ISOPOD DELIVERABLES

Commissioning & Verification

Commissioning & Qualification of systems ensures reliable operation and regulatory compliance of facility and equipment, to ensure product end quality and traceability.

We design with C&Q in mind and we ensure integration is integral to turn key success, we risk assess at commissioning stage and address the critical path items up front.

Documentation

We develop and execute the following qualification documentation depending on client project requirements.

⦁ User Requirements
⦁ Function Design Requirements
⦁ Design Qualification
⦁ Hardware Requirements/Software Requirements
⦁ P&ID Requirements
⦁ Project Commissioning and Verifications plans
⦁ Commissioning and Verifications Protocols
⦁ Validation Plans and Protocols (in line with Client site VMP)
⦁ Factory Acceptance Tests (FAT)
⦁ Site Acceptance Tests (SAT)
⦁ Installation and Verifications protocols
⦁ Performance Verifications

Qualifications

We provide a combination of the above documentation to cater for the client’s project needs or we can execute the clients protocols depending on the clients requirements.
Our activities are guided by standards such as ISO 14644 and ASTM-E2500, 21 CFR part 11 and CSV guidelines.
We also provide guidance and assistance on:
⦁ Process & Equipment Validation
⦁ Sampling Locations maps
⦁ Risk Analysis
⦁ Cleanroom Monitoring, Class and Limits

PROCUREMENT

The efficient expediting of materials and equipment orders is a key element of every project.
Cost control and schedule management very much depend on efficiency in procurement.
Project procurement management is the creation of relationships with outside vendors and suppliers for goods and services needed to complete a project. This process is comprised of five steps:

Initiating and planning
Selecting
Contract writing
Monitoring
Closing and completing

ISOPOD have developed relationships with a large number of specialist suppliers and vendors providing us with the opportunity to ensure value and quality.

With every project a strategy is developed and actively managed. The strategy details the approach to be adopted from order placement to order completion.

Whether entrusted with the entire process or limited only to receipt of goods and services we deal with procurement with the objective of delivering for the project a timely and efficient process.