Validation Strategies for Your Success
- Are you preparing for a regulatory audit of your validated computer systems?
- Does your supporting documentation follow Good Documentation Practice (GDP)?
- Did you know that your FDA-regulated computer systems must be maintained in a validated state throughout their life cycle?
- Do you have an established and ongoing validation strategy?
Whatever your compliance or validation issue — we can help!
Pass Audits with Confidence
You need to ensure that your business and lab systems meet regulatory requirements. The quality and accuracy of your data are vital to the success of your company. Critical systems must function properly to produce consistent results. This means all aspects of your regulated business must be controlled and verified. Systems installation, operation, and maintenance must be documented, tested, and reported accurately and efficiently. Standard Operating Procedures must be documented and followed. You need experienced compliance and validation support that includes current knowledge of FDA and Sarbanes-Oxley regulations and documentation – so you can pass your audits with confidence.
Our Experienced Team Can Help You
Our knowledgeable compliance and validation professionals work with you to develop:
- System configuration specifications
- User requirements specifications
- Validation plans
- Risk assessments
- Test plans
- Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) testing and results
- Validation trace-ability matrix and summary reports
- Technical support
- And more!
We are qualified in FDA validation, including 21 CFR Part 11. Our team of highly skilled experts helps you stay in compliance with all FDA and Sarbanes-Oxley regulatory requirements. We maintain your systems and compliance documentation while you take care of the science.
We’re Here to Support You
When you work with Life Science IT, Inc., you work with an experienced validation team that ensures compliance with regulatory requirements for a fair price. We maintain your technology and guarantee its reliability. We are available for you 24/7/365.
Call (858) 263-1228 or fill in the easy-to-use form on the right side of the screen and we will respond promptly.