A Sample of Our Service Offerings Include:
• Compliance Solutions
• Computer Systems Validation
• Laboratory Equipment Qualification
• Manufacturing Equipment Qualification
• Auditing
• Procedure Development
• Training
• Technology Solutions
• Project Management
Solutions
ValDevTec, Inc. provides compliance solutions to the life science and related industries. Our experienced consultants combine technology, business, and regulatory expertise to deliver innovative solutions to our clients. Whether it’s project management, computer system validation, regulatory compliance, process/equipment validation, SOP development, auditing, problem solving, or training our consultants have the skills to satisfy your business needs.
Computer System Validation and Equipment Qualification
ValDevTec’s services include all facets of regulatory validation. We develop robust computer system validation packages that will meet regulatory requirements. Our validation services include some of the following areas (we can work with our clients to provide other solutions):
• Validation Planning
• Computer Systems Validation
• 21 CFR Part 11 Program Development
• Gap Analysis
• Vendor Audits
• URS, FRS, DS Development
• Risk Assessments
• Protocol and Script Development
• Traceability Matrices
• Equipment Qualification
• Infrastructure Qualification
• Retrospective Validation
• Summary and Final Reports
Auditing
ValDevTec, Inc. provides auditing experience regarding Federal Regulations for the validation of computer systems and regulated manufacturing areas and supporting systems. We review your systems and associated documentation for compliance with current Federal Regulations and industry practices, offering remediation recommendations for risk areas. We also perform Regulatory Audits including vendor audits and internal audits.
Procedure Development
ValDevTec, Inc. provides procedure development solutions from writing a single procedure (Policy, Procedure, Work Instruction) to developing an entire quality management system.
• Development of Quality Manuals
• Methodology Development
• Policy/Procedure Development
Training
ValDevTec, Inc. offers a variety of training services which can be made available to your organization. Our training services include:
• Quality System Regulations
• 21 CFR Part 11
• GMPs, GLPs, GCPs, Good Documentation Practices
• Part 820, 210, and 211
• CSV Training
• Effectively Managing Your System Through Change Control
Technology Solutions
ValDevTec, Inc. can define, create, implement and validate custom software systems for regulated industries. We have expertise in the following areas:
• Visual Basic
• SQL / SQL Plus / PL/SQL
• SAS
• Object Oriented Programming
• MS Access
• ORACLE
Project Management
A trained and knowledgeable Project Manager is a key component to the successful implementation and validation of a system. ValDevTec, Inc. can provide experienced Project Managers to assist our clients with planning projects, forecasting costs, and ensuring on-going communications are established within the project team. Using the proper tools and techniques, we can prevent unnecessary overruns and keep the project on schedule. We work closely with our clients to include them in the overall process.