Experience Our Technology Expo

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 At CSA QMS, we prioritize excellence in compliance and quality systems that are essential for ensuring the integrity of your processes and product designs. Our expertise encompasses a wide range of services, including meticulous quality control procedures tailored to your specific needs. Each of our consultants is thoroughly trained in quality assurance principles, equipping them to provide you with knowledgeable support. Additionally, our experienced quality engineers are ready to assist with specialized quality assurance requests, helping you navigate the complexities of your projects with confidence and precision.

With over 15 years of experience in life science manufacturing regulatory compliance, CSA-QMS LLC understands the precision required for technical writing. CSA-QMS LLC technical writing consultants know that documentation is critical for all steps in pharmaceutical and medical device development and production. Therefore, our technical writing consultants strictly follow Good Documentation Practices (GDP), which is necessary for GLP and GMP compliance. 

Provide The Followings:

• Project Planning
• Validation Master Plans (VMP)
• Commissioning and Qualification
• User Requirements Specifications (URS)
• Standard Operating Procedures (SOPs)
• Risk Assessments
• FAT & SAT Protocols
• Validation Protocol Format​​ 
• Design Qualification (DQ)​
• Installation Qualification (IQ)​
• Operational Qualification (OQ)​
• Performance Qualification (PQ) 
• Good Automated Manufacturing Practice (GAMP)​
• Current Good Manufacturing Practice (cGMP) Review
• Summary Reports
• Traceability Matrixes

 With over 15  years of experience in life science manufacturing regulatory compliance, CSA-QMS LLC understands the precision required for technical writing. CSA-QMS LLC technical writing consultants know that documentation is critical for all steps in pharmaceutical and medical device development and production. Therefore, our technical writing consultants strictly follow Good Documentation Practices (GDP), which is necessary for GLP and GMP compliance. 

• Investigations
• Procedures
• Manuals
• Performing training on technical documents
• Protocols
• Specifications
• Standard Operating Protocols (SOPs)
• Summary Reports
• Training documentation creation

With over 15  years of experience in life science manufacturing regulatory compliance Such as 

• Batch Records
• Clinical Operations
• Commissioning, Qualification, and Validation (CQV)
• Data Science
• Device History Files
• Device Master Records
• Engineering
• Environmental Monitoring Trend Reports
• Forms
• Global Harmonization
• Installation, Operational, and Performance Qualification (IQ/OQ/PQ)
• Log Books
• Manufacturing
• Methods
• Quality Manuals
• Regulatory Affairs
• Reports
• Validation Master Plan Procedures
• White Papers
• Work Instructions

 Focus on compliance, quality systems, process, and product design, quality control, and more.  consultants are trained in QA, and quality engineers can assist you with specialized QA requests, such as. 

• Change Control Management
• Risk Management
• Quality Agreements
• Customer Complaints Documentation
• Regulatory Inspections
• Regulatory Documentation
• Staff Training
• Review and Approval of Validation Documents
• Internal & External audits
• Audits planned & Executed
• Reports issued
• Vendor audit responses
• Audit close-outs
• Audit Reports including different levels.
• Deviations and Non-Conformance
• Investigation Reports
• CAPA – root cause investigation and implementation of corrective & preventative actions