Laboratory Information Management (LIMS)
Validation Package

Laboratory systems and software are strategic to life sciences companies for supporting manufacturing quality assurance, research and development and clinical trials functions. These systems must comply with the GxP guidelines enforced by regulatory authorities.

Arbour Group can significantly reduce the cost of validation for laboratory information management systems. Our pre-packaged LIMS validation solution is based on our extensive industry knowledge and expertise accumulated from years of experience with leading pharmaceutical, medical device and biotechnology companies. The Arbour Group LIMS solution contains the templates and test scripts that simplify the overall effort required for development of documentation and allow you to meet the meet regulatory obligations to both domestic and international authorities (BfArM, FDA, IMB, MHRA, TGA, etc.).

Arbour Group regulatory specialists have the business process knowledge, technical expertise and regulatory background to assure a timely and cost effective validation of lab management systems

LIMS Validation Test Execution

LIMS Validation Package Benefits

• Reduce testing time by up to 60%
• Scalable solution focused on life science company uses
• Accelerated software deployment
• Company staff time remains focused on critical business activities
• Ongoing support…we monitor regulatory changes and provide test script updates so you stay in compliance

LIMS Compliance Package Maintenance

• Comprehensive assessment of GxP changes and impact to LIMS software functionality as it relates to life sciences industry regulations
• 10 hours of expert-level LIMS consulting on GxP issues
• Modification and development of new LIMS validation test scripts to ensure ongoing compliance

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