In November of 2013, the Federal government in the United States passed the Drug Quality and Security Act (DQSA) to create a national pharmaceutical serialization and track & trace regulation. This mandates serialized coding on primary and secondary pharmaceutical packaging beginning in 2017, and supersedes all state mandates (including California e-pedigree). Global traceability initiatives, such as the DQSA, are designed to hinder the production and distribution of life-threatening imitation or counterfeit pharmaceuticals. These initiatives can require identification and authenticity features on primary, secondary and tertiary packaging levels typically in the form of unique, non-predictive, serialized and machine readable codes. This level of product identification aims to impair the ability of counterfeiters to successfully replicate pharmaceutical products and packaging.
Create unlimited mobile forms that replicate your existing paper forms.
DSI offers its expertise on high quality testing capabilities for many types of resources such as in-house produced materials, as well as independent verification of external coated and uncoated samples for vendor/supplier surveillance, process analysis, and qualification testing. Each quality system is ISO 9001:2008 certified and ITAR registered and compliant. Environmental testing is also available and is performed in accordance with military specifications.
Owner/Executive Coaching is a one-on-one engagement with the principal(s) of the business. These typically are focused on one or two areas of the business where the principal does not have experience or is struggling with implementing a solution. Executive Coaching is also used to help accelerate the company’s growth and ensure your growth objectives are met.
Clinical Reach is an enterprise strength cloud-based technology platform that enrolls, engages, connects, and reports on subjects anywhere in the world through a single interface.
Speed is critical to loan origination to ensure enough time for due diligence, to resolve any exceptions before they impact borrowers or create compliance issues, and to avoid funding delays.
Digital transformation has moved the service sector from the periphery of enterprise operations (i.e., a necessary cost of doing business) to an increasingly pivotal role as a profit center, revenue stream and competitive differentiator in terms of customer satisfaction. How?
“Digital born data” is found everywhere in regulated Good Practice environments for laboratory (GLP), clinical (GCP), and manufacturing (GMP) purposes, e.g., (GXP).
With a proliferation of cloud-based technologies already improving clinical trial performance, it is surprising that Excel spreadsheets are still a predominant force. Research dating back to the late 1990s and early 2000s documents that Excel was not designed to collect and analyze clinical trial data and it lacks project management capability, yet its extensive use persists.
Standard Operating Procedures (SOPs) have long been fundamental to many industries, and the clinical trials sector is no exception. With the advent of the Good Clinical Practice Guideline in 1996 from the International Conference on Harmonisation (ICH-GCP), stakeholders have been motivated to develop SOPs, not only for regulatory compliance, but also as a routine business practice. Yet, too often, after companies devote significant time and resources into creating SOPs, they may not be followed.
Like many research and development (R&D) organizations, this global biotechnology company operated in a paper-based environment. Research data was captured in Excel documents and printed and pasted into notebooks making it hard to know where specific information was recorded. Past experiments were not easily searchable with standardized formatting, contributing to a 25% duplication of work rate across the lab.
Purpose-built SSU solutions track clinical trial operations using much needed standardized performance metrics.
Naviant boosts productivity on its document conversion jobs by as much as 87 percent with the OPEX Falcon® document scanning workstation.
The value of rugged tablet PCs may not be widely recognized among consumer audiences, but they often play a direct role in the manufacturing, delivery, installation, and maintenance of goods that impact both our personal and professional vitality, such as food, natural resources, appliances, automobiles, and airplanes.
Organizations are being overwhelmed by malware and potentially unwanted applications (PUAs) such as spyware and adware. While malware and PUAs have been top-of-mind for organizations for years, 2017 brings a significant increase in the level of concern. Even though organizations continue to invest more and more of their IT budgets in security technologies, more attacks are succeeding. In particular, the popularity of ransomware has rapidly increased and it’s causing major operational problems and damage to organizations’ reputations.
Digital transformation is changing the face of commerce. Businesses are introducing technologies in innovative ways to reduce cost, create revenue opportunities, and improve the customer experience.
The path to growing a sustainable service business has changed. New research suggests that best-in-class service organizations can better orchestrate mission-critical field processes for today’s demanding customers by unlocking the potential of the right connected technologies today.
Martin Kropelnicki testified on behalf of California Water Service Group and The National Association of Water Companies (NAWC) today before the House Subcommittee on Environment and the Economy.
DoubleHorn, a leading Cloud Services Brokerage, announced today that they have been awarded a Texas Department of Information Resources (Texas DIR) SaaS contract
The application period has been extended to June 20 for the 2017 Utility of the Future Today Recognition Program. Now in its second year, the program seeks to promote and recognize utilities that are building on a foundation of excellent management and help small, medium, and large utilities transform their operations over time.
Transportation and water infrastructure funding and finance in the United States are not nearly as dire as some believe, but a national consensus on infrastructure priorities, accompanied by targeted spending and selected policy changes, is needed, according to a new RAND Corporation study.
On behalf of the National Association of Regulatory Utility Commissioners, President Robert Powelson of Pennsylvania today sent letters to President-Elect Trump, as well as representatives of his energy and telecommunications transition teams.