on time and on budget
Areas of Services
VALIDATION
- Computer System Validation (CSV)
- Packaging Validation
- Cleaning Validation
- Equipment Qualification
- Utilities & Facilities Qualification
- Process & Product Validation
- Change Control Documentation
- Work Instruction
- NC’s CAPA’s, NOC, Investigations, etc.
- Standard Operating Procedures (SOP’s)
- Network Qualification / Infrastructure
VALIDATION GAMP 5 SDLC DELIVERABLES
- Validation Plan
- User Requirements Specifications
- System Design Specifications
- Technical Specifications
- Validation Protocols
- Traceability Matrix
- Reports
- Risk Assessments
- 21 CFR Part 11 Assessments
- Data Integrity Assessments
AUTOMATION / MANUFACTURING
- Automation & Control Systems
- Serialization Support
- PLC Programming and Troubleshooting
- I/O Ladder Logic and Source Code Verification
- Project Management
- Project Engineering
- Vision Systems Support
QA & Regulatory Services
- IQ/OQ/PQ Protocols Development and Execution
- Equipment, Utilities & Facilities Qualification
- Commissioning
- Pre-approval inspection readiness
TECHNICAL
- Strategies Development
- Engineering Studies
- Technical Transfer
- Process Development
- Packaging Studies
- Packaging Development
- Process & Packaging Validation
Process Design
Process Qualification
Continous Process Verification
IT
mîrus has a group of professional employees dedicated to fulfill and find the best solutions on IT products. Using the latest technology, our employees are insured to provide a highly sophisticated network design, secure and cutting edge.
We use the most modern programs and equipment to fulfill customers’ needs. Renowned brands such as, but not limited to, Hewlett Packard, Microsoft and Lenovo, are part of our options when choosing the best server, workstation or software for our clients. Our customers can choose from a variety of laptops and desktops computers type, depending on the particular needs of the business.
- Regulatory Compliance Assessments
- Project Managers
- Information Systems Implementation and Qualification
- Networks (WAN, LAN, WLAN)
- Security Systems
- System Engineering
- Data Centers/Computer Rooms
- Servers and Workstations
- Network Infrastructure Assessments, Design,
- Implementation and Remediation
- Information and Control Systems Configuration and Integration
- Information Security Assessments and Recommendation Plans
- Disaster Recovery and Business Continuity Planning
- Network Engineering
ENGINEERING SERVICES
We rely on our talented and experienced professionals that utilize a common sense approach combined with tools, such as MS Project®, to optimize project efficiency and cost control while maintaining high quality standards to achieve our customers' goals.
Our Project Managers/Engineers, Construction Managers & Consultants have broad exposure to projects in international markets and industries:
➤ Regulatory Compliance Assessments
➤ Information Technology
➤ PMP certified
➤ Validation
➤ Pharmaceutical, Bio-Tech and Medical Devices
➤Construction Management
Engineering - Facilities and Utilities Commissioning
- Facilities
- Layout
- CAD Technicians
- Alarm Systems
- Security Systems
- Utilities Functionality Verification
- Compressed Air
- Potable Water
- Electrical
- Dust Collector
- Air Handling Units