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Validation Protocol - SOP

It has always been known that facilities and processes involved in pharmaceutical production impact significantly on the quality of the products. The processes include raw material and equipment inspections as well as in-process controls. Process controls are mandatory in good manufacturing practice (GMP). The purpose of Validation Protocol is to monitor the on-line and off-line performance of the manufacturing process, and hence, validate it. Thus validation is an integral part of quality assurance.

Validation protocol in eresource ERP allows constructing the method of SOP for any product manufacturing. The over all protocol standards are shown in the SOP' for the different protocols, here we are concerned about the testing element alone. All testing must be detailed and pre-approved by a qualified person to ensure the system under test has been adequately tested. Each test must comprise of data element as shown in the screenshot.

Further, the SOP Management screen in eresource enables to record all process related documents, including validation of audit reports, including all standard operating procedures (SOPs), and change control procedures.