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The Product Quality System is a customized product management system built on off-the-shelf open source Drupal CMS and MySQL Database configured to the company needs. The system is integrated with the overall company IT system, product-quality data storage and the product-quality document control process.

The system is divided into modules: (1) document logs, (2) product development tools, (3) product deployment tools, (4) quality tools and (5) project management. A brief descriptions of each is provided on the menu-page for each.

The system is designed to meet the requirements of the company Quality System and consequently Regulatory Agencies. Some key processes incorporated are illustrated at the links: requirements traceability, development process, standards mapping and configuration management.

Product Quality System (This Web Site)
Architecture Customized product management system built on off-the-shelf open source Drupal CMS. Data are stored in a standard off-the-shelf MySQL database. Standard modules are normally used in order to minimize software development-verification needs.
Installation Hosting vendor, as well as the Drupal and MySQL database (Oracle) suppliers, are approved as suppliers with associated surveys or audit reports.
Installation Verification An installation-configuration specifications is developed. An installation verification is tested (traced) against the verification document.
Intended Use Validation A use work instruction is developed and validated, typically with 3 users. Users are trained to the work instruction and a standard training record is kept. Regression testing after normal (minor) upgrades and modifications is usually conducted by 1 user unless usability is impacted (user-to-user variation).
Training Effectiveness Monitoring Existing or new IR (information reviews) checking actual archive content against the logs are often used as a part of the validation and effectiveness monitoring. These reviews are inputs to standard internal audits.
Key Settings Key settings are documented in the installation and configuration specification. These include user access and roles, access logging, and change tracking.
Overall IT System and Document Control Process
Document Archives Approved documents are stored in a restricted (read-only) archive accessable only by authorized (e.g., QA) representatives. Signed documents are scanned into a non-modified PDF format for archiving. Original source documetns may be stored in a 'supporting docuements' sub-folder for future use and modification but the offical record is the PDF or equivalent file.
Configuration Management The source files for the installation are archived as a software item.
Backup Database files as well as the PDF document archives should be automatically backed up in accordance with the overall company IT approach/system and plan. Verification of backup, preferrably to a separate location, is completed with the backup portion of the overall IT system plan/spec and verification.
Originals (Paper) In order ensure the most recent revision of any document is readily apparent and available, the scanned electronic archive record is considered the official record. However, the paper original is maintained on file until files have passed through a information review (IR) and/or quality audit.
Information Reviews (IRs) Periodic reviews of the logs and content are performed to ensure records are maintained and accurate. A standard checklist isl used and may be a complete review or statistical sample based on the nature and size of the specific document archive. Information reviews are used as input to format internal quality audits, documenting the status and any corrective/preventive actions prior to the summary audit.