Quality Assurance and Control

A new streamlined electronic approach for QA audits and CAPA processes
By AssurX Inc.
Case study
In this case study, AssurX Inc. provides Galderma R&D with a streamlined QA audit system that builds a master audit plan, schedules individual audits, records and reports findings, monitors post-audit actions and complies with 21 CFR Part 11 of the Food and Drug Administration.

Integrated Quality Systems Simplify CAPA Management, Mitigate Risk and ...
White paper
This white paper by Pilgrim Software points out that quality systems must encompass the majority of their company’s processes in compliance with CAPA.

Managing corrective-preventive actions in regulated industries
By MasterControl Inc.
Application note
In this application note, MasterControl Inc. describes the need to establish an effective corrective action/preventive action (CAPA) program and how MasterControl CAPA helps companies to manage the corrective action processes that are critical in maintaining compliance.

A new streamlined electronic approach for QA audits and CAPA processes
By AssurX Inc.
Case study
In this case study, AssurX Inc. provides Galderma R&D with a streamlined QA audit system that builds a master audit plan, schedules individual audits, records and reports findings, monitors post-audit actions and complies with 21 CFR Part 11 of the Food and Drug Administration.

Achieving Quality Across the Global Manufacturing Network
By Aberdeen Group
White paper
According to this white paper by Aberdeen Group Inc., best-in-class manufacturers are significantly more likely to have a global quality program and are four times more likely than average performers to empower their decision makers with web-based, integrated technologies.

Improve processes through designed experimentation
By InSite Technologies Inc.
White paper
This white paper from InSite Technologies Inc. describes how one medical device manufacturer attained significant improvement in advancing its process understanding without having to revalidate. The company did this using designed experimentation.

Temperature mapping and monitoring: Quality control tools for pharmaceutical ...
By Johnson Controls Inc.
White paper
This white paper from Johnson Controls discusses the state of storage facilities for pharma and biomedical companies and how to optimize temperature control in warehousing spaces for temperature- and humidity-sensitive products.

ORBISPHERE 3650/55 Portable Selective Gas Measurement System
By Hach Ultra
Product collateral
The ORBISPHERE 3650/3655 offers a robust portable system solution for oxygen measurement in both the dissolved and gas phases.

Rapid material verification with handheld Raman spectroscopy
By Ahura Scientific, Inc.
Product collateral
This 4-page brochure details the capabilities and applications of Ahura's TruScan instrument, a handheld Raman spectrometer that combines advanced decision-making algorithms and an integrated workflow for chemical identification at the point of inspection.

A comparison of vibrational techniques for material verification
By Ahura Scientific, Inc.
Application note
This technical note provides a brief overview of FTIR, NIR and Raman spectroscopy and addresses questions concerning validation and performance of each technique in terms of its suitability for raw material and final product identification and verification in pharmaceuticals.

Characterizing and validating handheld Raman instrument discovery library ...
By Ahura Scientific, Inc.
Application note
This application note discusses how Ahura Scientific's handheld Raman devices are able to accurately and precisely identify unknown materials.

Reduce raw material testing time with handheld Raman spectrometers
By Ahura Scientific, Inc.
White paper
This white paper looks at the differences between Raman and other spectroscopic methods, highlights Raman's strengths and limitations, and outlines reasons why using handheld Raman for raw material testing offers an attractive return on investment.

Quality Audit: A tool for continuous improvement and compliance
By MasterControl Inc.
White paper
In the FDA and ISO environments, the audit process is closely associated with quality and directly related to regulatory compliance. This MasterControl white paper discusses the challenges facing companies that rely on a paper-based or a partially electronic system, and the benefits of implementing an electronic auditing solution.<BR>

A new streamlined electronic approach for QA audits and CAPA processes
By AssurX Inc.
Case study
In this case study, AssurX Inc. provides Galderma R&D with a streamlined QA audit system that builds a master audit plan, schedules individual audits, records and reports findings, monitors post-audit actions and complies with 21 CFR Part 11 of the Food and Drug Administration.

Implementing a proactive enterprise-wide quality system
By AssurX Inc.
Case study
In this case study, AssurX Inc. provides Fischer Imaging with a quality control system that tracks nonconformances and corrective action requests and helps streamline operations and achieve FDA compliance.

The fast guide to OEE
By Vorne Industries Inc.
White paper
This white paper by Vorne Industries Inc. provides an overview of overall equipment effectiveness (OEE), which presents complex production problems more simply and intuitively.

Biosafety Testing Services
By Cardinal Health
Product collateral
Cardinal Health provides biosafety testing services the include cell bakn characterization, in=process and lot-release testing, stability, and method development.

cGMP Informatics: IT Infrastructure Design for 21st Century Pharmaceutical QC...
By VelQuest Corp.
White paper
This white paper from VelQuest Corp. outlines a three-tiered IT architecture combining an ERP platform, a LIMS system, and a GMP Electronic Notebook to improve productivity, cost and compliance for pharmaceutical manufacturers.

Surface Chemistry Improvement on 316L Stainless Steel Weld Zones with Gelled ...
By Astro Pak Corp.
White paper
In this study, the original weld surface chemistry is compared to the passivated weld surface chemistry after treatment with a gelled citric acid-based passivation agent for two (2) and four (4) hours as well as to the passivated weld surface chemistry obtained after treatment with a standard solution-based nitric acid treatment.<BR>