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.
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
Set your eQMS foundation with a comprehensive set of ready to use core quality processes
Compliance Xpand
Build upon core eQMS, expanding into other manufacturing quality and compliance specialty areas
Enterprise Xact
Tailored eQMS, with customized and configured quality and compliance processes based on your unique requirements