Data Integrity

Lachman Consultant Services, Inc. / Blog / Data Integrity
08
Dec

A Virtual Solution: Lachman Consultants’ Webinar Details Top Strategies & Tools for Remote Auditing and FDA Inspection Preparation

By    Dec 08, 2020    Compliance Coronavirus Data Integrity Drugs Emerging Technology Facilities FDA FDA Generics Inspections Laboratories Manufacturing Medical Devices Regulatory Affairs Science & Technology

The Coronavirus pandemic has forced organizations worldwide to adjust current business goals and objectives drastically. One priority that hasn’t changed for companies regulated by the FDA is inspection preparedness and compliance. Although this process typically requires working on-site with qualified third-party experts, auditing for FDA inspection preparedness can now occur over a remote connection as […]

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22
Oct
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Understanding Risk as It Applies to Data Integrity

By    Oct 22, 2020    Compliance Data Integrity FDA

The PDA published Technical Report 84, Introducing Data Integrity Requirements into Manufacturing and Packaging Operations (here), which reaffirms that Data Integrity is not only a concern for the laboratory but for any aspect of the pharmaceutical industry where data/records are generated and handled.  There are excellent tools within the document as it applies to the […]

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14
Sep

Lachman OnCall™ GMP Teleconsulting – When you can’t wait to get going.

By    Sep 14, 2020    Biologics Biosimilars Compliance Data Integrity Regulatory Affairs Uncategorized

When you can’t wait for answers to your GMP questions, it’s time for Lachman OnCall™. Our Subject Matter Experts (SMEs) understand you need advice right away. Lachman’s SMEs have the knowledge, experience, and skills to address your most urgent scientific, technology, and compliance-related questions, such as: “We had to shut down our sterile manufacturing plant […]

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08
Jun

Data Integrity Issues Still Plague Pharmaceutical Manufacturers – Where’s the Beef?

By    Jun 08, 2020    ANDAs BLA cGMPs Compliance Data Integrity DMFs FDA NDA Regulatory Affairs

I know that I have written about this issue multiple times (here and here; also search our blog for other data integrity posts) and I guess it is a holdover from my time at FDA and living through the generic drug scandal of the late 1980s, but, come on now, folks, the FDA’s bark seems […]

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01
Jun

Data Integrity: Beyond Electronic Records

By    Jun 01, 2020    Data Integrity Laboratories Pharmaceutical industry Regulatory Affairs

Contract Pharma recently published an article written by Timothy Rhines, Ph.D., Director in the Science and Technology Practice of Lachman Consultants. He discusses how to get your data integrity house in order. Here is a brief excerpt from the article: “The global pharmaceutical industry has been grappling with the regulatory agencies’ focus on data integrity […]

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21
Feb
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Data Integrity – Management’s Responsibilities

By    Feb 21, 2020    Analytical Methods Bioanalytical Chemistry Data Integrity Laboratories Quality

Since the initial April 2016 draft published, the pharmaceutical industry has been working to toward complying with the FDA guidance on Data Integrity and Compliance With Drug CGMP (here) which was finalized in December 2018.  One passage in the introduction of the guidance has resonated with me: “Management’s involvement in and influence on these strategies […]

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18
Feb
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Out-of-Specification Investigations – Lessons Learned, or Not?

By    Feb 18, 2020    Analytical Methods Bioanalytical Bioequivalence CBER CDER Chemistry CMC Compliance Data Integrity Laboratories Manufacturing Quality

The FDA Guidance for Industry, Investigating Out‑of-Specification (OOS) Test Results for Pharmaceutical Production, was published in October 2006 (here).  The pharmaceutical industry has had about 14 years to learn how to comply to this guidance.  A quick survey of recent Form 483s and Warning Letters would indicate that there is still much to be learned […]

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08
Jan

The Role of Risk Assessment within Data Integrity

By    Jan 08, 2020    Compliance Data Integrity FDA Regulatory Affairs Science & Technology

The World Health Organization (WHO) issued a draft guidance document titled “Guideline on Data Integrity” (October 2019) and within the document there is the statement: “Quality risk management (QRM), control strategies and sound scientific principles are required to mitigate such (Data Integrity) risks” and then further it states: “application of QRM with identification of all […]

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26
Nov
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Hope at This Time of Giving Thanks

By    Nov 26, 2019    505(b)(2) Abuse deterrent Accelerated Approval Advertising Analytical Methods ANDAs Approvals Bioanalytical Bioequivalence Biologics Biosimilars BLA Brand Name Drugs Bulk Drugs List CBER CDER Chemistry Clinical CMC Combination Products Complex Generics Compliance Compounders Compounding Controlled correspondence CVM Data Integrity DEA Device Dietary Supplements Drug Pricing Drug Shortages eCTD Emerging Technology Enforcement Exclusivity FDA FDA First Generics Foods GDUFA Fees Generics Guidance Homeopathic Drugs ICH Imports International Label Changes Labeling Laboratories Manufacturing Medical Devices NDA New Drugs OGD Opioids OTC Petitions PMA Post Approval projectsnowflake Receipts Regulatory Affairs Safety Science & Technology Shortages Training Uncategorized User Fees Validation

Just look around, watch the television, read the newspaper, and what do you see?  Seems like very few reasons to be thankful.  School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth.  Climate change is threatening the future of our children, and the environmental controls […]

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