www.ExpeData.net
This 21 CRF Part 11 compliant product captures handwriting on paper documents, including secure signatures, and provides searchable PDFs, clean data and secure images. Ideal for document approval, clinical trials, and form-based data capture. This is the fastest way to electronically publish an approved paper documents, and is compatible with all document/clinical management systems. It is easily deployed, with minimal training, and users like it. |
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www.IconSystemsConsulting.com
Icon Systems has worked with companies to select, install, and support ERP packages since 1995. They are independent of any software vendor and work with their clients to find the best ERP package for their needs. |
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www.qstconsultations.com QST Consultations, Ltd., founded in 1974, is an independent statistical consulting firm that specializes in clinical study and case report form design, data management, biostatistical analysis, medical writing, and complete management of eCTD submissions. The company’s involvement includes many successful phase 1-3 and post-marketing clinical studies designed to support 510(k), PMA, ANDA, and NDA submissions, along with ongoing marketing activities. QST currently works with a range of clients that extend from small start-up organizations to well-established leaders in the pharmaceutical and medical device industries. |
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www.sagekey.com
We employ a repeatable, controlled, disciplined Quality Assurance methodology to design, build and validate software. We are a healthy company with a successful track record - fourteen years, six hundred projects, and satisfied customers in 14 countries. SageKey focuses on developing and maintaining defect free software, and providing outstanding customer service and support. |
www.GxPDocumentation.com
Janet has extensive experience as a consultant to the pharmaceutical, medical device, and biotech industries. She assists companies in designing compliant systems and provides documentation and training. She also co-authored the three books listed on the 'Books' page of this website. |
www.securesoftwarecertificate.com
 As an independent and trusted third-party, we audit Software Vendors and Value-Added Resellers. Only those audits that receive superior results will receive a Secure Software Certificate. Certification provides assurance that the software has passed a rigorous audit that allows you to compare vendors and products against a uniform standard of quality and security. You can also be assured that your software meets the highest standards in software security, electronic signatures, regulatory compliance, and overall quality. |
www.qaaudit.com
Accelerated timelines may require more than the available in-house staff. We can help meet your GXP program needs. Quality and Regulatory Compliance will help pharmaceutical, biotechnology or medical device firms with expertise in auditing and regulatory compliance. Let us perform your audits of Contract Research Organizations and support laboratories. |
www.marssound.com
Mars Sound specializes in complete media production, graphic design, and live sound for concerts and other events. Although we specialize in the music industry, we are available and ready to help you look and sound your best in any industry. |
www.mysticmsi.com
Mystic Management Systems has been providing reliable trusted solutions to companies from the Fortune 500 to small businesses since 1983. Mystic Management Systems provides affordable, easy-to-use, web-based, off-the-shelf total Quality Management Solution for Document Control Systems (DCS), Packaging/Specification Management, Corrective Action & Preventative Action (CAPA), and Employee Training needs.
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www.qd-qts.com
QD-Quality and Training Solutions provides clinical quality systems development (e.g., SOPs) and training services to the biotechnology, medical device and pharmaceutical industries in the conduct of clinical research. Our approach is based on sound quality management principles, regulatory agency and industry driven requirements. |
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