Software Validation Protocol Template. Download a free validation protocol template in pdf format or buy a full document version in MS Word format from the following list. Feel free to share this information with your contacts.
Requests that a controlled process is instigated or an existing controlled process requires a serious modification miner modification would be controlled under change control a User Requirement Specification URS document is raised. Protocol authors should never be allowed to commence construction of validation template protocols without being made aware of the company constraints definitions scopes methodology and individual responsibilities as authorized by the company. REFERENCED DOCUMENTS Reference to specific documents should be made to support the validation study.
Here is a sample FDA software validation template.
Risk Analysis the GAMP standard template is recommended. Outlines the scope of the validation project and the strategy for validating the softwares installation and use. An operational qualification template is used to complete the process validation protocol by recording all required data such as calibration equipment training records and users manuals and indicating the results from control points alarms and outputs. Requests that a controlled process is instigated or an existing controlled process requires a serious modification miner modification would be controlled under change control a User Requirement Specification URS document is raised.