Compliance Services
FEATURED REPORTS
WHAT'S NEW
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Cost-effective thermal validations: How a move to wireless data loggers can ...
by Veriteq Instruments Inc.
White paper
According to this white paper by Veriteq Instruments Inc., data logger systems offer better accuracy, better sensor stability, no calbes or wire and built-in humidity capability, among other advantages.
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Demystifying multivariate analysis
by Umetrics Inc.
White paper
In this white paper, Umetrics Inc. uses practical concepts to describe how pharma companies can apply multivariate analysis (MVA) methods to improve manufacturing processes.
REPORTS BY SUBTOPIC
Understanding and implementing efficient analytical methods development and ...
By AAI Pharma Inc.
White paper
This white paper by AAI Pharma describes the development and validation process for investigational new drug, new drug and abbreviated new drug application submissions, and advances in analytical methods development and the validation process.
Demystifying multivariate analysis
By Umetrics Inc.
White paper
In this white paper, Umetrics Inc. uses practical concepts to describe how pharma companies can apply multivariate analysis (MVA) methods to improve manufacturing processes.
Detecting intracellular cytokines in activated lymphocytes
By BD Biosciences
Application note
In this application note, BD Biosciences describes the intracellular flow cytometric assay that forms the basis of its FASTImmune Cytokine System.
Small molecule separations and fast LC on 90 Å and 300 Å reversed-phase columns
By Grace Davison Discovery Sciences
Application note
In this application note, Grace Vydac, now Grace Davison Discovery Sciences, discusses the benefits of Vydac 300 Å columns for small-molecule high-pressure liquid chromatography (HPLC) applications.
Automation: An approach to the standardization of functional immune based ...
By Beckman Coulter Inc.
Application note
In this application note, Beckman Coulter Inc. compares the manual and automated immune cell assays (ICS) method. The ICS method offers the benefit of automation, which provides a greater degree of standardization in these functional assays and allows for a correlation of variability and complex immune response profiles as surrogate markers of vaccine efficacy.
Polymerase chain reaction amplification of Y chromosome
By BD Biosciences
Application note
In this application note, BD Biosciences describes polymerase chain reaction (PCR) amplification of the Y chromosome with different concentrations of Daudi cells, which are added to peripheral blood mononuclear cells (PBMCs) from female donors and sorted with FACsort.
Quantitative analysis of the cell cycle in imaging applications
By BD Biosciences
Application note
In this application note, BD Biosciences quantifies the degree to which cells are arrested in different cycle phases after drug treatment, useful in oncology and other fields where drug responses are suspected to be dependent on a specific cell cycle phase.
There are currently no reports available for this topic.
Optimizing enterprise information security compliance
By VeriSign Inc.
White paper
This white paper by VeriSign explains information-security compliance and auditing among companies that must contend not only with internal, federal and industry-specific regulations and policies, but also with security practices and requirements of their networked partners, suppliers and customers.
Compliance and mobile computing
By Intermec Technologies Corp.
White paper
This white paper by Intermec Technologies describes compliance and mobile computing concepts, including steps to secure mobile applications, best practices of mobile computing, and automatic identification and data capture (AIDC) to store securely sensitive customer data.
Speed, communication and high-quality science for biopharmaceuticals
By MDS Pharma Services
Case study
In this case study, MDS Pharma Services provides Roche Pharmaceuticals with speedy turnaround and high-quality service on lot-to-lot validation and other biosafety tests needed for a Food and Drug Administration audit.
Compliance versus competitive advantage
By Clarkston Consulting
White paper
This white paper by Clarkston Consulting describes how chief information officers can consider compliance from a strategic point of view, including addressing education, internal reviews, problem areas and audits.
Advanced standard operating procedures
By Rockwell Automation Inc.
Application note
In this application note, Rockwell Automation Inc. describes how its compliance services support and lead initiatives to help optimize, enhance or substitute standard operating procedures to optimally use risk-based concepts and to streamline SOP system for efficiency.
Compliance challenges with enterprise application integration
By Clarkston Consulting
White paper
This white paper by Clarkston Consulting describes challenges faced by life sciences companies to meet 21 CFR Part 11 regulations with respect to enterprise application integration.
Validated HPLC columns
By MAC-MOD Analytical Inc.
Application note
In this application note, MAC-MOD Analytical Inc. describes a method of validating high-performance liquid chromatography (HPLC) columns that assures constant column performance over the lifetime of an analytical method.
