Expert in Regulatory Compliance Solutions and a well-rounded professional with solid experience in the life sciences industry regulatory audits such as 21 CFR Part 11, Part 211 and Part 820.
We can provide regulatory support with multiple validation life cycles to include preparation of validation plan and user requirements & functional specifications; writing and executing test scripts based on requirements & specifications; managing traceability matrices; communicating non-conformances with business liaisons; and reporting validation results. With heavy validation strength in ERP systems, particularly SAP.
Development and validation of Laboratory Information Management Systems (LIMS), including implementations for QC testing, environmental monitoring, stability testing, and clinical trial data management. We’re familiar with validation of customizations, including helping with documenting requirements, and validating reports, custom tables and forms, labels and barcodes, and lab equipment interfacing.
Development and validation of Electronic Document Management Systems (EDMS) and Quality Management Systems (QMS), including documentation of requirements and system design.
Design and validation of custom databases and spreadsheets, including validation of macros and Visual Basic script.
Configuration and validation of laboratory chromatography systems Configuration and validation of laboratory chromatography systems (HPLC, GC, CE), including validation of networked data systems .
Validation of laboratory and process test instrumentation, such as spectrophotometers, spectrometers, TOC analyzers, sequencers, tablet testers, and checkweighers.
Development and maintenance of lifecycle documentation, including validation plans, requirement specifications, design documents, validation protocols and reports, and traceability matrices.
Risk analysis to guide and focus validation efforts.
Preparation of procedures and work instructions for the use, management, administration, and change control of computerized systems.
We’re familiar with many vendors’ validation packages and the ways to integrate them with your quality systems and internal practices. We’ve produced supplemental life cycle documentation as needed to ensure that your computerized systems meet your unique requirements.