Environmental Mapping Qualification Vaisala offers comprehensive mapping qualification solutions to help you to comply with the GDP (Good Distribution Practice) regulations such as EU GDP (2013/C 343/01) and USP 36 Chapter <1079> and the forthcoming <1083>. Environmental mapping qualifications — necessary in areas that store human and investigational medicinal products — are performed by drug manufacturers, storage facilities, wholesale distributors and other stakeholders in the GxP supply chain. See a sample of Vaisala's IQOQ protocol (PDF). Vaisala Environmental Mapping Qualification offerings include: Mapping kit: Vaisala data loggers, vLog software to collect the measurement data, and the vLog IQ/OQ protocol to validate the software according to 21 CFR Part 11 and Annex 11 Temperature & humidity mapping services to profile the critical environmental dynamics of refrigerators, freezers, cold rooms, warehouses, storage areas, distribution centers, incubators, or stability chambers. Please note: This service is currently offered in Great Britain, Europe, and Japan. Optional custom calibration points for industry-best accuracy Tightened Mapping Qualification Requirements, Heightened Regulatory Expectations Good Distribution Practices have seen increased regulatory focus in the past years. This was in large part initiated by the Canadian regulatory agency Health Canada (GUI-0069, 2011), which was the first regulatory body to mention temperature mapping. This direction was soon reiterated by regulatory bodies around the globe, including: CDSCO (Central Drugs Standard Control Organization), India CFDA (China Food and Drug Administration), China EMA (European Medicines Agency), Europe Each of these organizations has since published the new or updated guidelines and documents. The USA then updated USP Chapter <1079> “Good Distribution Practices for Drug Products”. Soon thereafter several guides emerged to offer specific instructions. For example, the International Society for Pharmaceutical Engineering’s cold chain management publication provides advice on the placement of mapping qualification sensors. The Parenteral Drug Association’s Technical Report 58 discusses how to perform risk assessments related to GDP. And the Pharmaceutical Inspection Co-operation Scheme released their own GDP guide, which aligns closely with EU GDP regulation. This was an important step towards global standardization as PIC/S currently has more than 40 participant countries. Industry Changes to the Temperature-Controlled Supply Chain Drive the Need for Guidance Meanwhile, distribution activities have evolved, and distribution chains are increasingly international. However, this has resulted in an increased risk of temperature excursions. A well-executed environmental mapping qualification is the ideal method to assess and offset the risk of excursions. But, what constitutes a well-executed mapping qualification? First, studies should always be performed before any regulated medicinal products are allowed in a cold storage area, warehouse, and temperature controlled room or chambers. Mappings should be performed under representative conditions. In practice, this means seasonal mapping studies, winter and summer. In addition, mappings should include empty and loaded conditions. Once mapping qualifications have been performed for an area or chamber, the monitoring sensors are then placed according to the locations where the most temperature fluctuation occurred - often called hot and cold spots. The Principles of Validation Lead to Objective-based Qualifications The ultimate goals of the environmental mapping qualification can be summarized like so: To demonstrate temperature (and humidity, when needed) uniformity. To identify unsuitable storage areas. To determine representative monitoring points It’s important to remember that mapping qualification studies are not restricted to fixed places. For temperature controlled vehicles in the distribution chain, the original temperature mapping qualification is performed according to the fundamentals outlined above: under representative conditions, loaded and unloaded, with areas either excluded as a storage location or monitored continuously according to the results of the study. For more information on Vaisala’s Environmental Mapping Qualification solutions, please see our brochure, or contact your local service center. Resources EU GDP (2013/C 343/01) Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use USP 36 – Chapter <1179> Good Storage and Distribution Practices for Drug Products USP 36 – Chapter <1083> Good Distribution Practices (to be released in the future) 21 CRF Part 11 Electronic Records / Electronic Signatures EU GMP Annex 11 Computerized systems GUI- 0069 Guidelines for Temperature Control of Drug Products during Storage and Transportation, 2011. CDSCO Guidelines on Good Distribution practices for biological products, 2012. CFDA The Good Supply Practice for Pharmaceutical Products, GSP (China) Order of the Ministry of Health of the People’s Republic of China No. 90, 2013. ISPE Good Practice Guide – Cold Chain Management, 2011. PDA: Technical Report 58 – Risk Management for Temperature Controlled Distribution, 2012. PIC/S guide to good distribution practice for medicinal products, 2014. Further Reading French standard, AFNOR NFx15-140 Australian Standard AS2853-1986 German Standard DIN 12880. Temperature mapping of storage areas, Technical supplement to WHO Technical Report Series, No. 961, 2011, Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products, January 