Pace Analytical Services, Inc. Method development & validation, stability testing and storage, raw material testing, compendial testing, release testing, drug/device combination product testing, microbiology testing, extractables/leachables testing,...
Environmental Testing Services
Pace Analytical Services offers extensive capacity for organic and inorganic analysis as well as a broad range of specialty services, which allows us to...
Affygility Solutions Providing potent compound safety, control banding, compound categorization, occupational toxicology, chemical toxicology, industrial hygiene, OSHA compliance support services to the biotechnology, pharmaceutical, medical...
Environmental Health and Safety Auditing
Environmental Health and Safety (EH&S) audits are a proven tool that will enhance a company's EH&S and business performance. It is standard practice among...
Rees Scientific From unwavering temperature monitoring in refrigeration, freezing and incubation, to lighting, humidity and automated watering for animal laboratories, Rees Scientific provides automated environmental monitoring and...
Intelex Intelex Technologies Inc. is North America's leading provider of software systems designed to drive continual performance in environmental, quality, health & safety and business performance management.
AIRY TECHNOLOGY INC Airy Technology Inc is a manufacturer of environmental testing instruments including particle counters, anemometers, IAQ monitors, gas monitors.
Quantum Compliance Systems, Inc. Quantum Compliance Systems specializes in EHS&R Information Management System products for environmental, health, safety and risk compliance reporting, KPI tracking, and sustainability reporting.
Professional Services Group
Quantum Compliance Systems’ Professional Services Group (PSG) is tasked with providing our customers with the highest quality, fastest response, and...
ESS ESS is the leading provider of Environmental, Health & Safety (EHS) and Crisis Management sustainability software. For nearly two decades, ESS has provided software that enables organizations to address environmental,...
New Challenges Call for Innovative Approaches 3
Rachel Yang, MD, PhD Director, Product Strategy, Oracle Health Sciences Global Business Unit
Implementation of a Clinical Management Technology System 6
Jennifer Hunt Senior Director, Clinical Research, Genzyme Corp.
Clinical Trials Management of the Future 9
To identify bacteria and fungi, pharmaceutical manufactures rely on curated, compliant and up-to-date libraries. Results of using a proprietary library, based on over 300,000 unknown organisms recovered from environmental monitoring programs, show a two-fold reduction in unidentified strains when compared to a commercially available library.
Moving Beyond Compliance: Reinvention of Enterprise Risk Management
Today’s companies are facing significant chal- lenges in balancing all the regulatory pressures coming from a long list of regulatory agencies from corporate and financial such as SEC, DOJ, CBP, ICE, BIS and OFAC, to operational and product areas such as the FDA, EMA, EPA, ISO and more. Many of these programs are still ...
Electronic Data Capture (EDC) systems should be more than just a means to an end. Quality EDC systems can enable the entire clinical trials information management process. Your diligence in implementing thorough preparation—including edit check specifications and standardized eCRF design—will improve the efficiency of your study, and help you avoid some of the most common pitfalls even an ...
The cost of developing new drugs has been increasing at an alarming rate – approximately 11 percent per year compared with annual drug sales growth of only 6 to 8 percent. At the same time, drug pipelines have been shrinking, putting even more pressure on biopharmaceutical companies to squeeze more out of what they have. Given the serious concerns over the spiraling cost of prescription drugs, ...
BUHLER AEROGLIDE WHITE PAPER: Reducing the Environmental Impact of a Convection Dryer
Global warming, carbon footprint, greenhouse gases; ten years ago, none of us had even heard of these terms, but today, they are on the front page of every newspaper and magazine. You may or may not agree with the science behind global warming, but you cannot ignore the fact that this science will impact how ...
The 21 CFR Part 11 rule states that the FDA view is that the risks of falsification, misinterpretation, and change (without leaving evidence) within the GMP environment are higher with electronic records than paper records, and therefore specific controls are required.
The Veriteq validatable data logging system is a “hybrid” system that employs the use of both electronic records and signed ...
Your company has just developed a new product, and now it is your job to select an environmental chamber to test it. The product must be tested at various conditions to ensure its quality and reliability. Where do you start? What will determine your selection crite- ria? Price, quality, capabilities…. As with any major purchase, sev- eral items must be considered before making the final decision. ...
Calibration, maintenance and validation activity, despite operating within the same department in some organizations, have generally been managed separately, each with their own procedures and their own computerized management systems. Since even calibration and maintenance professionals tend to access records differently and track different types of information, these separate and unconnected ...
Medical Device Manufacturers have always focused on bringing innovative high quality products to market. Yet shifting financial, regulatory and globalization landscapes call for closed-loop product management strategies that can keep up with the increasing innovation tempo and complexity of medical devices while at the same time, lower cost, increase quality, and facilitate compliance with ...
StudyManager Reveal offers groundbreaking ease-of-use, power, and flexibility. Combining the latest web technology with 15 years of customer feedback, ...
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