Data Integrity

18
Jul
Delivering your Digital Strategy Key Success Factors - Lachman Blog

Delivering your Digital Strategy: Key Success Factors

As many companies around the world look to upgrade and enhance their IT systems and digital tools, many of these upgrades and implementations have limited success unfortunately. Comprehensive training programs and change management strategies alone are not sufficient. In an era when adoption of digital technologies is key to future competitiveness and company success, the […]

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11
Jun
Interesting Facts from Fiscal Year 2023 Report on the State of Pharmaceutical Quality - Lachman Blog

Interesting Facts from Fiscal Year 2023 Report on the State of Pharmaceutical Quality

Each year, the Office of Pharmaceutical Quality (OPQ) releases a report on the state of pharmaceutical quality. This year’s report was released yesterday and can be found here. Every year we try to pick out key issues and highlight some of the statistics outlined in the report, and this year is no different! Some important […]

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26
Mar

FDA Lowers the Number of Required BA/BE Reserve Samples in Revised Guidance 

The number of reserve samples required by current regulations has been a sore subject for both NDA and ANDA sponsors as well as testing facilities as the cost and storage requirements for the required reserve samples of both test and reference product was overly burdensome.  Now, after twenty years of concern expressed by the industry, […]

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05
Feb
Helpful Tips

AAM Annual Meeting Regulatory and Science Meeting

A presentation delivered by Office of Generic Drugs Director, Iilun Murphy, M.D. during the members-only Regulatory and Policy meeting at the start of AAM’s annual meeting provided seven tips for ANDA sponsors with regard to their ANDA submissions: Submit a clear cover letter. Describe what is being submitted. State whether the submission includes a labeling […]

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08
Jan
Are Chromatograms Identified as “Incomplete Data” in Empower Really Incomplete

Are Chromatograms Identified as “Incomplete Data” in Empower Really Incomplete?

Have you ever found an Empower 3 chromatogram with no plot and the message “Incomplete Data”? You might have assumed that there was a system glitch, resulting in no data being acquired for the injection. However, data may have been acquired and can only be viewed if you have the appropriate permission(s). A search of the […]

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15
Dec

What is Your GxP Computer System Audit Trail Telling You? 

Have you reviewed your audit trail lately?  What is it telling you and your team?  We all understand the importance of audit trails, and companies review audit trails in one way or another, but does your staff truly understand what the audit trail is stating?  Processes in a GxP environment should be developed and implemented […]

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11
Dec
Manual Integration of Chromatographic Data - Lachman Consultants Blog

Manual Integration of Chromatographic Data

This blog post focuses on the unprocessed, processed, and re-processed chromatographic data (e.g., data generated using chromatographic instruments such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultra Performance Liquid Chromatography (UPLC), etc.). To some operators, the unprocessed chromatographic data might not be recognized, nor would they raise any concerns with the validity of the […]

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31
Oct

A Lachman Consultants (Ireland) Webinar – Data Governance: Integrity & Quality

Join us November 28, 2023 / 14:00 – 15:00 GMT / 9:00AM – 10:00AM EST for A Lachman Learning Experience. Data integrity is an ever-increasing concern in life sciences for the purpose of ensuring safety and enhancing quality among all manufacturers. Coming under recent scrutiny is data integrity and its far-reaching impact on manufacturing safety […]

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25
Oct
Lachman Contributes to Federal Coordination Plan to Address Drug Shortages

Lachman Contributes to Federal Coordination Plan to Address Drug Shortages

Did you ever want to do something to help half a million consumers (on average) who are impacted by a drug shortages? This may seem daunting and based on the last few years almost impossible, but the first step is clear: increase your or your company’s awareness of the situation. Knowledge is power. Lachman is […]

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