2014. Qualification of temperature-controlled storage areas, Technical supplement to WHO Technical Report Series, No. 961, 2011, Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products, January 2014. Contact us Environmental Mapping Qualification Related Products Validation mapping kit Ideal for stability chambers, refrigerators, freezers, incubators, warehouses, ambient environments and other demanding studies. Read more Temperature and Humidity Data Loggers DL2000 The Vaisala DL2000 data logger uses highly calibrated temperature and humidity sensors to provide accurate and stable measurement, with an optional analog input channel for other parameters and door contacts. Read more Temperature Data Loggers DL1016/1416 Vaisala's multi-application temperature data logger monitors temperatures in up to four applications with one logger – ultra-low temperature freezers, freezer/refrigerators and incubators. 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 VaiNet Wireless Temperature & Humidity Data Logger RFL100 The RFL100 data loggers use Vaisala’s proprietary VaiNet wireless technology to monitor environments ranging from warehouses, to production areas, to cleanrooms and laboratories Read more Find your Local Vaisala Contact Related stories Blog | Sep 12, 2024 Ensuring GxP Compliance with Monitoring System Transparency How viewLinc Cloud Manages Updates In life science environments, ensuring regulatory compliance is paramount. This is particularly true for... Read more Customer case Danish pharmacies invest in hi-tech environmental monitoring system Images courtesy of Insatech The construction of a new building prompted one of Denmark’s largest pharmacy businesses to invest in Vaisala’s... Read more Press Release | Aug 28, 2024 Vaisala’s newest data logger provides secure environmental monitoring for GxP compliance The VDL200 data logger extends the Ethernet connectivity capabilities of... Read more Blog | Aug 13, 2024 Selecting the Right GAMP® 5 Software Category for Your Environmental Monitoring System Recently, our Senior Regulatory Expert, Paul Daniel, was asked by a viewLinc customer how to categorize their continuous monitoring system... Read more Blog | Jun 6, 2024 Analog Vs. Digital Transmission: Data integrity for GxP applications In the realm of data collection and integrity, questions frequently arise regarding the reliability and accuracy of temperature data loggers... Read more Blog | Apr 20, 2024 Efficient monitoring system alarm testing: A hybrid approach We often receive questions from professionals in life science on best practices for creating and managing GxP environments. In this blog we... Read more Customer case GDP compliance assured at pharma distribution facility PostNord TPL has developed an impressive warehousing and distribution facility in Sweden, designed specifically to handle medicinal products... Read more Blog | Jan 26, 2024 Updating your monitoring system: At the right time, for the right reason In this video blog, you will learn about how to update your Vaisala viewLinc Continuous Monitoring System , a reliable and compliant solution... Read more Blog | Dec 13, 2023 BMS & CMS: Simplifying validation efforts and controlling costs In a recent webinar, “How Continuous Monitoring & Building Management Systems Support Monitoring, Compliance, & Control ” we received several... Read more Blog | Dec 5, 2023 EMS, CMS, BMS: Choosing the right monitoring system in CGMP Applications In a recent webinar, “ How Continuous Monitoring & Building Management Systems Support Monitoring, Compliance, & Control ” we received several... Read more Blog | Nov 9, 2023 Monitoring Systems for Clean Rooms: Qualified, Validated, or Controlled? In a recent webinar, “ How Continuous Monitoring & Building Management Systems Support Monitoring, Compliance, & Control ” we received several... Read more Customer case Environmental monitoring helps VisionGift provide restored sight & renewed life VisionGift® is a non-profit organization dedicated to the mission of Honoring Donors by Advancing Sight for all Humankind, through eye donation... Read more Customer case New cleanrooms at NorthX Biologics prompts search for better monitoring system Photo courtesy of NorthX Biologics During preparations for the construction of two new cleanroom facilities, NorthX Biologics , a leading... 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 Customer case Cyto-Facto Inc.: Advancing cell & gene therapies, providing the promise of health In April 2023, Cyto-Facto Inc. (CF) , a spin-off of the Foundation for Biomedical Research and Innovation at Kobe, Japan, began manufacturing... 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 | 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 | Dec 7, 2022 Part 1 – Questions & answers on vH2O2 bio-decontamination in aseptic isolators In our webinar " vH 2 O 2 Bio-decontamination: Optimizing Cycle Development in Aseptic Isolators" we received many interesting questions. In... 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... Read more Customer case Science-based skincare benefits from continuous monitoring & efficient validation PDF Established in 2000, Crown Laboratories is a global company that researches, develops, and manufactures skincare products ranging from over... 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 | 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 Articles on GxP standards & regulations Visit our repository of articles, white papers, application notes and eBooks...
