Data Integrity Archives - Lachman Consultant Services, Inc.

Supply Chain Resilience and the Value of Digitization and Data Themed at the 2023 ISPE Europe Annual Conference in Amsterdam

By Scott Deckebach May 15, 2023 Compliance Data Integrity Validation

Amsterdam’s iconic concentric circles of interlocking canals, its international appeal and its historical role in shaping our modern world provided the perfect backdrop for the 2023 ISPE Europe Annual Conference which, in Amsterdam fashion, served as a focus for some of the pharmaceutical industry’s most important and contemporary challenges –forces which will most certainly reshape […]

May

Digitization and Future Highlighted at the May PDA Robotics and Automation Conference in Amsterdam

By Scott Deckebach May 08, 2023 Compliance Data Integrity FDA Regulatory Affairs

The 2023 PDA Robotics and Automation Conference, which just concluded in Amsterdam, Netherlands, highlighted the significant new value and promise of advanced technologies, robotics, automation and digitization across the pharmaceutical value chain from clinical to manufacturing to distribution, and for all sectors including small and large molecule and medical device. Conference presentations and panels highlighted […]

Apr

Clinical Study Monitoring - Lachman Consultants

Q&A Document On Clinical Study Monitoring Offers Additional Information

By Bob Pollock Apr 13, 2023 ANDAs BLA Clinical Studies Data Integrity FDA Monitoring NDA

The monitoring of clinical studies is extremely important to protect the rights, welfare and safety of the study participants, and to assure the integrity of the study data submitted to the FDA and thus, ultimately the accuracy of FDA’s evaluation of submitted studies and subsequent approval decisions. If you have been following the debarment notifications […]

Dec

Data Analysis for Business and Finance Concept

Digitization and Future Highlighted at the ISPE Pharma 4.0 and Annex 1 Conference

By Scott Deckebach Dec 14, 2022 Compliance Data Integrity Digitization

The 2022 ISPE Pharma 4.0 and Annex 1 Conference, which just concluded in Vienna, Austria, highlighted the exploding value of digitization in pharmaceutical aseptic manufacturing and quality, and how digitization will play a key role in the attainment of sustainable and robust compliance for the new revision of EU GMP Annex 1 for manufacture of […]

Dec

Are your Analytical Methods Processing Settings Part of Your Analytical Lifecycle Management Program?

By Paul Mason, PhD. Dec 12, 2022 Analytical Methods Data Integrity FDA

Processing of the laboratory instrumentation output such as the processing of chromatographic raw data continues to be a focus of global health agency investigators. This is not surprising, as the investigator will be aware of the Data Integrity (DI) risks with such a manual operation, where there is the potential of selectively adjusting integration settings […]

Nov

FDA Inspections Summit: Emerging from Covid and the Future of Data Integrity

By Patrick Day Nov 21, 2022 Compliance Data Integrity FDA

The 17th Annual FDA Inspections Summit kicked off with high energy by keynote speaker Elizabeth Miller, Pharm.D., Assistant Commissioner for Medical Products and Tobacco Operations Regulatory Affairs who presented on the FDA perspective on inspections. As the entire world emerges from the pandemic, it was reported that the ORA is holding “listening sessions” to see […]

Nov

The ISPE Annual Meeting Highlights Quality’s Mandate in the Age of Digitization

By Scott Deckebach Nov 07, 2022 Compliance Data Integrity FDA Quality

This year’s ISPE Annual Meeting and Expo in Orlando highlighted a number of key topics and trends in our industry’s digitization journey. These covered everything from industry progress with manufacturing and laboratory automation and digitization to trends in new technologies like blockchain and ways to modernize quality organization and systems to be digital future ready. […]

Oct

Data Integrity Series: Episode 6

By Scott Deckebach Oct 26, 2022 Compliance Data Integrity Emerging trends Laboratories Manufacturing Medical Devices Pharma 4.0

Data integrity is not only fundamental to a company’s license to operate and to drive new stakeholder value. It’s simply smart business. Does your company have a sustainable, cost-effective global data governance program? Get the answers you need. Watch the following video and talk to Lachman Consultants. The primary purpose of this message is solely […]

Oct

Data Integrity Series: Episode 5

By Scott Deckebach Oct 18, 2022 Compliance Data Integrity Emerging trends Laboratories Manufacturing Medical Devices Pharma 4.0

A strong organizational culture is essential for maintaining the quality and integrity of your company’s data. Does your company have a data-integrity-centric culture? Get the answers you need. Watch the following video and talk to Lachman Consultants. The primary purpose of this message is solely to educate and inform. Lachman Consultants Services, Inc. assumes no […]

Sep

Know Your Systems!

By Paul Mason, PhD. Sep 28, 2022 Computer systems Data Integrity FDA Quality

It is evident from reviewing recent health agency citations that the FDA expects that firms have a deep understanding of any systems that generate data/records and that this is reflected in the firm’s lifecycle management of those systems. What does that mean, in a practical sense? Well, a component of this understanding must extend to […]

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