Valicom is experienced with validation of a wide variety of computerized systems. Validation ensures compliance with applicable regulations and guidances, including those for data integrity, while assuring that your systems meet your business objectives.
Some of our areas of expertise include:
Development and maintenance of lifecycle (SDLC) documentation, including validation plans, requirement specifications, risk assessments, design documents, validation protocols and reports, and traceability matrices. We leverage the contemporary, pragmatic, risk-based approach of ISPE’s GAMP 5 2nd Edition to keep your SDLC manageable, focused, and efficient.
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 documenting requirements, and the validation of reports, custom tables and forms, labels and barcodes, as well as 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 (HPLC, GC, CE), including validation of networked data systems (e.g., Agilent ChemStore, Waters Empower).
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 assessment 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. We’ve also developed vendors’ validation packages.