bio-decontamination: Optimizing Cycle Development in Aseptic Isolators" we received many interesting questions. In this... Read more
Blog | Dec 7, 2022 Part 1 – Questions & answers on vH2O2 bio-decontamination in aseptic isolators In our webinar "vH2O2 Bio-decontamination: Optimizing Cycle Development in Aseptic Isolators" we received many interesting questions. In this... Read more
Blog | Dec 2, 2022 How to time periodic audit trail reviews In our recent webinar “GxP data integrity: What you don't know may make you non-compliant” we had over 480 registrants. With so much interest in... Read more
Blog | Aug 17, 2022 Part 3 – Final Q&A on controlled temperature chamber validation In this third and final video blog, Paul Daniel and Nathan Roman answer more questions, this time focusing on loaded chamber mapping with empty... Read more
Blog | Jul 20, 2022 Part 2 - Q&A from our controlled temperature chamber validation webinar In this video blog, Vaisala's Paul Daniel and Nathan Roman of Genesis AEC continue to answer questions on how to validate temperature-controlled... Read more
Blog | Jul 13, 2022 You asked, we answered - Another validation webinar Q&A In this blog, we present questions we didn't have time to answer during our "Ask Me Anything on Validation" webinar. If you haven't yet watched... Read more
Customer case Vaisala supports the Sorbonne in environmental research on pesticides Since 2016, the Institute of Ecology and Environmental Sciences (IEES) at the Sorbonne University in Paris has been using the Vaisala Continuous... Read more
Blog | Jun 21, 2022 Controlled Temperature Chamber Validation Webinar Q&A Part 1 In this first of a 3-part series of video blogs, our presenters will answer the questions on validating temperature-controlled chambers. For... Read more
Blog | Jun 15, 2022 Questions & answers from our H2O2 calculator webinar If you attended our webinar on how to use our vaporized hydrogen peroxide calculator and asked a question, you’ll find the answer below… If you... Read more
Blog | Apr 29, 2022 Temperature-controlled storage: Can you switch temperature set points seasonally? Vaisala Senior GxP Regulatory Expert Paul Daniel often receives questions about validation. Most questions are common to others in GxP-regulated... Read more
Blog | Apr 25, 2022 A 3-part recipe for GxP monitoring system success & longevity Recently, our application engineers met with customers to plan an installation of a new viewLinc monitoring system. The customer's current... Read more
Blog | Mar 23, 2022 Guest blog: Temperature mapping studies - Simplifying with validation services What is the current state of how GxP industry performs temperature mapping? Current Good Manufacturing Practice (CGMP), according to the FDA's... Read more
Customer case Commissioning, Qualification & Validation: Fundamental for pharmaceutical products & life-saving therapies View PDF Operating a GxP facility that must comply with regulatory requirements is no simple matter but doing so ensures that products are... Read more
Blog | Mar 5, 2022 Top US hospital ensures regulatory compliance for blood, drugs, vaccines, & nutrition In a US-based hospital recognized as one of the top 10 most innovative healthcare systems for its clinical care and groundbreaking use of... Read more
Blog | Feb 23, 2022 The complex world of compounding labs The American Pharmacist’s Association (APhA) defines compounding as “the creation of a pharmaceutical preparation—a drug—by a licensed... Read more
Blog | Feb 3, 2022 vH2O2 Vapor Concentration & Condensation Point This blog is the fourth in a 4-part series where we describe how process parameters influence vaporized hydrogen peroxide bio-decontamination... Read more
Customer case LSNE (a PCI Pharma Company) leverages digitization to ensure quality, compliance, and data integrity Photo Source: Lyophilization Services of New England, Inc PDF Lyophilization Services of New England, Inc. (LSNE, now part of PCI Pharma... Read more
Application Note - Challenges in Multi-Site GxP Monitoring In this application note, we classify the common issues in multi-site environmental monitoring systems into five broad types: Security, Administration, Geographic Variation, Multiple Site Types, and IT Infrastructure. We outline how the Vaisala viewLinc monitoring system handles these challenges in three GxP-regulated application types: warehouses, global manufacturing operations, and regional hospitals and healthcare facilities. Learn about Multisite Monitoring
Articles on GxP standards & regulations Visit our repository of articles, white papers, application notes and eBooks...