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Six Sigma Technology
customizes industrial software that maximizes productivity and efficiency
and reduces waste in the process industries. Please run your mouse
over the links below to learn more about our services.
| We provide Validation
services in many aspects of pharmaceutical manufacture, including
services, equipment, system, process, and cleaning. Our objective
is to provide documented evidence to you that, with great
certainty, all parts of the process will consistently work
correctly when implemented. |
General validation activities are:
- Planning
- Specification
- Test Planning (IQ, OQ, PQ)
- Testing (IQ , OQ , PQ)
- Review and Planning
IQ: Installation Qualification
OQ: Operational Qualification
PQ: Performance Qualification
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Six Sigma Technology
can provide the following services:
- Guidance to pharmaceutical manufactures on how to implement
a 21 CFR Part11 compliance.
- Guidance and services to suppliers and clients on what
features are required in their products in order that
pharmaceutical manufacturers may implement 21 CFR Part11 compliant applications.
- Update Validation Plan to cover compliance with 21
CFR Part11.
- Educate users in their resposibility under part11
rule.
- Ensure each new system sanctioned in complaint from
day one, or to establish controls and action plan to address
non-compliance.
- Bring existing system into compliance.
- Provide an assessment tool for use with new systems.
- Document the evidence of compliance with 21 CFR Part11 rules.
- Clear and practical interpretation of the 21 CFR Part11 rules.
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| Six Sigma Technology
is also a systems integrator, providing control, automation
and information technology services to a broad range of industrial
customers. Six Sigma Technology will design, configure and
implement S88.01 compliant batch projects for applications
in chemical, pharmaceutical, and biotech industries. We have
industrial batch experience, including implementation of recipe
management and batch reporting systems.
Our capabilities encompass software
engineering and integration of many systems, including Distributed
Controls Systems (DCS), Supervisory Control and Data Acquisition/Human
Machine Interface (SCADA/HMI), plant-wide Manufacturing
Execution Systems, Laboratory Information Systems (LIMS),
Instrumentation Start-Up/Calibration and Repair, Programmable
Logic Controllers (PLC), and Statistical Process/Quality
Control (SPC/SQC).
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Six Sigma Technology, Inc. provides services
in the areas of Environmental Assessments and Audits. |
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Assessments
- Research of EPA's CERCLA and RCRA lists
- Research of state and local agency files
- Land use history
- Physical site inspections
- Regulatory compliance reviews
- Surface and subsurface investigations
- Remediation management
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Audits
- Record keeping
- Emergency procedures
- Monitoring procedures
- Operating procedures
- Environmental compliance
- Hazardous materials storage and handling
- Waste management
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