This short video explains, in simple terminology,
what Computer System Validation is,
and how it saves your company money!

Lab5 - Webdesign Schweiz 

DatStat

http://www.datstat.com/edc

DatStat offers a validated EDC/CDMS that’s perfect for sponsors, CROs, and investigators seeking real-time interactions with their patients, research participants, and providers. Our platform includes best-in-class eCRFs, multi-site and multilingual support, remote (offline) data capture, cross-form validations, and nested eCRFs. Ideal for PROs and post-market surveillance surveys. DatStat clients get exceptional data quality, unmatched functionality, DIY forms, and expert support at an affordable cost, so they can deliver improved health outcomes around the world. Based in Seattle, WA since 1997.

 

DocXellent

www.docxellent.com

DocXellent (formerly Mystic Management Systems) has been providing reliable trusted solutions to companies from the Fortune 500 to small businesses since 1983. DocXellent 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.

GxP Statistics

www.gxpstatistics.com

GxP Statistics specializes in advanced biostatisticial techniques, the prediction of events and non-linear modeling. With over 30 years of experience, the consultants at GxP Statistics have participated in medical device development and approval, clinical pharmaceutical trials, FDA submissions, journal article and patent writing and expert witness testimony, both in court and before the Congress of the United States of America. GxP Statistics will integrate professional statistical analyses with your QA system.

Icon Systems Consulting

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.

Increase Your Productivity

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.

Janet Gough

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.

Leland Hirschman

www.lelando.com

Leland Hirschman is a graphic designer, web developer, artist, musician, entertainer, and so much more! His motto, "Creativity for Hire," tells you instantly that his services know no limits! If you need a creative solution to nearly any problem you have, Leland will surely have the answer.  He is responsible for this website's development, as well as all of our design and development needs.

Matrix - Systems & Solutions

www.matrix-ssi.com

Since 1993, Matrix has been implementing highly controlled printing and serialization solutions in a wide variety of packaging line environments. Our 21CFR Part 11 compliant systems ensure a secure, auditable, and accountable packaging line backed by track-and-trace to the individual unit level. Matrix has worked with companies ranging in size from single-factory operations to Fortune 500 corporations and can accommodate the unique needs of any business.

QD-Quality and Training Solutions, Inc.™

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.

QST Consultations

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.

Quality and Regulatory Compliance

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.

SageKey Software

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.

David's Books

One of the nation's foremost experts on CSV for 21 CFR Part 11, David Nettleton has written four books with Janet Gough:

Risk Based Software Validation
Risk Based Software Validation - Ten easy Steps

Electronic Record Keeping
Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164

Managing the Documentation Maze
Managing the Documentation Maze
Read a Review

Commercial Off the Shelf COTS Software Validation
Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance

See the Books page for more information and to order.