Executive briefing toward an approach to intellectual property
By Auto-ID Laboratories
White paper
This white paper by Auto-ID Laboratories discusses intellectual property with respect to free markets, corporate competitive advantage and rights of patent holders.
Product positioning
By MasterControl Inc.
White paper
This white paper by MasterControl Inc. describes 21 CFR Part 11 regulations regarding electronic signatures and document encryption.
Bar codes and manufacturing
By Zebra Technologies Corp.
White paper
This white paper by Zebra Technologies Corp. enters a manufacturing facility and provides an overview of the many applications of bar coding.
Cost-effective thermal validations: How a move to wireless data loggers can ...
By Veriteq Instruments Inc.
White paper
According to this white paper by Veriteq Instruments Inc., data logger systems offer better accuracy, better sensor stability, no calbes or wire and built-in humidity capability, among other advantages.
Scorecards and dashboards: More than just technology
By Clarkston Consulting
White paper
Before implementing a scorecard or dashboard application, according to this white paper from Clarkston Consulting, executives should consider what information or metrics they require to provide the right focus on organization, success and business value.
HealthCast tactics: A blueprint for the future
By PricewaterhouseCoopers
White paper
For this 2002 report by PricewaterhouseCoopers, more than 65 health care thought leaders were interviewed. The survey found significant gaps in providers reporting quality and safety data, payers reducing unnecessary administrative costs, and understanding how patient data is shared.
Industry-specific OLAP: The coming wave of data analysis
By DataLoom Solutions
White paper
DataLoom Solutions discusses the advancements in data management technology and how Industry-Specific OLAP (ISO) overcomes the limitations of datawarehousing technology.
A role for service providers in data integration and electronic data capture ...
By IDC
White paper
This white paper from IDC Corp. discusses grid computing and how pharmaceutical companies can accelerate drug discovery using massive amounts of compute power to screen molecules against targeted diseases.
Dedicated team provides significant efficiencies
By Quintiles Transnational Corp.
Case study
In this case study, Quintiles Transnational demonstrates its ability to work on a customer's data management system by dialing into their system, offering important efficiencies such as ongoing, real-time access to data and metrics.
Data Management
By AAI Pharma Inc.
Product collateral
AAI Pharma's data management systems are capable of electronic data capture, database development and programming, CRF design, data entry and validation, coding, custom reporting and data extraction, and SAE reconciliation.
Cisco Compatible Extensions (CCX) for wireless data collection as an ...
By Intermec Technologies Corp.
Product collateral
Intermec develops, manufactures, and integrates both wired and wireless automated data collection, Intellitag RFID (radio frequency identification), and mobile computing systems for companies worldwide. Its wireless data systems allow companies to identify, track, and monitor virtually anything that moves.
RFID as data capture technology
By Intermec Technologies Corp.
Product collateral
Intermec develops, manufactures, and integrates both wired and wireless automated data collection, Intellitag RFID (radio frequency identification), and mobile computing systems for companies worldwide. Its wireless data systems allow companies to identify, track, and monitor virtually anything that moves.
21 CFR Part 11 remediation strategies
By Eurotherm Inc.
White paper
This white paper by Eurotherm Inc. describes ways to achieve compliance with the requirements of 21 CFR Part 11, specifically regarding the use of electronic records, and the role of remediation.
Automating document change control
By MasterControl Inc.
White paper
This white paper by MasterControl Inc. describes the quality system lifecycle and the capabilities necessary to automate change control processes to increase efficiency and ensure Food and Drug Administration compliance.
Product positioning
By MasterControl Inc.
White paper
This white paper by MasterControl Inc. describes 21 CFR Part 11 regulations regarding electronic signatures and document encryption.
Guidance for submitting influenza resistance data
By FDA Center for Drug Evaluation and Research
White paper
This white paper by the FDA's Center for Drug Evaluation and Research (CDER) offers guidance for submitting influenza resistance data.
There are currently no reports available for this topic.
There are currently no reports available for this topic.
There are currently no reports available for this topic.
There are currently no reports available for this topic.
Environmental control in biological production rooms utilizing vaporized ...
By Steris Corp.
Case study
In this case study, Steris Corp. conducts a study to determine and compare the efficacy of vaporized hydrogen peroxide (VHP) and ultra-violet room biodecontamination applications effectiveness.
