Blog Post by Group Engineering Manager Virginia M. Bergman
At Superior Controls, we understand high standards for documentation are paramount for our customers. Due to the joined effort between the Project Manager/Project Engineers and the Validation/Project Engineering Group, our documentation has been commended by our customers. As a result of the level of testing provided, several customers have leveraged our factory and site test protocols during their validation effort, yielding a cost savings for the customer.
Superior Controls follows The International Society for Pharmaceutical Engineering’s (ISPE) Good Automated Manufacturing Practice (GAMP) 5 as our guideline to develop the documentation associated with all projects. For manufacturing, GAMP 5 provides a pragmatic and practical guide to the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. At Superior Controls, a group of engineers, specifically chemical and electrical engineers, supports the documentation development efforts, working closely with the Project Team.
Typically, one engineer from the Validation/Project Engineering Group is assigned to any given project. The engineer is involved from the internal kickoff meeting to the closeout process of the project. During the internal kickoff meeting, the customer’s process requirements are identified. The documents are developed either by the Validation/Project Engineer or by the Project Manager and undergo a series of reviews between the author and the Validation/Project Engineer before submittal to the customer, to assure accuracy and comprehensiveness.
The Quality and Project Plan (QPP) is developed for qualified systems, and it defines how Superior Controls will fulfill the Customer’s quality requirements. It includes the activities to be performed and who will perform them, the project schedule, the control mechanisms to be used, and the deliverables.
Using the User Requirements Specification (URS) and/or the notes from the kickoff meeting, Superior Controls develops the design documents:
- Functional Specification (FS) and I/O List define the functions and instrumentation being monitored/controlled, and the operator interface design and all system I/O requirements.
- Hardware Design Specification (SDS) and the Software Design Specification (HDS) describe the control system hardware and software in detail.
Using the approved design documents, in parallel with controller and operator interface code development, Superior Controls develops the factory acceptance test protocols:
- Hardware Factory Acceptance Test (HFAT) defines the procedures and protocols that will be used to fully test, with the Customer, the control panels prior to shipment, and includes point-by-point I/O check sheets for verification of all I/O.
- Software Factory Acceptance Test (SFAT) defines the procedures and protocols that will be used to test and challenge, with the customer, the control system software prior to shipment. All individual control modules are tested as stand-alone components and also as part of the integrated control system.
Superior Controls then develops the Site Acceptance Test (SAT), which defines the procedures and protocols that will be used to test and challenge the control system after installation at the customer site.
Additional validation support is provided as required, and it may include a traceability matrix, and qualification protocols development and execution.
Superior Controls has passed 50 consecutive FDA-mandated audits in the past 20 years; many with large publicly traded biotech companies. We welcome the audits. By integrating advice from every new auditor, Superior Controls’ Quality Assurance System has grown to over 1000 pages of GAMP 5 compliant validation templates and procedures.