In an era of uncertain policy and regulatory environments, it is increasingly difficult for life sciences manufacturers to navigate the complex compliance landscape. PCI’s consultants provide decades of experience and industry-leading knowledge, coupled with the latest quality by design and management techniques to improve your business’s compliance and efficiency.
- Engineering data strategies
- Project management and CMMS implementation services
Let us develop a program that optimizes your company’s lifecycle asset management and that improves and ensures the quality and compliance of your calibration and maintenance operations.
Engineering Data Strategies (Project and Operational-Based)
Building a data strategy from facility or process inception is the key to ongoing success for data integrity and critical data transfer. PCI Consultants have extensive experience building data strategies for critical systems and projects, including commissioning activities, start-up and calibration support, regulatory and impact/boundary assessments, site acceptance criticality, and client CMMS and platform alignment.
Achieving and maintaining compliance is the bedrock of PCI’s consulting program. For more than 20 years we have provided industry-leading guidance, implementation, and outsourced program solutions for our clients.
Program solutions examples:
- Change management
- Criticality, frequency, impact and tolerance assessments
- Policy and procedure development
- Program effectiveness assessments and gap analysis
- Support of commissioning & qualification system boundary development
- Strategy development for critical equipment
PCI’s highly-skilled experts also support remediation projects and regional/global continuous improvement projects.
Project Management and CMMS Implementation Services
Whether you have a technology platform, a start-up and greenfield opportunity or a remediation and compliance project, PCI’s consulting experts can provide you with the skilled support you need for a successful project.
- Full implementation management
- IT support
- Configuration support
- Data migration
- Data engineering and modeling
- CSV-IQ/OQ/PQ services
- Custom report writing
CMMS Implementation Services
- Blue Mountain
- Infor EAM
- Datastream legacy support
- Calman legacy support