Commissioning and qualification planning -
Develops planning documents and progress monitoring tools.
Overall planning documents outlining strategies and procedures to be followed assuring the commissioning and qualification program delivers equipment systems and processes that are fit for their intended purpose and comply with cGMPs and regulatory requirements.
Estimating and scheduling -
Develops the commissioning and qualification schedule and estimates resource needs.
A supporting activity working along side the project controls team assuring commissioning and qualification activities are built into the project schedule and resource costs together with associated test equipment/consumables are included within the project budget.
User requirement specifications -
Manages the workflow and assists in document development.
Foundation documents which embrace business drivers and process needs, including critical quality attributes and critical process parameters, key functionality requirements and product contact materials of construction.
Project change management -
Manages the workflow requests and assist initiate/close project change requests.
A communication tool and workflow process whereby project desires are considered for implementation, action items defined and documentation closed out in order to maintain project integrity.
cGMP design reviews and design qualification -
Manages the workflow, develops documentation and drives closure of action items.
A cGMP workflow process and documented verification that the proposed design of the facilities, equipment or systems is suitable for the intended purpose.
System boundary definition -
Manages workflow, documents system boundaries and maintains the project system list.
A workflow process by which systems to be installed are delineated into discrete entities aligning with natural vendor supplied equipment items together with commissioning, qualification execution and turnover requirements.
System and component criticality assessments -
Manages the workflow and prepares documentation.
A risk based approach to assessing the cGMP criticality of systems and components within those systems - direct impact, no impact and indirect impact.
Equipment/automation service provider procurement -
Ensures commissioning and qualification needs are incorporated into contract documentation.
An activity to ensure provided services, testing and documentation aligns with the needs of the commissioning and qualification program.
Construction and vendor quality control plans -
Ensures service provider quality documents are in place and appropriate to support the commissioning and qualification program.
Proposal documents detailing how the service provider or vendor will deliver their service including manufacturing procedures used, testing to be performed and documentation to be provided.