GxP

A Fortune 500 Life Sciences Enterprise Chooses Arkivum to Provide Long Term Management of Its GxP Regulated Research Data

Retrieved on: 
Tuesday, July 16, 2019
Science, Biotechnology, Research, Health, Data management, Technology, Computing, Digital technology, Data management, Data, Transaction processing, Information technology management, GxP, Data preservation

A Fortune 500 Life Sciences enterprise chooses Arkivum to provide long term management of its regulated research data generated by its FDA Class III medical devices.

Key Points: 
  • A Fortune 500 Life Sciences enterprise chooses Arkivum to provide long term management of its regulated research data generated by its FDA Class III medical devices.
  • Arkivum will provide a long-term data management service and solution for the organisation to manage its GxP regulated research data in a compliant and scalable manner, ensuring digital data preservation, future access and usability of its data for years to come.
  • Arkivum will play a pivotal role as the enterprise is transforming their data strategy and data management workflows to remove silos generated as a result of acquisitions to build a sustainable, centralised long-term data management strategy.
  • George Waidell, VP of Life Sciences at Arkivum adds, Arkivum will provide our customer with complete confidence their research data will be accessible and usable for as long as they need it.

FDAnews Announces -- Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections Webinar, July 23, 2019

Retrieved on: 
Tuesday, July 9, 2019
GxP, GMP, Retrieval

Poor communication with the vendors that generate the data.

Key Points: 
  • Poor communication with the vendors that generate the data.
  • Yes, data retrieval is in a sorry state at far too many drug, device, biologics and diagnostics companies.
  • FDAnews has invited leading GXP (GCP/GLP/GMP) consultant, David Chesney, to help attendees get control of the data.
  • Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
    to learn about our special multisite discount.

One Day Course: Data Integrity and Document Management for GxP Compliance (London, United Kingdom - September 27, 2019) - ResearchAndMarkets.com

Retrieved on: 
Wednesday, June 5, 2019
Technology, Data management, Security, Quality, Business, Data integrity, Data quality, Transaction processing, Information technology management, Data governance, GxP, Inspection, Validation

The "Data Integrity and Document Management for GxP Compliance" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Data Integrity and Document Management for GxP Compliance" conference has been added to ResearchAndMarkets.com's offering.
  • This course will equip you with knowledge necessary to identify and avoid potential Data Integrity issues before auditors do.
  • Data integrity is now a focus for regulatory inspections, with both EU and FDA inspectors increasingly observing violations during GxP inspections.
  • You will gain an understanding of the requirements for ensuring data integrity, review data integrity inspection findings, and get practical advice on defining and implementing an appropriate data governance process for compliance with data integrity requirements.

ISPE Releases ISPE GAMP® RDI Good Practice Guide: Data Integrity

Retrieved on: 
Wednesday, June 5, 2019
Pharmaceutical industry, Good practice, Articles, Health, Good automated manufacturing practice, Gamp, GxP, Data integrity, Pharmacy, Integrity

NORTH BETHESDA, Md., June 5, 2019 /PRNewswire-PRWeb/ --The International Society for Pharmaceutical Engineering (ISPE) announced the release of their latest guide, ISPE GAMP RDI Good Practice Guide: Data Integrity Manufacturing Records .

Key Points: 
  • NORTH BETHESDA, Md., June 5, 2019 /PRNewswire-PRWeb/ --The International Society for Pharmaceutical Engineering (ISPE) announced the release of their latest guide, ISPE GAMP RDI Good Practice Guide: Data Integrity Manufacturing Records .
  • This guide features the expectations and requirements for data integrity and quality management in GMP facilities.
  • Industry manufacturers can discover approaches and methods for eliminating the risk of data integrity violations.
  • From this guide, users will learn how to:
    Purchase the new ISPE GAMP RDI Good Practice Guide: Data Integrity Manufacturing Records online , available at http://www.ispe.org/Publications/Guidance-Documents , among ISPE's other detailed education resources on a variety of industry topics.

6-Hour Virtual Seminar on GxP/GMP and its Consequences for Quality Management, Quality Audit, Documentation, and Information Technology Systems - ResearchAndMarkets.com

Retrieved on: 
Friday, May 17, 2019
Technology, Software, Quality management, Articles, GxP, Quality management system, Business, Quality assurance, Quality, GMP, Audit, Evaluation, Validation

The "6-Hour Virtual Seminar on GxP/GMP and its Consequences for Quality Management, Quality Audit, Documentation, and Information Technology Systems" webinar has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "6-Hour Virtual Seminar on GxP/GMP and its Consequences for Quality Management, Quality Audit, Documentation, and Information Technology Systems" webinar has been added to ResearchAndMarkets.com's offering.
  • Quality management system has four main components: quality planning, quality assurance, quality control, and quality improvement.
  • In this webinar, the framework of GxP/GMP regulations, quality management system, and quality audit will be described.
  • GMP requirements for information technology and how computer systems including documentation management systems must meet GxP/GMP requirements will be reviewed.

