Global Capabilities for Regulatory Standards
Invensys Validation Technologies is the most experienced company with the critical mass to staff a global ERP practice. This reduces costs, reduces validation times, and ensures a consistent approach that is particularly appealing to multinational pharmaceutical companies. Our team of experts works with you to understand your key business objectives as well as your quality standards, making sure that your business is compliant and up to date with global regulations.
Invensys Validation Technologies has successfully completed many validation projects with major pharmaceutical companies on ERP systems from SAP, J D Edwards, Oracle, Marcam, Promix, BPCS, custom systems such as proprietary in-house developed systems as well as others.
Key Customer Benefits
Some of the benefits of working with our experienced consultants include:
- Access to a large staff of experienced ERP and regulatory consultants
- Highly trained and qualified ERP and regulatory consultants
- Global ERP validation methodology standard
- Lower overall project costs using our skilled ERP validation experts
- 21 CFR Part 11 compliance (link to section 21 CFR Part 11 5.5.5)
- Integrated methodology that reduces risk and increases efficiencies
- Validation methodology that aligns with ERP implementation methodology
- Validation integrated with business process and project implementation steps
Invensys' global ERP practice has highly experienced, knowledgeable ERP validation consultants based locally in principal pharmaceutical processing regions around the world. Our ERP validation consultants utilize our well-proven ERP project management and validation methodology to ensure consistent implementation practices at regulated facilities anywhere in the world.
ERP Validation Services
Specific ERP validation consulting services offered by Invensys' new global practice include:
- Full ERP System Life cycle validation Implementation/upgrade and enhancement project management
- System Risk Assessments
- 21CFR Part 11 compliance services
- Increased ERP ROI and process optimization consulting services
- IS/IT validation infrastructure assessments and validation support
- Quality assurance system reviews and audits
- Design qualification
- System "go-live" protocols
- Business continuity planning
- ERP data warehousing validation
- ERP data archiving validation
- ERP change control and maintenance procedures
- Revalidation of ERP systems
- ERP Validation
Our business systems validation methodology based on GAMP principles integrates the business processes with the validation process.
Other types of IT / Business systems that Invensys has experience with includes:
- Business information management systems (IT)
- Enterprise resource planning systems (ERP)
- Materials requirements planning systems (MRP)
- Manufacturing resource planning systems (MRPII)
- Customer relationship management systems (CRM)
- Clinical trial management systems (CTM)
- Document management systems (DMS)
- Supply chain management systems
- Production management systems
- Network systems
Our risk-based approach is a systematic and well-documented methodology for ERP systems based on our vast experience.
