This activity is multifaceted activity, and includes several supports that might be provided to the client. Below an excerpt of support activities that ECO INTERNATIONAL can provide:
The purpose of the Validation Master Plan (VMP) is to provide an overall strategy for qualification and validation efforts, describing test activities and studies that will be carried out to demonstrate that utilities and equipment have been properly built and installed and are able to work in a reliably and repeatedly manner, according to pre-established requirements and quality.
The RA and assessment is a technique to determine which systems and/or system components/functions should be subject to Qualification Practices in addition to Good Engineering Practices (GEP) and which systems should be only commissioned in accordance with GEP.
ECO can write and execute Design (DQ), Installation (IQ), Operational (OQ), Performance Qualification (PQ) protocols, as well as Process Validation Protocols. This activity is applicable to all production forms and branches.
ECO can support the client with Computerized Systems Validation for all GAMP levels, and also providing support for 21 cfr. part 11 compliance verification, Data Integrity, serialization, etc.
The presence of personnel experienced in engineering and dedicated to validation let ECO execute GMP review of existing sites, sites under design or under construction. The purpose of this activity is to identify, trough procedures, and comparing with norms and guideline, if a plant is installed, being installed or designed accordingly GMP.
ECO can provide also QA support, including: process validation, cleaning validation, validation efforts optimization, SOP writing, QA and QC SOP review, etc.
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