Validation of Automated Control Systems

IEH inc., Laboratories & Consulting Group staff can develop validation procedures for automated control systems used in pharmaceutical or food manufacturing. IEH will utilize either the NFPA Bulletin 43-L or the GAMP 4 Guidelines for this important process that will cover life-cycle definition and planning, system design, system qualification, system operation and on-going verification, system security, and documentation.

For life-cycle planning, IEH staff can assist manufacturers with system definition by determining critical requirements and development of a Validation Plan for the automated system. IEH can help develop a Traceability Matrix that describes the relationships between the various phases of the life-cycle process and a Responsibility Matrix that defines the responsibilities of various members of the validation team during the life-cycle process.

Three important specifications should always be put together for design of an automated control system, and IEH staff can assist manufacturers develop the User Requirement Specification (URS) that describes what the automated control system is supposed to do. Usually the equipment supplier will then put together a Functional Specification (FS) that will describe what the automated control system will do, and IEH can work with food or pharmaceutical manufactures and the equipment suppliers to make sure the FS properly addresses description of the control system hardware and software. IEH recommends that manufacturers and equipment suppliers have in place a software/system management structure that follows an ISO/IEC 12207 or a Capability Maturity Model (CMM?) approach for automated system design, and IEH staff will work with manufacturers to ensure that the Design Specification (DS) is a complete detailed definition of the automated control system to allow it to be properly built, tested, maintained and operated.

System Qualification is the part of automated system validation that tests and challenges the system to verify that the system meets the requirements of the URS, FS and DS. IEH can work with manufacturers and suppliers during the Installation Qualification (IQ) phase of system validation to determine if the automated system meets all the requirements outlined in the DS. The Operational Qualification (OQ) phase confirms that the automated control system operates properly during normal operating and abnormal conditions that could occur that have been defined in the FS, and IEH staff can work with the manufacturer and equipment supplier to determine if the hardware and software of the automated system meet FS requirements. Also, IEH can assist the manufacturer with the Performance Qualification (PQ) phase that confirms that the automated control system performs for the manufacturer as defined in the URS, and PQ should be conducted with properly trained facility personnel during normal manufacturing operations.

Change control, preventative maintenance, and record review programs are important to ensure that the automated control system operates properly throughout its useful life. IEH can assist manufacturers with development of these programs that can be very important during regulatory inspections of automated systems that may also produce electronic records.
IEH can also help manufacturers establish automated control system security provisions. Manufactures should make sure that hardware, software, and record security procedures are in place for the automated control system.

Furthermore, IEH staff can assist manufactures with development of proper validation documentation for automated control systems, and this documentation should be in place before the pharmaceutical or food manufacturer uses the automated system for commercial production. One important document that IEH can help manufacturers develop is the Validation Report that will be completed after the IQ, OQ and PQ have been completed.

Finally, many manufacturers have legacy automated systems in operation that have not been properly validated, and IEH can determine the minimum proper steps that a manufacturer should complete to ensure that these older but time-tested systems are properly validated for safe operation under normal and abnormal production conditions.