Products and services for data and information analysis, management and training for the pharmaceutical and biopharmaceutical industry
The Windshire Group offers a comprehensive suite of industry leading products and services for data and information analysis, management and training to assist with the demands of the pharmaceutical and biopharmaceutical industry.
Continued Process Verification
- The Windshire Group can implement CPV solutions for continued process monitoring and life cycle management of their process, manufacturing, and QC testing, and quality metric data. Organizations can either host the software or access it and their manufacturing and process data through our secure ARCC cloud offering (see below).
Stability and Shelf Life
- Stabilityshiresm, led by our Chief Stability Scientist, is a consulting service that can assist organizations with any and all aspects of analysis, reporting, and management of stability and shelf life data for intermediate, API/drug substance, and drug product. For compliant reporting and regulatory filings, the service uses a validated software package that is part of our GMP quality system.
e-Submissions and Publishing
- RegDocs365sm is a complete e-CTD submission, publishing, and management solution that meets global regulatory requirements. The RegDocs365 management system is offered with simple pricing models, and can be implemented quickly without the need for extensive internal IT resources. Windshire’s subject matter experts can guide you and manage every step of the way in regulatory submissions.
Compliant Cloud Hosting, including Quality Management Systems and Solutions
- ARCCsm (Audit Ready Compliant Cloud) is the industry leading 21 CFR Part 11 compliant hosting solution for quality related software to the regulated life science industry. ARCCoffers various quality management cloud-based software solutions, including ProcessPad, RegDocs365, and various QMS (quality management system) solutions and modules (e.g. SharePoint, FormPipe): LMS (learning management), eDMS, (document management), deviation/CAPA management, change control, complaint management, and more.
- ARCC is the most economical and fastest way for organizations to implement, validate, and maintain compliant quality related software systems “off-the-shelf” with simple pricing models. ARCC serves the needs of small to large organizations and easily scales and configures to organizational needs and growth.
- We can help organizations pick the optimal solution, and assist with implementation and optimization, including the design of lean, robust quality processes.
Virtual Quality and Process Management Staff Solutions
- Assurashiresmis for virtual, small and mid-size companies that could benefit from augmented staff providing virtual quality or continued process verification management functions and services. Using ARCC, Windshire can provide a virtual quality management support, and provide technical support and expert process monitoring and reporting services remotely. Organizations benefit from better compliance and lowered operating costs, while accessing superb, experienced talent.
- Customized training through our Trainingshiresm service can be developed to assist your personnel in being more effective and increase your organization’s compliance. The customized training can be delivered on-site, or via custom webinars (live or recorded) or training sessions over the web.
For more information on how our consultants, products, and solutions can help you succeed, please contact us today at firstname.lastname@example.org or call (+1) 844.686.5750.