Environmental cGMP compliance
By Honeywell Process Solutions
White paper
This white paper by Honeywell describes its Enterprise Buildings Integrator (EBI) software's capabilities with respect to current Good Manufacturing Practices (cGMP) compliance.
There are currently no reports available for this topic.
There are currently no reports available for this topic.
Flow meter with 904LTM alloy stainless steel wetted parts for USP pure water ...
White paper
This white paper by Endress & Hauser Inc. investigates and compares properties of 904L stainless steel to 316L stainless steel and test protocols and results of 904L stainless steel in contact with USP purified water.
Comparison of Kvick cassettes and two competitive cassettes
By GE Healthcare Bio-Sciences
Application note
In this application note, GE Healthcare Bio-Sciences, formerly Amersham Biosciences, describes a comparison study of Kvick cassettes and two competitive cassettes for the concentration and diafiltration of human serum albumin (HSA).
There are currently no reports available for this topic.
There are currently no reports available for this topic.
There are currently no reports available for this topic.
There are currently no reports available for this topic.
There are currently no reports available for this topic.
Syringe infuser syringe comparison
By Baxa Corp.
Application note
In this application note, Baxa Corp. compares the performance of four different manufacturers’ syringes in order to rate performance in the Braun Perfusor Basic syringe infuser.
Executive briefing toward an approach to intellectual property
By Auto-ID Laboratories
White paper
This white paper by Auto-ID Laboratories discusses intellectual property with respect to free markets, corporate competitive advantage and rights of patent holders.
Optimizing enterprise information security compliance
By VeriSign Inc.
White paper
This white paper by VeriSign explains information-security compliance and auditing among companies that must contend not only with internal, federal and industry-specific regulations and policies, but also with security practices and requirements of their networked partners, suppliers and customers.
FDA, HIPAA and clinical research
By Compliance Gurus Inc.
White paper
This white paper by Compliance Gurus Inc. identifies the similarities between HIPAA regulations and the FDA's Code of Federal Regulations and explain why the healthcare, drug and medical device industries must be mindful of both sets of federal regulations when conducting clinical research.
Speed, communication and high-quality science for biopharmaceuticals
By MDS Pharma Services
Case study
In this case study, MDS Pharma Services provides Roche Pharmaceuticals with speedy turnaround and high-quality service on lot-to-lot validation and other biosafety tests needed for a Food and Drug Administration audit.
Understanding and implementing efficient analytical methods development and ...
By AAI Pharma Inc.
White paper
This white paper by AAI Pharma describes the development and validation process for investigational new drug, new drug and abbreviated new drug application submissions, and advances in analytical methods development and the validation process.
Method validation for laser diffraction measurements
By Malvern Instruments Ltd.
Application note
In this application note, Malvern Instruments Ltd. describes the need for method validation for and outlines some of the important variables that should be assessed when considering the precision of laser diffraction measurements.
Regulatory compliance and validation services
By ABB Inc.
Product collateral
ABB’s regulatory compliance services can assist in dealing with the increasing demands and complexity of national and international regulations.
Validated HPLC columns
By MAC-MOD Analytical Inc.
Application note
In this application note, MAC-MOD Analytical Inc. describes a method of validating high-performance liquid chromatography (HPLC) columns that assures constant column performance over the lifetime of an analytical method.
Taking the mystery out of maximum allowable carryover (MAC) calculations for ...
By GE Analytical Instruments
Application note
This application note by GE Analytical Instruments presents a step-by-step understanding specific for establishing acceptance criteria limits for cleaning with the use of total organic carbon (TOC).
Validating the TOC method for cleaning validation applications in the ...
By GE Analytical Instruments
Application note
This application note by GE Analytical Instruments provides examples of parameters as they relate to total organic carbon (TOC) method validation, including detection and quantitation limits.
Cleaning validation references
By Alconox Inc.
Application note
In this application note, Alconox Inc. describes cleaning validation for pharmaceutical and medical devices. It explains how to identify residues, select a sampling method and writing procedures and training, and offers a directory of methods for each detergent, among other tips.
The right analytical method for the right application: TOC analysis for ...
By GE Analytical Instruments
White paper
This paper investigates the advantages of using a non-specific method, TOC analysis, for cleaning validation and shows how using Sievers TOC technology can improve yields, equipment uptime, and the plant's bottom line.
