Our Approach to 21 CFR Part 11 & Annex 11

MCP has detailed expertise in all aspects of Data Integrity. The current push by the US and European Authorities to allign data management into a coherant standard is causing a major push to assess and implement solutions. With our expertise, we can drive proper assessment, recommendations, implementation and periodic management support of implemented solutions.

Stage 1: Assessment based on FMEA ISO using Part/Annex 11 & GAMP Parameters.

Initial Systems Assessment based on FMEA ISO Model in conjunction with EU & US Regulations. The assessments are designed on a joint CFR Part 11 and Annex 11 approach and are designed to indentify regulatory complinace or non compliance. We have a custom designed assessment tool for the determination of systems compliance.

Stage 2: Software & Process Mapping of Systems

Software and process mapping of each assessed systems is carried out to detail the full interaction between the software, process and human interaction. This is then matched with the previous stage assessment to determine linkages of criticality between the risks identified with impact on the process/product. The mapping also allows for the identification of potential improvements for complinace as part of the next stage. Stage 3: Development & Execution of Post FMEA Mapping Project Plan.

Stage 3: Development & Execution of Post FMEA Mapping Project Plan

The definition and set up of a project charter & plan for the implementation of compliance measures, systems updates and GxP procedural corrections. Implementation of above plan based on project charter, scope and deliverables dealing with SOPS, systems work instructions, system functions including updates/replacement of software and hardware - leading to a defined compliant system which has been mapped and qualified for use.

Final Stage: Certification

Upon completion of the GxP update, systems upgrade and confirmed compliance, a final protocol certification is signed off by our organisation in line with final documented Part 11/Annex 11 qualification

Let us support your GxP Demands

Please feel free to contact us for a consultation. We would be glad to help you out regarding any data intregity query that you may have.



DI: Projects Completed


DI: Systems Assessed/Updated Per Project


DI: SOPs Assessed/Updated Per Project


Regulatory Deadlines Achieved