USDM Life Sciences Presents on Building Digital Trust Through Continuous GxP Cloud Compliance at Generate 2019

Retrieved on: 
Monday, March 11, 2019
Articles, Pharmaceutical industry, Validity, Clinical data management, Clinical research, Quality, Validation, GxP, USDM, Digital transformation

SANTA BARBARA, Calif., March 11, 2019 /PRNewswire-PRWeb/ -- USDM Life Sciences and Generis have partnered to deliver a superior solution for enterprise content and information management with built in GxP compliance for the life sciences industry.

Key Points: 
  • SANTA BARBARA, Calif., March 11, 2019 /PRNewswire-PRWeb/ -- USDM Life Sciences and Generis have partnered to deliver a superior solution for enterprise content and information management with built in GxP compliance for the life sciences industry.
  • USDM Cloud Assurance delivers a transformative, comprehensive solution to Generis customers to manage GxP validation and continuous compliance for Generis' flagship product, CARA.
  • USDM is the leading expert on cloud compliance and taking life science organizations through digital transformation with thousands of projects implemented around the world.
  • USDM Life Sciences provides strategy and compliant technology solutions to regulated life sciences companies and makes it easy to accelerate transformation and innovation.

1-Day Course: Data Integrity and Document Management for GxP Compliance (London, United Kingdom - September 27, 2019) - ResearchAndMarkets.com

Retrieved on: 
Monday, January 28, 2019
Technology, Data management, Quality, Business, Data integrity, Data quality, Transaction processing, Information technology management, Data governance, Inspection, GxP, Regulatory compliance, Validation, Good laboratory practice

The "Data Integrity and Document Management for GxP Compliance" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Data Integrity and Document Management for GxP Compliance" conference has been added to ResearchAndMarkets.com's offering.
  • Data integrity is now a focus for regulatory inspections, with both EU and FDA inspectors increasingly observing violations during GxP inspections.
  • This concise course covers the background to data integrity, why it is important and how its requirements affect both paper-based and computer-based systems.
  • You will gain an understanding of the requirements for ensuring data integrity, review data integrity inspection findings, and get practical advice on defining and implementing an appropriate data governance process for compliance with data integrity requirements.

1-Day Course: Data Integrity and Document Management for GxP Compliance (London, United Kingdom - March 11, 2019) - ResearchAndMarkets.com

Retrieved on: 
Tuesday, January 22, 2019
Technology, Data management, Security, Quality, Business, Data integrity, Data quality, Transaction processing, Information technology management, Data governance, Inspection, GxP, Regulatory compliance, Validation, Good laboratory practice

The "Data Integrity and Document Management for GxP Compliance" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Data Integrity and Document Management for GxP Compliance" conference has been added to ResearchAndMarkets.com's offering.
  • Data integrity is now a focus for regulatory inspections, with both EU and FDA inspectors increasingly observing violations during GxP inspections.
  • This concise course covers the background to data integrity, why it is important and how its requirements affect both paper-based and computer-based systems.
  • You will gain an understanding of the requirements for ensuring data integrity, review data integrity inspection findings, and get practical advice on defining and implementing an appropriate data governance process for compliance with data integrity requirements.

Letco Medical, L.L.C. Announces Exclusive Partnership with Sweetgrass GxP Group, L.L.C. to Launch Regulatory Solutions Program for Compounding Pharmacies

Retrieved on: 
Thursday, August 30, 2018
Compounding, Pharmacy, GxP

("Letco"), a leading supplier of quality compounding pharmacy products, supplies and equipment, in exclusive partnership with Sweetgrass GxP, a leader in providing regulatory services for compounding pharmacies, announces the launch of Letco's Regulatory Solutions Program.

Key Points: 
  • ("Letco"), a leading supplier of quality compounding pharmacy products, supplies and equipment, in exclusive partnership with Sweetgrass GxP, a leader in providing regulatory services for compounding pharmacies, announces the launch of Letco's Regulatory Solutions Program.
  • This program establishes a new industry benchmark for delivery of high quality regulatory services with exceptional price points.
  • Erik Tosh, Letco's VP of Professional Services, said, "Letco is excited to partner with Sweetgrass GxP, a best-in-class regulatory services firm, to bring another innovative program to the marketplace that squarely addresses the critical compliance needs of compounding pharmacies.
  • ("Letco"), a 100% employee-owned company headquartered in Wayne, PA, is the supply partner of choice for profit-conscious compounding pharmacies everywhere.

USDM Life Sciences' Manu Vohra to Present on Box GxP at BoxWorks 2018 in San Francisco

Retrieved on: 
Tuesday, August 28, 2018
GxP, USDM, Enterprise content management, Information technology management, Information technology, Information science

USDM Life Sciences and Box are transforming how GxP content is delivered in the heavily regulated life sciences industry.

Key Points: 
  • USDM Life Sciences and Box are transforming how GxP content is delivered in the heavily regulated life sciences industry.
  • Box provides powerful, GxP compliant, cloud content management and USDM implements Box, so it can be utilized for regulated content by life sciences organizations that must adhere to strict data regulations.
  • Manu Vohra is the Vice President of Enterprise Content Management Services and Solutions at USDM Life Sciences.
  • If you work in Life Sciences or Healthcare, partnering with USDM Life Sciences makes it easy to accelerate innovation and maximize productivity.