Validation Department

Validation Overview
Validation is applied to many aspects of pharmaceutical manufacturing, including instrumentation, HVAC systems etc. In each case the objective is to produce “documented evidence, which provides a high degree of assurance that all parts of a facility will consistently work correctly when brought on-line”. Traditionally, validation has consisted of the following:

Design Qualification (DQ) - Documented evidence that the design of the system meets requirements
Installation Qualification (IQ) - System has been installed correctly
Operational Qualification (OQ) - System operates according to design
Performance Qualification (PQ) - System meets design criteria, and operates according to requirement

Traditionally, each of the ‘Qualification’ sections has contained both the specification and the test protocols aimed at verifying that each stage is completed. The term Validation Protocol is often used when referring to these documents.

SCS Provide Documents which simplify the overall validation process. Many of the tests performed by SCS meet (or exceed) the site requirements for IQ and OQ, and often become reference documents for the User to direct a testing matrix toward.

System Documentation
The document which initiates the validation process is the User Requirement Specification (URS). This describes the equipment or system as it is supposed to work and is normally written by the system user. The original version issued for quotation should normally contain the essential requirements (musts) and the desirable requirements (wants). The final version then accommodates all the musts, which can be met, and any of the wants, which also can be satisfied. The URS is now a standard document required for companies to meet the ISO9001: 2000 standards.

The Function Design Specification (FDS or FS) is written by SCS and describes the functions of the equipment or system. The FDS links to the OQ as each major parameter stated should be tested. The FDS is also a standard output document required by ISO 9001: 2000.

The Hardware Design Specification (HDS) is written by SCS and describes system architecture and hardware design requirements.

The Software Design Specification (SDS) is written by SCS and describes all data, architectural, interface and component-level design for the software.

The documentation then includes the system build and testing of the installed components. These documents are the testing qualifications IQ, OQ and PQ. At given stages during the lifecycle of the project, planned and systematic reviews should be performed. The design reviews evaluates the deliverables against standards and requirements.

Benefits of Validation
Validation is the formal documentation of good system development practices. The principal benefit of validating a system is Compliance. The information gathered before, during and after validation leads to improved and confirmed compliance as changes are introduced. Other benefits are:
• Systems which are well defined and specified, easier to maintain, resulting in less downtime
• The system delivered is fit for purpose, on time, within budget
• Satisfy the User Requirements
• In-depth understanding of the process
• Improved operational efficiency in a shorter time frame
• Reduced risk of failure
• Maintenance of quality standards
• Operators understanding the systems, leading to improved communications between departments

Maintaining the Validated State
When a system is validated and in operation, measures should be taken to ensure that the system remains in a validated state. This maintenance not only involves the integrity of the hardware and software, but also the documentation. The maintenance of a validated system includes many activities, which the User is responsible for.

System Operational Procedures (SOPs)
SOPs should be established to define the use and support of the automated system. SOPs should be approved prior to use.

Training
Training plans should be established for use and support of the system. These plans need to consider the training of all users, technical and support.

 

Validation Engineers

As a Validation Engineer for Standard Control Systems Paul Ryan produces documented evidence of the Validated Building Management System which includes the Functional specification (FS), Hardware Design Specification (HDS) & Software Design Specification (SDS) and the Installation Qualification Test (IQ) & Operation Qualification Test (OQ) which meet (or exceed) the requirement of the User Requirement Specification (URS) and compliant with FDA 21 CFR part 11.

Paul defines the Validated Building Management System which leads to easier maintenance, resulting in less downtime
E nsures the Validated Building Management System delivered is fit for purpose, on time, within budget
Oversees the design of the Graphical User Interface (GUI)
P rovides in-depth training to the end user on the Graphical User Interface

Paul has been involved with implementing a Validated Building Management Systems on the following pharmaceutical companies:
Allergan Pharmaceuticals (Ireland) Ltd
Servier (Ireland) Industries Ltd
Wyeth Medica Ireland

You can contact us at Info@Standardcontrol.ie

Tel:01 4291800