Equipment qualification or validation as required by the FDA and other regulatory body requires verification documentation to start with the Validation Master Plan (VMP) and flow through a series of documents that define the scope and tasks required to successfully execute your equipment validation task. The VMP dictates the actions that all persons involved in equipment validation projects must comply with. The Equipment Validation Plan (VP) may often be designed to include more than one piece of equipment. The list of equipment will be appended to the plan. Each of these items will have its own stream of documentation; typically,
VP - URS - DQ - VRA - IQ - OQ -PQ
All regulatory required FDA Compliant documentation must be carefully prepared, with statements worded to preclude ambiguous and incorrect interpretations of the purpose of the statement. In addition there are quite separate requirements stipulated by the regulatory authorities. Documents presented to regulators during inspections that fail to satisfy these requirements, indicate to the regulator a lack of care and commitment on the part of the company. The exact opposite to what is required.
To overcome these problems we are introduced first time in pharmaceutical industry with complete set of documentation for equipment qualification activity. We offer following documents which are essential for equipment qualification program.
The release of GAMP 5 aims to provide guidance on regulatory compliance through cost and time effective methods and signifies a period of transition of new ideas with a more innovative approach to compliant systems.
CSV Documentation may include :
Risk assessment protocols and reports
User Requirement Specification (URS)
Design Qualification / Design Specification
Installation qualification protocols and reports
Operational Qualification protocols and reports
Performance Qualification Protocols And Reports
Standard Operating Procedures (Sops)
FAT And SAT Protocols
MediVal Technologies delivers leading Compliance and Computer System Validation services that are designed to help reduce the overall cost of compliance for Pharmaceutical and Life Sciences organizations. We offer our clients cost-effective and comprehensive compliance and validation services.
We provide validation services for automated manufacturing practices used in pharmaceutical industries. We have good expertise in validation documentation and validation execution. We use a Risk based approach of GAMP 5 for validation.
If you have any specific questions about us or any of our services, get incontact with us.