Our standard operating procedures and documentation are all designed in accordance with GAMP guidelines to better align with our customers quality requirements and company values.
#GAMP 5 GUIDELINES FOR DOCUMENTATION VERIFICATION#
We have a long experience and understanding of industry standards and guidelines. We will audit your available documentation and bring it in line with GAMP 5 A Risk-Based Approach to Compliant GxP Computerized Systems and Annex 11 of the GMP. Compliance training on software verification and validation training, documentation to meet regulatory / cGMP expectations, reducing the risk of FDA Form.
Zenith Technologies is your ideal partner in delivering projects which are compliant and to the highest standards of engineering excellence. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final PQ and OQ functionality testing. Step 1: Develop a User Requirements Specification (URS) Document The first step in selecting an adequate CMS is to determine your needs by developing a User Requirements Specification document. This document was designed to be used as a live document up until the DQ is completed and approved. (I.E.: classified according to GAMP 4 and/or 5), and each involves different levels of effort. These guidelines provide a reliable model to ensure that pharmaceutical companies remain GMP compliant while delivering the highest quality products to the end customer. User Requirements Specification (Issue 8) - 115.00. Good Automated Manufacturing Practice (GAMP) guidelines set by the International Society for Pharmaceutical Engineering (ISPE) cover all aspects of production from raw materials through to training and hygiene of staff. Manage your entire Project Life Cycle in accordance with GAMP Guidelines and GMP to respond to regulatory requirements
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