Pharmaceutical and Medical Devices

EMS Ltd provide a range of skills covering Feasibility studies, Project Management, Engineering and Manufacturing knowledge that facilitates the specification, procurement and installation of specialized machines and devices requiring validation and compliance to international recognised standards.

Typical Services Provided:-

• Project Management.

• Validation Plans.

• Validation Gap Analysis.

• Design Qualification
                            User Requirement Specifications.
                            Functional Design Specifications.
                            Design Specifications (Equipment, Hardware, Software).
                            Risk Assessments.

• System / Machine Testing
                            Factory Acceptance Testing and Site Acceptance Testing.

• Engineering Studies.

• Audit and Reviews
                            Vendor Assessments.
                            Supplier Reviews (Build / Construct phase).
                            Design Reviews.
                            Software Code Reviews to GAMP.
                            Post Project Completion Audits.

• Installation and Testing
                            Validation Protocols and Reports.
                            Installation and Operational Qualifications.
                            Performance Qualifications.

• Operation & Maintenance
                            Operating & Maintenance Procedure's, Calibration Procedures.
                            Equipment and Systems Requiring Periodic Review.

• Training Development
                            Training Plans.
                            Training Development of Personnel with Subject Matter Experts.

• Decommissioning of Equipment and Systems.

Our method of working is very much with the client we have found over the years that the success of the project is reliant on the client maintaining ownership and input through the entire process, with key individuals from the clients business included as part of the project team from the start.