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

Lab5 - Webdesign Schweiz 

Online Computing - MasterTools ERP

Since 1969, Online Computing has helped small to mid-sized businesses across the U.S. utilize the MasterTools software suite to manage work flow, solve problems, and report results.  They provide a complete ERP solution that includes accounting, inventory control, distribution and manufacturing.  It contains 21 CFR Part 11 functionality related to security, audit trails, and electronic signatures. Online Computing offers not only a robust software solution, but a partnership that provides implementation experience, in-depth training, and responsive support, enabling clients to compete in today’s environment. MasterTools users testify that dealing directly with the developers of the software, instead of a reseller or integrator, makes a real difference in their organization's go-live and ongoing experience.

MasterTools is a complete ERP solution that includes core components of accounting, inventory control, distribution and manufacturing. These can be configured to meet the unique needs of different clients. Whether their concern is lot or serial number traceability, predicting material requirements, tracking quality issues, taking physical inventory, or analyzing financial data, clients depend on MasterTools to increase efficiency and productivity.  In addition to the core components, supplemental components consist of e-commerce, a rules-based product configurator, job control, Electronic Data Interchange (EDI), and credit card processing.  Additional integrated solutions include portable wireless scanners, UPS Worldship, FedEx Ship Manager, USPS Shipping, time & attendance clocks, and CCH Sales Tax Database.

Weever Apps - Process Manager

Process Manager is a cloud-based workflow management solution for product quality, safety and compliance. Process Manager includes security and data integrity features required for 21 CFR Part 11 FDA compliance, including audit trails, user permission rules and data encryption. The software helps food, drug, cannabis and CPG manufacturers optimize data capture and workflow efficiency on the production floor, while enhancing real-time operational visibility for managers. 


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 (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.

Icon Systems Consulting

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

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.

Leland Hirschman

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

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.

QST Consultations

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.

SageKey Software

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 several books with Janet Gough, including:

Software as a Service - Risk-Based Validation with Time-Saving Templates

Software as a Service
Risk-Based Validation
with Time-Saving Templates

NEW for 2020!

Managing the Documentation Maze
Managing the Documentation Maze

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

See the Books page for more information and to order.