Compliance Software
FEATURED REPORTS
WHAT'S NEW
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Compliance software: SmartLab Automated Compliance System by VelQuest Corp.
by VelQuest Corp.
Product collateral
SmartLab: Automated Compliance System is a fully validated approach to data acquisition, compliance documentation, storage and retrieval and is suited for laboratories and other procedure-based operations with defined regulatory requirements.
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FDA uses enterprise architecture to standardize and save with consolidation ...
by U.S. Office of Management and Budget
White paper
This white paper outlines the FDA's information technology consolidation solution, driven by an enterprise architecture framework.
REPORTS BY SUBTOPIC
The New Biopharmaceutical Blueprint
By IBM Corp.
White paper
This paper is intended for business executives and explores how SOA can help enterprises effectively achieve business flexibility within a compliant environment.
Geometry Unifies Process Control, Production Control and Alarm Management
By Curvaceous Software Ltd.
White paper
This white paper from Curvaceous Software Ltd. shows how geometric process control (GPC) combines the three key plant applications of process control, production control and alarm management and improves all three.
Fault tolerance is the missing ingredient in the pharma drive for process ...
By Stratus Technologies
White paper
This white paper by Stratus Technologies outlines the pharma industry's need for fault-tolerant computing, based on growing needs for electronic batch record (EBR) and process analytical technology (PAT) information systems.
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.
Global pharma company specifies Honeywell for UK facility
By Honeywell Process Solutions
Case study
In this case study, Honeywell International Inc. provides an integrated enterprise management system to a global pharmaceutical company to reach its environmental monitoring and reporting requirement goals, resulting in cost reduction, energy efficiency and improved asset management.
Automating corrective and preventive actions in FDA environments
By MasterControl Inc.
White paper
This white paper by MasterControl Inc. describes how most companies create a corrective and preventive action (CAPA) program and the elements of successful electronic CAPA systems.
The essentials of stability test services
By MDS Pharma Services
White paper
This white paper by MDS Pharma Services describes the testing that a drug must undergo before it is launched in the market.
CATSWeb Enterprise Quality Tracking System
By AssurX Inc.
Product collateral
CATSWeb is a comprehensive
Modernizing quality control systems
By MasterControl Inc.
Application note
In this application note, MasterControl Inc. describes the quality systems model and how its software automates, tracks and manages document- and forms-based quality processes and employee training.
Managing forms-based quality processes
By MasterControl Inc.
Application note
In this application note, MasterControl Inc. describes its MasterControl Forms, which were developed as part of an integrated solution to help companies manage forms-based processes that are critical in ensuring compliance, efficiency and overall competitiveness.
The New Biopharmaceutical Blueprint
By IBM Corp.
White paper
This paper is intended for business executives and explores how SOA can help enterprises effectively achieve business flexibility within a compliant environment.
FDA uses enterprise architecture to standardize and save with consolidation ...
By U.S. Office of Management and Budget
White paper
This white paper outlines the FDA's information technology consolidation solution, driven by an enterprise architecture framework.
Speed, communication and high-quality science from MDS Pharma Services
By MDS Pharma Services
Case study
In this case study, MDS Pharma Services supports Roche Pharmaceuticals to prepare for an FDA audit by undertaking lot-to-lot validation and other biosafety tests for reagents used in diagnostic kits.
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.
RAPID-Pharma and 21 CFR Part 11
By Automsoft
Application note
In this application note, Automsoft describes how its RAPID-Pharma addresses the FDA's 21 CFR Part 11 regulation, particularly how records are identified, and explains RAPID-Pharma’s support for key Part 11 requirements.
Importance of training control in FDA environments
By MasterControl Inc.
Application note
This application note by MasterControl talks about common stumbling blocks in training management, FDA regulations and ISO standards that require training control, major challenges in implementing training, and how MasterControl's solution can help life sciences professionals address those challenges.
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.
Compliance software: SmartLab Automated Compliance System by VelQuest Corp.
By VelQuest Corp.
Product collateral
SmartLab: Automated Compliance System is a fully validated approach to data acquisition, compliance documentation, storage and retrieval and is suited for laboratories and other procedure-based operations with defined regulatory requirements.
The ultimate quality management system for the chemical industry
By Sparta Systems Inc.
Application note
In this application note, Sparta Systems, Inc. describes its TrackWise quality management system solution and explains how a company can achieve a state of efficient compliance with GMPs, ICH Q7A, ISO 9000, ISO 14001, EH&S regulations, as well as other industry quality standards.
The New Biopharmaceutical Blueprint
By IBM Corp.
White paper
This paper is intended for business executives and explores how SOA can help enterprises effectively achieve business flexibility within a compliant environment.
Engineering standards advance PAT
By IBS Caribe
White paper
This white paper from IBS Caribe discusses process understanding and management, and the engineering standards that promise to bring plug-and-play capabilities to process analytical technology (PAT) to pharmaceutical manufacturing in general, and to Puerto Rico in particular.
21 CFR Part 11: Where are we now?
By Cimquest Inc.
White paper
This white paper from Cimquest Inc. discusses two major changes brought about by the FDA's Guidance for Industry for 21 CFR Part 11: the narrower interpretation of 21 CFR Part 11, and that enforcement discretion is exercised with regard to requirements for validation, audit trails, record retention and record copying.
Experion Qualification and Version Control System (QVCS)
By Honeywell Process Solutions
Application note
In this application note, Honeywell describes the Experion Qualification and Version Control System (QVCS) and how they are embedded with 21 CFR Part 11 compliance tools.
Optimizing asset management to comply with 21 CFR Part 11 requirements
By Infor
Case study
In this case study, Infor helps a leading pharmaceutical company optimize asset management in compliance with FDA's 21 CFR Part 11 requirements.
Getting past the legal hurdles of a global digital signature standard
By Pfizer Inc.
White paper
This white paper from Pfizer Inc. describes the SAFE-Biopharma Association initiative to create a platform based on digital signatures that would preserve the security of intellectual property, business transactions and records.
An enterprise issue, not a point solution
By Clarkston Consulting
White paper
This white paper by Clarkston Consulting shows how life sciences companies can facilitate the FDA's 21 CFR Part 11 regulations through a compliance program office.
The law of electronic records retention for life science industries
By Proskauer Rose LLP
White paper
This white paper by Proskauer Rose LLP describes the legal landscape of records retention law applicable to life sciences companies, including what constitutes a record, electronic signatures and intellectual property issues, and other subjects.
Implementing a global 21 CFR Part 11-compliant CAPA system at Bausch & Lomb
By AssurX Inc.
Case study
This case study by AssurX shows how vision care company Bausch & Lomb used AssurX's CATSWeb system to manage corrective and preventive actions (CAPAs) and provide 21 CFR Part 11 compliance.
Top 10 questions about 21 CFR Part 11 compliance
By Siemens Corp.
White paper
This white paper by Siemens Building Technologies. Inc. answers 10 common questions pharmaceutical engineers might have about 21 CFR Part 11 compliance, particularly electronic records and signatures.