Vaisala offers comprehensive mapping qualification solutions to help you to comply with the GDP (Good Distribution Practice) regulations such as EU GDP (2013/C 343/01) and USP 36 Chapter <1079> and the forthcoming <1083>. Environmental mapping qualifications — necessary in areas that store human and investigational medicinal products — are performed by drug manufacturers, storage facilities, wholesale distributors and other stakeholders in the GxP supply chain. See a sample of Vaisala's IQOQ protocol (PDF). Vaisala Environmental Mapping Qualification offerings include: Mapping kit: Vaisala data loggers, vLog software to collect the measurement data, and the vLog IQ/OQ protocol to validate the software according to 21 CFR Part 11 and Annex 11 Temperature & humidity mapping services to profile the critical environmental dynamics of refrigerators, freezers, cold rooms, warehouses, storage areas, distribution centers, incubators, or stability chambers. Please note: This service is currently offered in Great Britain, Europe, and Japan. Optional custom calibration points for industry-best accuracy Tightened Mapping Qualification Requirements, Heightened Regulatory Expectations Good Distribution Practices have seen increased regulatory focus in the past years. This was in large part initiated by the Canadian regulatory agency Health Canada (GUI-0069, 2011), which was the first regulatory body to mention temperature mapping. This direction was soon reiterated by regulatory bodies around the globe, including: CDSCO (Central Drugs Standard Control Organization), India CFDA (China Food and Drug Administration), China EMA (European Medicines Agency), Europe Each of these organizations has since published the new or updated guidelines and documents. The USA then updated USP Chapter <1079> “Good Distribution Practices for Drug Products”. Soon thereafter several guides emerged to offer specific instructions. For example, the International Society for Pharmaceutical Engineering’s cold chain management publication provides advice on the placement of mapping qualification sensors. The Parenteral Drug Association’s Technical Report 58 discusses how to perform risk assessments related to GDP. And the Pharmaceutical Inspection Co-operation Scheme released their own GDP guide, which aligns closely with EU GDP regulation. This was an important step towards global standardization as PIC/S currently has more than 40 participant countries. Industry Changes to the Temperature-Controlled Supply Chain Drive the Need for Guidance Meanwhile, distribution activities have evolved, and distribution chains are increasingly international. However, this has resulted in an increased risk of temperature excursions. A well-executed environmental mapping qualification is the ideal method to assess and offset the risk of excursions. But, what constitutes a well-executed mapping qualification? First, studies should always be performed before any regulated medicinal products are allowed in a cold storage area, warehouse, and temperature controlled room or chambers. Mappings should be performed under representative conditions. In practice, this means seasonal mapping studies, winter and summer. In addition, mappings should include empty and loaded conditions. Once mapping qualifications have been performed for an area or chamber, the monitoring sensors are then placed according to the locations where the most temperature fluctuation occurred - often called hot and cold spots. The Principles of Validation Lead to Objective-based Qualifications The ultimate goals of the environmental mapping qualification can be summarized like so: To demonstrate temperature (and humidity, when needed) uniformity. To identify unsuitable storage areas. To determine representative monitoring points It’s important to remember that mapping qualification studies are not restricted to fixed places. For temperature controlled vehicles in the distribution chain, the original temperature mapping qualification is performed according to the fundamentals outlined above: under representative conditions, loaded and unloaded, with areas either excluded as a storage location or monitored continuously according to the results of the study. For more information on Vaisala’s Environmental Mapping Qualification solutions, please see our brochure, or contact your local service center. Resources EU GDP (2013/C 343/01) Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use USP 36 – Chapter <1179> Good Storage and Distribution Practices for Drug Products USP 36 – Chapter <1083> Good Distribution Practices (to be released in the future) 21 CRF Part 11 Electronic Records / Electronic Signatures EU GMP Annex 11 Computerized systems GUI- 0069 Guidelines for Temperature Control of Drug Products during Storage and Transportation, 2011. CDSCO Guidelines on Good Distribution practices for biological products, 2012. CFDA The Good Supply Practice for Pharmaceutical Products, GSP (China) Order of the Ministry of Health of the People’s Republic of China No. 90, 2013. ISPE Good Practice Guide – Cold Chain Management, 2011. PDA: Technical Report 58 – Risk Management for Temperature Controlled Distribution, 2012. PIC/S guide to good distribution practice for medicinal products, 2014. Further Reading French standard, AFNOR NFx15-140 Australian Standard AS2853-1986 German Standard DIN 12880. Temperature mapping of storage areas, Technical supplement to WHO Technical Report Series, No. 961, 2011, Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products, January 2014. Qualification of temperature-controlled storage areas, Technical supplement to WHO Technical Report Series, No. 961, 2011, Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products, January 2014. Contact us
