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Pharmaceutical Production Software

10 software items found

QEdge - Full Product Quality (PQR)

QEdge - Full Product Quality (PQR)

by:Sarjen Systems Pvt. Ltd.   based inAhmedabad, INDIA
Pharmaceutical companies are required to submit a full Product Quality Review (PQR) or APQR in the U.S. and PQR in Europe to government health authorities annually, detailing key aspects of the manufacturing process for each drug they produce. APQR or PQR is a mandatory requirement that used to verify the consistency and appropriateness of an existing ...
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Ontosight Integrate - Automated Engine Software for Leadership

Ontosight Integrate - Automated Engine Software for Leadership

Manufactured by:Intelligence   based inEschborn, GERMANY
Transform, clean, and aggregate under-utilized enterprise data in ready-to-analyze state to generate visual insights. Generate real-time information and overview of all functions of a pharmaceutical company, including product performance, sales performance, budget and expenses, patient activity, call center performance, CI landscape, etc. It applies proprietary ...
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ISPE - Version Pharma 4.0 - Community of Practice (CoP)

ISPE - Version Pharma 4.0 - Community of Practice (CoP)

by:LIMS Wizards, LLC   based inNewark, DELAWARE (USA)
ISPE and its members are developing the roadmap to introduce Industry 4.0, also referred to as the Smart Factory, to the pharmaceutical industry as?Pharma 4.0™. ...
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OOS Software - Out of Specification Software

OOS Software - Out of Specification Software

by:MasterControl, Inc   based inSalt Lake City, UTAH (USA)
OOS Software to Automate Out of Specification (OOS) Processes to Comply with FDA CGMPs and 21 CFR Part 211 and Part 820 Regulations. In the FDA environment, specifications are essential in maintaining quality. CGMP regulations for finished pharmaceuticals (21 CFR Parts 210-211) and medical devices (21 CFR Part 820) require strict conformance to approved specifications which can be acheived easily ...
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PAS-X MES - Manufacturing Execution System

PAS-X MES - Manufacturing Execution System

by:Körber Pharma GmbH   based inLüneburg, GERMANY
Right First Time", "Review by Exception", "Paperless Production", "Electronic Batch Recording", "Faster Time to Market", "FDA Compliance" – these are only some of the benefits of using Werum's out-of-the-box MES software product PAS-X for your pharmaceutical and biopharmaceutical ...
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Biopharm - Version BioSolve Process - Economic Analysis Software

Biopharm - Version BioSolve Process - Economic Analysis Software

by:Biopharm Services Limited   based inBucks, UNITED KINGDOM
BioSolve Process measures the impact of running and scaling your bioprocess operations – the commercial impact to the organisation, the impact to existing or new production facilities, the impact of new technologies and the impact to the ...
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Werum - Version Pharma 4.0 - Empowering Software

Werum - Version Pharma 4.0 - Empowering Software

by:Körber Pharma GmbH   based inLüneburg, GERMANY
Werum is paving the way for digitization and IoT in pharma and biotech. Systems, equipment, and personnel have become increasingly interconnected in the digital economy, offering new opportunities for the pharma and biotech industries. Whether it’s EMI, Big Data, Plug & Produce, Smart Devices or Software as a Service, there are various concepts en route to the pharma factory of the ...
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naica - Version Pro - Electronic Records and Electronic Signatures Software (for 21 CFR Part 11 Compliance)

naica - Version Pro - Electronic Records and Electronic Signatures Software (for 21 CFR Part 11 Compliance)

Manufactured by:Stilla Technologies   based inVillejuif, FRANCE
An increasing number of laboratories are using electronic records and electronic signatures for exchanging and storing data. Electronic documentation offers many benefits, including increased efficiency and productivity when storing data and easier information sharing and data mining. The Food and Drug Administration (FDA) of the United States (USA) regulates the food and drug industry of the USA ...
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MasterControl - Document Change Control Software

MasterControl - Document Change Control Software

by:MasterControl, Inc   based inSalt Lake City, UTAH (USA)
Document change control software is essential for ensuring compliance and managing change in regulated industries such as life sciences and manufacturing. By utilizing this software, companies can effectively address the complexity of change control and streamline their ...
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ComplianceWire - FDA Training Management System for Medical Device

ComplianceWire - FDA Training Management System for Medical Device

by:AWS Truepower, LLC   based inAlbany, NEW YORK (USA)
Discover how our validated, FDA CFR Part 11 compliance training management system helps you comply with evolving FDA Regulations. Keep your workforce up to date. Medical device and pharmaceutical manufacturers trying to keep up with ever-changing regulations have a tough job. Medical technology advances quickly, and with it the need for compliance systems to support patient safety. To help you ...
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