Subject Matter Experts

Subject Matter Experts are being referred to in many new standards and guidance documents and also in current regulatory inspections. ASTM 2500 is particularly descriptive in the requirements for SME’s and also Good Engineering Practice generally.

“where did you get your Subject Matter Expertise from…….”

“who is your Subject Matter Expert in this area……”

The SME role adds a lot of value, particularly at the beginning of a new project. EPIC can provide this Subject Matter Expertise to work with your team at any stage in the project or in Process Improvement projects in the future.

EPIC can be engaged for a specific project or retained to provide SME services on an on-going basis. Such clients will gain access to a download area which is being populated with a number of useful guides, reference documents, model protocols, audit proforma’s etc.

EPIC, through a network of SME’s can provide the following:-

• SME in Bioburden Control and Sterilisation Processes
• SME in Sterile Product Manufacture
• SME in Clean Rooms
• SME In Water and Steam
• SME in Critical Utilities
• SME in Software Validation and Data Integrity
• SME in Engineering Systems
• SME in Calibration Systems

For more information on any of the above, or to discuss your requirements and offer the SME for your application please contact us