Our Services

Define and establish a better road to compliance in manufacturing and laboratory operations, including all Quality Systems (Process and Laboratory Investigations, CAPA, Change Control, Training, Document Management and Control). 

Helping our clients accomplish the right balance of regulatory compliance and profitable business operations, we assure that our clients establish a complete strategy in a regulated industry, in areas such as: 

• Basic Concepts in Cleaning Validation 
• Laboratory Analyst Certification Program 
• Training on Documentation & Quality Systems 
• Audit and Assessment 
• GxP’s applied to functional area
• New Hires Certification
• Train the Trainer for GMP & Technical Trainings  
• Development of Business Continuity Plan

• Pre-Startup Check List 
• Documents Commissioning 
• Technical Support During Commissioning 
• Qualification Strategy 
• User/ Functional Requirements Specifications
• IQ/ OQ Plans/ Protocols/ Reports
• Maintenance and Operations SOPs Development and On-Site Training 

• 21 CFR Part 11 Assessment & Remediation
• In-depth Computer Life Cycle Validation Strategy/Master Plan
• User/Functional Requirements Specifications
• Vendor Audit
• IQ/OQ Plans/Protocols/Reports
• Maintenance Validation SOP’s Development & Implementation
  (Change Control, Backup, Security, Disaster & Recovery, Periodic System Review)
• Maintenance and Operations SOPs development and on-site training

• Process Validation Life Cycle
• Gap Analysis and Audit validation protocols to ensure that critical information meets regulatory mandates and guidelines
• Cleaning Validation programs for multi-product equipment, including development
  of acceptance criteria
• Development of Sampling Plans for cleaning processes
• Provide laboratory services in cleaning validation (testing of samples as well as conducting rinse/swab recovery studies, dirty equipment studies, etc.)

• Methodology Transfer and Validation
• Validation and Training in Chromatography Software
• System Configuration / Customization to reduce cycle time in documentation process
• Data Migration
• System Support
• SOPs Development

Documentation Review of analytical data in compliance with cGMP, Federal and State
regulatory requirements

Provide consultants to the team that is already established in the company and guide them to the best practices.

Assist in the project to ensure deliverables are delivered on time and within budget as per the business requirements.

Project Management Methodology: 

• Project Initiation 
• Project Planning 
• Managing 
• Executing 
• Controlling 
• Lessons Learned Review 
• Project Closeout

Provide resources with the right knowledge to update new and existing systems/platforms/equipment.