Data Integrity

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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19
Oct

Cybersecurity, Data Integrity, and the Often Neglected Business Continuity Plan

If you are responsible for data integrity for your company and you limit your thinking to Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs), you may be creating your own vulnerability. For too long, the “unloved” business continuity plan has been a paper exercise rather than a true investment in protection of a true […]

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11
Oct

Connect With the Lachman Consultants Team at the 2023 ISPE Annual Meeting

ISPE 2023 Annual Meeting Mandalay Bay Resort Las Vegas, NV October 16th – 18th, 2023 We are looking forward to seeing you at the 2023 ISPE Annual Meeting & Expo. This annual event will usher in a revitalized focus on excellence, modernization, and harmonization in pharmaceutical science and manufacturing. MEET WITH LACHMAN CONSULTANTS AT BOOTH […]

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13
Sep
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How Mature is Your Quality Management Program?

The FDA has issued a white paper on “CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development.” The paper details a program the center intends to establish whereby the goal is to promote QMM throughout the industry. Lachman recently issued a blog relating to this initiative that can be found here. […]

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