MMR offers custom risk based approach to Computer System Validation (CSV). Our CSV experts has experience in creating and executing CSV deliverables for various systems including ERP, LIMS, eQMS, MES, process equipment and many others.
- Cloud based application: (SaaS, PaaS, IaaS)
- Configured Off the Shelf (COTS) packages
- Custom build systems and applications
- Automation Validation: Process Controls (PLCs, DCS, GE Unicorn / Cytiva), BAS Systems (Johnson Controls, Siemens, Honeywell)
- Clinical Trial Management system: Oracle Clinicals
- Enterprise Requirements Planning Systems: SAP, Acumatica, Dynamics 365 and Sage
- Desktop Applications: Excel spreadsheets, SharePoint sites
- Digital Signature: AdobeSign, DocuSign
- Quality Management Systems: TrackWise, MasterControl
- Validation Management system: Kneat, HP ALM
- Manufacturing Control Software: PartMaker, PLCs, DCS (DeltaV, Siemens PS7), GE Unicorn / Cytiva)
- BAS Systems Validation: Johnson Controls, Siemens, Honeywell
- Manufacturing Execution Systems: Werum Pas-X, Siemens EBR, Historian Systems, OSI-Pi
- Pharmacovigilance Systems: Oracle Argus
Implementation of CSV Program
- Provide CSV SOP development such as Risk-based Validation, Change Control, Incident Management, Periodic Review, GxP assessment including appropriate staff training.
- CSV templates such as, Validation Plan, User Requirement, Test Protocols and Validation Report
- Evaluate and assess current procedures and practices vs regulations and industry best practices
- Address compliance gaps by updating current procedure
- Implement risk based methodologies and address inefficiencies
Check out some of our publications on the CSV services we provide.
Working from Home – Our New RealityPharmaceutical company professionals understand the necessity of maintaining schedules and deadlines. In response to the pandemic of 2020, many technologically sophisticated businesses’ IT support teams have deployed the software tools to keep us integrated with our professional communities while observing the new work from home or quarantine limitations being imposed on the workforce. This isRead more