Performance PharmaTech Limited provide technical support to the pharmaceutical industry and its equipment suppliers. Our principle skills are in the validation of computer based pharmaceutical packaging equipment.
Our support begins with a group of highly qualified and experienced consultants. We staff projects based on required expertise and scope, providing the most efficient and cost effective Computer System Validation services possible.
We are highly involved in the implementation of serialization schemes for pharmaceutical Track & Trace and have worked with many manufacturers and equipment suppliers in throughout Europe, as well as North and South America.
We are centrally located in Peterborough, and our consultants travel worldwide to offer experienced personalised services to a broad spectrum of clients.
With our highly experienced team, Performance PharmaTech provide cost effective customised documentation sets, such as Quality Plans, Project Plans, Functional Design Specifications, Installation and Operational Qualifications, Risk Assessments and Traceability Matrixes. We can create suitable validation and other regulatory support documentation in accordance with the pharmaceutical industry's unique and evolving requirements.
We spend considerable time and effort keeping up with the latest trends in legislation, like Annex 11 of the European GMP, Section 211.68 of the US cGMP regulations directive and understanding the latest, country specific, serialisation guidelines. We can help you exercise appropriate documentary controls over computer or related systems in a pragmatic and cost-effective manner.