LabCentrix^SM has extensive experience in laboratory equipment and processes, IT systems and applicable regulatory compliance guidelines to help you successfully fulfill your validation requirements. Customers use our services to objectively confirm and demonstrate that their computerized systems meet user needs and acceptance criteria.

Our experts draw from deep laboratory informatics knowledge and follow a thorough protocol to qualify software, hardware, documentation and personnel training according to FDA and GAMP guidelines.

Service Offerings

• System Evaluation assessing user requirements, including regulatory compliance as well as documentation and procedures.
• Project Planning/Management ensuring that critical validation activities such as user acceptance testing are properly managed.
• Documentation Development delivering user-friendly documentation, including validation project protocols, master plan and documentation templates.
• Summary Reports of all Testing including user acceptance testing.
• Archival Maintenance protecting signed validation protocols, validation data sets, results, test logs and error logs, memos and reports.
• Validation-related Training equipping customers with the proper skills, knowledge and tools needed to undertake validation activities.
• Pre-audit Evaluation assessing user requirements, regulatory compliance, documentation and procedures.
• Periodic Maintenance and Assessment ensuring compliance on an ongoing basis.
• Upgrade and Migration Revalidation Assistance confirming that solution enhancements, upgrades and migrated code meet compliance requirements.
• General Validation Consulting providing needs and risk assessments, project planning, GAMP methodology and other advisory services.
• Vendor Auditsperforming evaluations on third-party vendor products to assist customers with their selection process.
• Risk Assessment identifying GxP risks, defining business risks and developing mitigation plans according to FDA guidance (where applicable) and GAMP recommendations.

"We objectively follow FDA and GAMP regulatory compliance guidelines."