Environmental Mapping Qualification Related Products Validation mapping kit Ideal for stability chambers, refrigerators, freezers, incubators, warehouses, ambient environments and other demanding studies. Read more Temperature and Humidity Data Loggers DL2000 The Vaisala DL2000 data logger uses highly calibrated temperature and humidity sensors to provide accurate and stable measurement, with an optional analog input channel for other parameters and door contacts. Read more Temperature Data Loggers DL1016/1416 Vaisala's multi-application temperature data logger monitors temperatures in up to four applications with one logger – ultra-low temperature freezers, freezer/refrigerators and incubators. 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 VaiNet Wireless Temperature & Humidity Data Logger RFL100 The RFL100 data loggers use Vaisala’s proprietary VaiNet wireless technology to monitor environments ranging from warehouses, to production areas, to cleanrooms and laboratories Read more Find your Local Vaisala Contact
Validation mapping kit Ideal for stability chambers, refrigerators, freezers, incubators, warehouses, ambient environments and other demanding studies. Read more
Temperature and Humidity Data Loggers DL2000 The Vaisala DL2000 data logger uses highly calibrated temperature and humidity sensors to provide accurate and stable measurement, with an optional analog input channel for other parameters and door contacts. Read more
Temperature Data Loggers DL1016/1416 Vaisala's multi-application temperature data logger monitors temperatures in up to four applications with one logger – ultra-low temperature freezers, freezer/refrigerators and incubators. 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
VaiNet Wireless Temperature & Humidity Data Logger RFL100 The RFL100 data loggers use Vaisala’s proprietary VaiNet wireless technology to monitor environments ranging from warehouses, to production areas, to cleanrooms and laboratories Read more
Related stories Blog | Sep 12, 2024 Ensuring GxP Compliance with Monitoring System Transparency How viewLinc Cloud Manages Updates In life science environments, ensuring regulatory compliance is paramount. This is particularly true for... Read more Customer case Danish pharmacies invest in hi-tech environmental monitoring system Images courtesy of Insatech The construction of a new building prompted one of Denmark’s largest pharmacy businesses to invest in Vaisala’s... Read more Press Release | Aug 28, 2024 Vaisala’s newest data logger provides secure environmental monitoring for GxP compliance The VDL200 data logger extends the Ethernet connectivity capabilities of... Read more Blog | Aug 13, 2024 Selecting the Right GAMP® 5 Software Category for Your Environmental Monitoring System Recently, our Senior Regulatory Expert, Paul Daniel, was asked by a viewLinc customer how to categorize their continuous monitoring system... Read more Blog | Jun 6, 2024 Analog Vs. Digital Transmission: Data integrity for GxP applications In the realm of data collection and integrity, questions frequently arise regarding the reliability and accuracy of temperature data loggers... Read more Blog | Apr 20, 2024 Efficient monitoring system alarm testing: A hybrid approach We often receive questions from professionals in life science on best practices for creating and managing GxP environments. In this blog we... Read more Customer case GDP compliance assured at pharma distribution facility PostNord TPL has developed an impressive warehousing and distribution facility in Sweden, designed specifically to handle medicinal products... Read more Blog | Jan 26, 2024 Updating your monitoring system: At the right time, for the right reason In this video blog, you will learn about how to update your Vaisala viewLinc Continuous Monitoring System , a reliable and compliant solution... Read more Blog | Dec 13, 2023 BMS & CMS: Simplifying validation efforts and controlling costs In a recent webinar, “How Continuous Monitoring & Building Management Systems Support Monitoring, Compliance, & Control ” we received several... Read more Blog | Dec 5, 2023 EMS, CMS, BMS: Choosing the right monitoring system in CGMP Applications In a recent webinar, “ How Continuous Monitoring & Building Management Systems Support Monitoring, Compliance, & Control ” we received several... Read more Blog | Nov 9, 2023 Monitoring Systems for Clean Rooms: Qualified, Validated, or Controlled? In a recent webinar, “ How Continuous Monitoring & Building Management Systems Support Monitoring, Compliance, & Control ” we received several... Read more Customer case Environmental monitoring helps VisionGift provide restored sight & renewed life VisionGift® is a non-profit organization dedicated to the mission of Honoring Donors by Advancing Sight for all Humankind, through eye donation... Read more Customer case New cleanrooms at NorthX Biologics prompts search for better monitoring system Photo courtesy of NorthX Biologics During preparations for the construction of two new cleanroom facilities, NorthX Biologics , a leading... 