Government
PRODUCTS
-
Become compliant with FDA 21 CFR Part 11 and EudraLex Annex 11 software validation
SoftMax® Pro 7.2 GxP Software is the latest, most secure software to achieve full FDA 21 CFR Part 11 and EudraLex Annex 11 compliance with streamlined workflows to ensure data integrity. Every step is optimized to simplify analysis and reporting to support our microplate readers.
-
ProPharma has deep expertise across all signal detection and management activities, including validation, prioritization, and assessment using data from a wide range of sources that are relevant for signal detection for the individual product(s). We are also fully trained and experienced in the EudraVigilance Data Analysis System (EVDAS) functionality and can support MAHs to comply with their obligations for signal detection and management. We leverage our robust knowledge to select the most efficient and effective method(s) for each product that is compliant with legislative requirements.
-
With our global network of facilities and services, Cryoport Systems is a strategic partner of choice for temperature-controlled supply chain management of critical materials.
-
Legacy paper trails are a compliance nightmare.
Missing documents, illegible handwriting, and inconsistent data leave you scrambling and vulnerable during audits. Digital CQV captures data and objective evidence in real time, ensuring a crystal-clear audit trail with time-stamped entries and electronic signatures that meet 21 CFR Part 11 requirements.
-
TrialKit requires minimal training for quick deployment. Its open API integrates seamlessly with databases, ideal for fast patient registry studies and high-quality data.
WHITE PAPERS AND CASE STUDIES
-
Maximize Efficiency Of Meter Reading With A Cellular Network
Explore how a utility was able to improve their level of service to the community, increase accuracy in water metering and ensure safety for meter technicians.
-
Building A High-Quality IND From Scratch With Strategic Gap Analysis
A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).
-
Bio-Based Polymers Towards Net Zero In Single-Use Bioprocessing
Decarbonizing healthcare and pharmaceuticals is vital to meet climate goals and safeguard public health. Learn why these energy-intensive sectors must act swiftly to reduce emissions and navigate complex global supply chains.
-
Developing Effective Procedures
Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.
-
The Ripple Effect: A Digitalization Playbook
As the water sector takes on the escalating challenges of accessibility, affordability, and resilience against climate change, digital solutions have demonstrated the potential to transform water systems.
-
Pharma Manufacturing: Top 10 Pitfalls To Avoid
Pharmaceutical manufacturers face constant challenges and pitfalls common to the industry, but how can you avoid and overcome them to mitigate risk across the board?
-
Exploring Open Collaboration In The Water Industry
This white paper will explore the necessity of open data, open software, and open collaboration in the water sector.
-
GSK And Medable Discuss The Next Phase Of DCTs
GSK and Medable share the value of embedding DCTs into strategic goals to enhance trial accessibility, diversity, and efficiency.
-
Cultivate Innovation And Growth At Smart, Connected Facilities
As the US and Europe continue to lead the way in addressing a growing demand for healthcare products, explore how the global biotechnology sector is maintaining momentum and confronting future challenges.
-
eTMF As A Factory: Elements For High-Volume, High-Quality Processing
In an ideal scenario, the eTMF would operate like a well-oiled factory. Examine some of the key factors that would support making “The eTMF Factory” a reality.
-
Rescuing A Phase 1 Oncology Trial: Long-Standing Experience Saves Study Momentum
Study transitions are inherently challenging. Here’s what teams should know to stay informed, keep processes aligned, and successfully transfer data.
-
Incremental Adoption Of A Modular Operations Platform
Discover the potential of a modular operations platform that scales the benefits of digitalization and aids organizations in implementing a unified data strategy to realize the full potential of smart manufacturing.
NEWS
-
AtkinsRéalis Welcomes UK Infrastructure Pipeline7/17/2025
The UK Government has today launched a new Infrastructure Pipeline and interactive online tool providing real-time updates on more than 780 planned infrastructure projects across the UK.
-
Paperless Innovations' Solutions Now Available On Carahsoft's GSA Schedule And Additional Contract Vehicles2/22/2024
Paperless Innovations, Inc., the leading provider of government purchase card (GPC) compliance automation solutions, and Carahsoft Technology Corp., the Trusted Government IT Solutions Provider®, today announced that Carahsoft has added Paperless Innovations’ GPC compliance automation products to its GSA Schedule.
-
City Of West Haven, CT, Modernizes Procurement With OpenGov2/28/2025
Relying on paper-based processes and limited vendor engagement, West Haven leadership needed a modern solution to increase competition and streamline procurement.
-
EPA Invests $20M In Water Workforce Training And Career Development As Part Of Investing in America Agenda7/11/2024
Today, July 11, as part of President Biden’s Investing in America agenda, the U.S. Environmental Protection Agency is providing over $20M to 13 workforce development organizations across the nation under its Innovative Water Workforce Development Grant Program, which supports expanding career opportunities in the drinking water and wastewater utility sector.
-
Carahsoft And Samsara Partner To Bring Public Fleet Management Solutions To The Public Sector5/22/2024
Samsara Inc., the pioneer of the Connected Operations Cloud, and Carahsoft Technology Corp., The Trusted Government IT Solutions Provider, today announced a partnership.