Mindlance Validation Staffing offers experienced consultants to regulated businesses such as pharmaceuticals, biotechnology, medical device and related life science industries. We have the expert staff you need to handle your quality, validation, compliance, auditing, and system issues, and ensure compliance with FDA, CE Marking, and ICH guidelines and regulations.
All of our computer system validation (CSV) candidates have experience in GAMP5, GXP and Part 11. On the manufacturing side, we have resources that specialize in commissioning and start-up of production facilities and process equipment and control systems.
Our consultants have experience in:
Assurance and quality engineering; development of complete quality systems, including complaint management, deviation management, CAPA, change control, training, and document management and control; methodology, policy, and procedure development; Gap/Risk assessment; recalls, MDRs and complaint handling; and auditing to determine compliance with applicable regulations, guidelines, procedures, and policies for Part 11, quality systems, vendors, and IT compliance.
Writing submissions, documentation, and remediation including 510k submissions, AERs, PMAs, IDE, remediation/resolution management, technical papers and complaint handling.
Developing Standard Operating Procedures (SOP), Validation Support Processes (VSP), validation protocols (IQ, OQ, PQ), and validation master plans. Conducting validation executions and writing validation reports. Computer systems, software, process, cleaning, methods, facilities and utilities, equipment, IT infrastructure, and 21 CFR Part 11.
We can staff a variety of key validation roles.
- Instrument/Equipment Qualification for Agilent, Waters, Thermo and more
- Lab System Validation (CDS, ELN, SDMS)
- LIMS Systems Validation
- CDMS Validation
- CTMS Validation
- EDC Validation
- IVRS/IXRS Validation
- Business Intelligence Validation – Report qualification for Cognos, Business Objects and Crystal Reports
- Customer Relationship Management (CRM) Validation
- Enterprise Content Management (ECM) Validation for SharePoint, LiveLInk, Qumas, FirstDoc, etc
- Enterprise Resource Planning (ERP) Validation for SAP, Oracle EBS, JDE, Microsoft Dynamics, etc
- Infrastructure Qualification – Network, Virtual and Cloud Qualification
- Manufacturing Execution System (MES) Validation for Camstar, SAP, Siemens, etc
- Product Lifecycle Management (PLM) Validation for Oracle Agile and Teamcenter
- Quality Management System (QMS) Validation for EtQ, Pilgrim and TrackWise
Manufacturing – Equipment and Automation
- Programmable Logic Controller (PLC) Validation
- Distributed Control System (DCS) Validation
- Building Automation System (BAS) Validation
- Heating Ventilation Air Conditioning (HVAC) Validation
- Supervisory Control and DATA Acquisition (SCADA) Validation
- Manufacturing Equipment Qualification
- Cleaning Validation