Join This Website (Click on Follow)

Monday, February 7, 2011

Testing Computers Systems for FDA/MHRA Compliance



There is no substitute for extensive testing when it comes to IT systems. Recognition that problems are easier and cheaper to fix before the system is in use (rather than after), has turned testing into a cost-effective tool. However, when developing computer systems for pharmaceuticals manufacturing, testing to meet regulatory requirements adds an additional layer of complexity. Testing Computers Systems for FDA/MHRA Compliance focuses on software module, software integration, hardware, and system acceptance testing. Reflecting the renewed emphasis of the FDA and other global regulatory agencies towards systematic inspections and risk-based validation with an underlying scientific rationale, this guide focuses on current best practices in computer systems testing in the regulatory environment. David Stokes demonstrates how the principles detailed in the GAMP 4 Guide can be used to define a pragmatic approach to testing. He includes techniques for testing large Internet-based systems for compliance with the stringent requirements of regulations such as 21CFR Part 11, and clarifies the relationship and responsibilities of the system "user" and "supplier". The author also delineates where testing starts in the project lifecycle, who performs what testing, where the lines of responsibility start and end, and the differences in the terminology used in the healthcare and general IT sectors. A checklist of questions to be used when developing System Test Specification(s), and templates for documenting typical system test results, round out the features that make this book a practical guide for all those involved in the development and implementation of IT systems for the pharmaceutical and related healthcare manufacturing industries. Senior managers, team project leaders, project team members, and industry trainees, will all benefit from this clear and practical guide.

Read more...

Laboratory Auditing For Quality and Regulatory Compliance



Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance


Read more...

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition



Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition
focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.

Read more...

HVAC Equations, Data, and Rules of Thumb, 2nd Ed.



The Latest Information and “Tricks of the Trade” for Achieving First-Rate HVAC Designs on Any Construction Job!
HVAC Equations, Data, and Rules of Thumb presents a wealth of state-of-the-art HVAC design information and guidance, ranging from air distribution to piping systems to plant equipment. This popular reference has now been fully updated to reflect the construction industry's new single body of codes and standards.
Featuring an outline format for ease of use, the Second Edition of this all-in-one sourcebook contains:
  • Updated HVAC codes and standards, including the 2006 International Building Code
  • Over 200 equations for everything from ductwork to air-handling systems
  • ASME and ASHRAE code specifications
  • Over 350 rules of thumb for cooling, heating, ventilation, and more
  • New material including: coverage of the new single body of construction codes now used throughout the country
Inside This Updated HVAC Design Guide
• Definitions • Equations • Rules of Thumb for Cooling, Heating, Infiltration, Ventilation, Humidification, People/Occupancy, Lighting, and Appliance/Equipment • Cooling Load Factors • Heating Load Factors • Design Conditions and Energy Conservation • HVAC System Selection Criteria • Air Distribution Systems • Piping Systems (General, Hydronic, Glycol, Steam, Steam Condensate, AC Condensate, Refrigerant) • Central Plant Equipment (Air-Handling Units, Chillers, Boilers, Cooling Towers, Heat Exchangers) • Auxiliary Equipment (Fans, Pumps, Motors, Controllers, Variable-Frequency Drives, Filters, Insulation, Fire Stopping) • Automatic Controls/Building Automation Systems • Equipment Schedules • Equipment Manufacturers • Building Construction Business Fundamentals • Architectural, Structural, and Electrical Information • Conversion Factors • Properties of Air and Water • Designer's Checklist • Professional Societies and Trade Organizations • References and Design Manuals • Cleanroom Criteria and Standards.


Read more...

HVAC: Systems and Equipment (SI Edition)



The 2008 ASHRAE Handbook—HVAC Systems and Equipment discusses various systems and the equipment (components or assemblies) that comprise them, and describes features and differences. This information helps system designers and operators in selecting and using equipment.



Read more...

All ICH Guidelines



The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
The purpose is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.


Read more...

Disclaimer


I don't share or hack any of website, university databases or Personal accounts and I have discovered all the links from Famous Search Engines. Moreover these links & proxy access are for educational purpose and not for any Business purpose.

With the best of my knowledge, the website does not infringe any of terms and conditions. If still any of content hereby violate any copyright content and terms Please contact me at my email pharmeducare@ymail.com, I'll remove the contents without delay.

Powered by Blogger.

  © Blogger template AutumnFall by Ourblogtemplates.com 2008

Back to TOP