Document & Quality Management System
Excellent Pharma, Device, Biotech Quality Management Software
Our Document & Quality Management System is perfect for
early-stage pharmaceutical, medical device and biotech firms where
cost-effectiveness, rapid implementation, and flexibility are essential.
DQMS automates all the important functions of your QA group, including
Document Control, Change Control, Training and CAPA, and also addresses
related functions such as Regulatory Affairs and Archiving/Disaster
Recovery.
This is a proven system that has been providing high-quality, cost-effective document management tools since 2000. DQMS was developed to the detailed specifications of Quality and documentation experts at cutting-edge firms. It is a very easy-to-use system designed for quick data entry, with all modules integrated for accuracy and consistency, and extensive search and reporting functions.
Most Cost-effective and Customizable
Because we use standard hardware and software platforms, DQMS can be implemented at a fraction of the cost of other systems. The user interface part of our system is built with Microsoft Access, which results in a very inexpensive and user-friendly environment that is highly customizable. The database uses standard Microsoft SQL Server, which many firms already have installed, but is inexpensive in any case. Many firms won't need new hardware or software to use DQMS, keeping the total cost of implementation much lower than equivalent systems.
Nelson Tech can also quickly customize DQMS to match your unique business needs, again at a much lower cost than you might expect. Since we offer full custom development services, individual DQMS modules can be modified for your purposes, and additional modules can be added. You don’t have to change your business processes to suit somebody else’s software!
DQMS can be implemented for under $40,000 total, including the one-time license fee, customization, installation and setup. Annual licensing is available to further reduce the initial cost. Please contact Nelson Tech for more information and an initial estimate.
Major Modules and Functionality
This system is modular and flexible. We can implement any of the modules you want, or phase the implementation as needed; restrict access to modules to specific user groups; and change the menu system to match your organizational structure and workflow.
- Document Control - configurable document
types and part numbering for controlled documents; revision tracking; references to other
controlled documents; links to change orders; related Products, Keywords,
Lab Result Workbooks and document files; document distribution
tracking;
full search capability with multiple report formats.
- Change Control - Document Change Orders (CCRs)
for internal change control; Change Review with Document, Product and CRB links
and CR Amendments ; and Supplier Documents and Change Control sub-modules; all
with full search capability with multiple report formats.
- Employee Training - tracks required and completed training
per controlled document; clone training from another employee, add training for
entire class; multiple reports for required and completed training, training
gaps, etc.
- Audits - manages Internal and External (Supplier) Audits,
including Audit Nonconformances and related CAPAs, auto creation of printed
Nonconformance form and CAPA form, Status tracking for Audit and NCs, NC Approval
tracking, Search modules for NCs and CAPAs, etc.
- Nonconformances - including tracking of Status and Approvals,
related Products, Lots, Controlled Documents, MRB, Supplier, CAPAs, Root Causes,
Dispositions, and related document files; Amendments; auto creation of printed
Hold form and Nonconformance form; full search capability with multiple report
formats; module has been validated under CFR Part 11.
- CAPA - tracking of Status and Approvals, related Issues,
and related document files; Amendments; auto creation of printed CAPA form;
full search capability with multiple report formats; module has been validated
under CFR Part 11.
- Material/Batch Releases - with material sourcing,
Analytical Tests, Test Results by process step; full search capability
with multiple report formats.
- Notebooks - manages Lab Results Workbooks, with
links to other Workbooks, Laboratory and Adjunctive Notebooks, and
controlled Documents; Revisions and Amendments; full search capability
with multiple report formats.
- Regulatory Affairs - including tracking of Correspondence,
Documents, and External Standards, with links to controlled Documents; full
search capability with multiple report formats.
- Archives - tracks internal and offsite Electronic and
Hardcopy archives for disaster recovery, with links to all major document
types and label printing; full search capability with multiple report formats.
- Clinical Trial Material Releases - tracks by Product, with
related document files; full search capability with multiple report formats.
- Reporting - robust assortment of reports covering distribution
and training notifications, biennial reviews, Document Change Order and
Nonconformance aging, overdue CAPAs, and much more.