Manufacturing
Solutions

Operational Excellence with
Electronic and Digital Reporting

THE CHALLENGE

Embracing Quality 4.0

More and more life science companies are embracing not only manufacturing 4.0 principles, but also Quality 4.0. Best in class manufacturers now demand a completely digitized quality and compliance manufacturing and reporting process that spans across the entire supply chain.

It’s Time to Digitize

Manufacturing products in an efficient, cost effective, and compliant manner is not an easy task. It is critical to continuously increase efficiencies without negatively impacting operations, and product quality or regulatory compliance.

THE SOLUTION

Converging Performance & Quality

Electronically monitor, manage, track, document, and report on quality processes to ensure the production of manufactured products that are compliant with global standards and regulations. Eliminate paper trails and human error by harmonizing processes across the entire manufacturing ecosystem.

Cost effective deployment

Off the shelf ready solutions, based on best practices allow for a speedy install

Go paperless

Eliminate paper with digital document control

Data integrity

Automate manual batch record and manufacturing reports with Electronic Batch Record (EBR) management

Off the shelf ready solutions, based on best practices allow for a speedy install

Eliminate paper with digital document control

Automate manual batch record and manufacturing reports with Electronic Batch Record (EBR) management

Cost effective deployment

Go paperless

Data integrity

PROCESSES COVERED

Pharmaceutical

  • Electronic Batch Records
  • Worksheets/Electronic Forms
  • Environmental Management
  • Stability Study Management
  • Batch Release Process (QA/QP)
  • Batch Certification
  • Integration with ERP

Medical Device

  • DMR (Device Master Record)
  • DHR (Device History Record)
  • Electronic Worksheets
  • QA Release
FEATURES & BENEFITS

Ensuring Operational Efficiency

  • Comply with and adhere to regulatory standards (21 CFR Part 11, 21 CFR Part 820, GMP, ISO13485, ISO9000).
  • Electronically enforce process adherence to reduce deviations, CAPAs, and production errors.
  • Ensure operational efficiencies that reduce lead time from initial batch to product release.
  • Seamless integration with MES helps ensure a reduction of recalls through quick identification, containment, risk analysis, and CAPA.

Experience ready to use QMS

Explore Dot’s products

No matter what your quality and compliance needs are, we have a solution for you.

QMS Xpress Symbol

QMS Xpress

Set your eQMS foundation with a comprehensive set of ready to use core quality processes

Xpand

Compliance Xpand

Build upon core eQMS, expanding into other manufacturing quality and compliance specialty areas

Xact

Enterprise Xact

Tailored eQMS, with customized and configured quality and compliance processes based on your unique requirements

FEATURED SUCCESS STORY

Real People. Real Results

Implementing DOT Compliance’s QMS software was a fantastic business decision on our end. The software is very thorough, compliant, and extremely easy to use.

Dan Bowman
Operations Manager, Pinnaql Advanced Scientific Services

Pinnaql