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 Customer case Cyto-Facto Inc.: Advancing cell & gene therapies, providing the promise of health In April 2023, Cyto-Facto Inc. (CF) , a spin-off of the Foundation for Biomedical Research and Innovation at Kobe, Japan, began manufacturing... 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 | 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 | Dec 7, 2022 Part 1 – Questions & answers on vH2O2 bio-decontamination in aseptic isolators In our webinar " vH 2 O 2 Bio-decontamination: Optimizing Cycle Development in Aseptic Isolators" we received many interesting questions. In... 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... Read more Customer case Science-based skincare benefits from continuous monitoring & efficient validation PDF Established in 2000, Crown Laboratories is a global company that researches, develops, and manufactures skincare products ranging from over... 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 | 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 | Sep 12, 2024 Ensuring GxP Compliance with Monitoring System Transparency How viewLinc Cloud Manages Updates In life science environments, ensuring regulatory compliance is paramount. This is particularly true for... Read more
Customer case Danish pharmacies invest in hi-tech environmental monitoring system Images courtesy of Insatech The construction of a new building prompted one of Denmark’s largest pharmacy businesses to invest in Vaisala’s... Read more
Press Release | Aug 28, 2024 Vaisala’s newest data logger provides secure environmental monitoring for GxP compliance The VDL200 data logger extends the Ethernet connectivity capabilities of... Read more
Blog | Aug 13, 2024 Selecting the Right GAMP® 5 Software Category for Your Environmental Monitoring System Recently, our Senior Regulatory Expert, Paul Daniel, was asked by a viewLinc customer how to categorize their continuous monitoring system... Read more
Blog | Jun 6, 2024 Analog Vs. Digital Transmission: Data integrity for GxP applications In the realm of data collection and integrity, questions frequently arise regarding the reliability and accuracy of temperature data loggers... Read more
Blog | Apr 20, 2024 Efficient monitoring system alarm testing: A hybrid approach We often receive questions from professionals in life science on best practices for creating and managing GxP environments. In this blog we... Read more
Customer case GDP compliance assured at pharma distribution facility PostNord TPL has developed an impressive warehousing and distribution facility in Sweden, designed specifically to handle medicinal products... Read more
Blog | Jan 26, 2024 Updating your monitoring system: At the right time, for the right reason In this video blog, you will learn about how to update your Vaisala viewLinc Continuous Monitoring System , a reliable and compliant solution... Read more
Blog | Dec 13, 2023 BMS & CMS: Simplifying validation efforts and controlling costs In a recent webinar, “How Continuous Monitoring & Building Management Systems Support Monitoring, Compliance, & Control ” we received several... Read more
Blog | Dec 5, 2023 EMS, CMS, BMS: Choosing the right monitoring system in CGMP Applications In a recent webinar, “ How Continuous Monitoring & Building Management Systems Support Monitoring, Compliance, & Control ” we received several... Read more
Blog | Nov 9, 2023 Monitoring Systems for Clean Rooms: Qualified, Validated, or Controlled? In a recent webinar, “ How Continuous Monitoring & Building Management Systems Support Monitoring, Compliance, & Control ” we received several... Read more
Customer case Environmental monitoring helps VisionGift provide restored sight & renewed life VisionGift® is a non-profit organization dedicated to the mission of Honoring Donors by Advancing Sight for all Humankind, through eye donation... Read more
Customer case New cleanrooms at NorthX Biologics prompts search for better monitoring system Photo courtesy of NorthX Biologics During preparations for the construction of two new cleanroom facilities, NorthX Biologics , a leading... 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
Customer case Cyto-Facto Inc.: Advancing cell & gene therapies, providing the promise of health In April 2023, Cyto-Facto Inc. (CF) , a spin-off of the Foundation for Biomedical Research and Innovation at Kobe, Japan, began manufacturing... 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 | 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 | Dec 7, 2022 Part 1 – Questions & answers on vH2O2 bio-decontamination in aseptic isolators In our webinar " vH 2 O 2 Bio-decontamination: Optimizing Cycle Development in Aseptic Isolators" we received many interesting questions. In... 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... Read more
Customer case Science-based skincare benefits from continuous monitoring & efficient validation PDF Established in 2000, Crown Laboratories is a global company that researches, develops, and manufactures skincare products ranging from over... 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 | 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
Articles on GxP standards & regulations Visit our repository of articles, white papers, application notes and eBooks...