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We take a balanced approach towards assisting compliance needs without being a barrier to success.
We understand the complex issues facing regulated industries. Our goal is to help our clients by balancing the compliance requirements with the need for profitable business operations (risk-based solutions). Our validation and compliance practice provides the tools and services to build or enhance your organization’s compliance structure.
High Performance, Low Cost.
Whether you’re looking to upgrade your network, starting a new business, or looking to secure your backup system, we are here to support you with our IT consulting services.
Computer Systems Validations
Our team validates commercial off-the-shelf (COTS), configurable COTS, or custom designed software.
Manufacturing Systems: Manufacturing Floor equipment, PLCs, Supervisory Control and Data Acquisition, Distributed Control Systems and Building Automation Systems
Enterprise Systems: Customer Relationship Management, Sales Force Automation, Enterprise Resource Planning, Sample Management Systems
Laboratory Systems: Laboratory operations (R&D, QA/QC) and clinical development. From bench-top to LIMS
Quality Systems:CAPA, PRISM, Records Management, Document Management, Clinical Trials Apps, SharePoint
Internal and 3rd Party Vendor Audits
Ensure that your company and your vendors stand up to a regulatory audit regarding the validation of computer systems, computer applications, clinical trials and regulated manufacturing areas. This service includes the review of systems and their associated documentation for compliance with current interpretations of federal regulations and best industry practices.
Get an independent assessment of your quality and regulatory readiness for you or your Vendors.
Quality Management Systems
Our team develops quality-related procedures, processes and templates that define the way you conduct your quality organization. This includes:
- Quality Plan
- Change / Configuration Management
- Problem Reporting / CAPA
- Document Retention
Standard Operating Procedure (SOP) Development
Our regulatory solutions include developing business and technical standard operating procedures (SOPs). Our SOP development includes computer systems validation SOPs as well as a wide range of operational SOPs, listed below:
- Disaster Recovery
- Security (physical and logical)
- System Administration and Operations
- Computer Systems Validation
- Document Management
- Software Development Lifecycle
- Change Control/Configuration Management