INSIGHT REPORT
Vol 4  #5
May
2001

INSIGHT REPORT

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Software is the next area of concern. 

The FDA requires that all equipment using software must have the software validated. The equipment specification should address the computer program used as part of the equipment operations. Not only is this a requirement in the GMP and QSR but it just makes for good business practices. It is essential that the equipment specification, at the very least, defines and describes the functional requirements of all-programmable computer systems and software associated with the equipment. The equipment specification must specify the make, model and the version level of the installed software, PLC, or any other programmable system. Additionally, the specifications should describe the computer requirements concisely and specifically. Examples include but should not be limited to: 

• Process Parameters 
• Operating sequences 
• Operator Interfaces 
• Alarms 
• Security 
• Parameter or Data Retention after loss of electrical power 
• 21 CFR Part 11 compliance (discussed later) 
• Environmental compatibility and Enclosure specs. 
• Utility Requirements (including cooling) 
• Calibration 
• Maintenance, contracted or otherwise 
• Backup requirements 
• Ladder logic or code printouts 
• any computer program security 
• data archiving requirements 
• loss of power requirements

The above list is a good start as far as the computer equipment specification is concerned. The equipment specification should specify the requirements before the equipment is even purchased. Once the equipment specification is complete then IQ/OQ work has already begun and all that is required is a simple testing of the output of the design versus the input. With an equipment specification, a baseline for subsequent validation is complete. It both provides and documents the critical functional requirements of the system.

Another area involving software is 21CFR Part 11., electronic records. It would be a very good idea to state that the equipment must be compliant with this section of the ACT.

Specifically, if records and reports are being stored electronically Part 11 compliance must be addressed. Make certain that all stored records be archived and password protected to prevent unauthorized access. Also the equipment specification should verify that any files or even programs themselves couldn't be altered or deleted. If the program runs in a Windows environment the equipment specification must require the installation of security measures. Also, if electronic signatures are utilized, verify compliance. Additionally keep in mind while designing the computer system, that all records and results must be audited regularly and the results attached to the permanent record.

It would make good sense to have equipment tested at the factory and be completely debugged before it is shipped to your facility for installation. Sometimes this is impossible if the computer system must work with a machine. However Factory Acceptance Testing verifying conformance to the requirements stated in the equipment specification should be included. The equipment specification should require that a certificate stating that activity was completed must be shipped with the equipment.

Computer systems are critical to business and they must be validated. But validation activities can be easier and more efficient with documented functional requirements. The equipment specification contains these and other items that describe the system in the company's setting in a way that manufacturer documentation can't. With computer system equipment specifications a baseline for efficient design and subsequent validation is complete.

Lastly, electrical schematics and ladder logic diagrams should be required. These and all other documents will be used in the subsequent computer validation protocol.

The equipment specification is not only a welcome document for any plant but, if it is completed correctly, a must for any operation to have. It provides the structure and defines all the requirements for the equipment and supplies a base line to be used as the driving force for all subsequent activities, including validation.

It is used in addition to SOPs, IQ/OQ, Validation Master Plan, Drawings, etc... It provides documented evidence that every piece of equipment from a hot plate to a reaction vessel has been properly designed and every aspect of it's function been considered before installation. A plant without an active library of equipment specifications would have a very hard time in assuring continued compliance - as well as waste a lot of time when they have to replace the equipment.

If you don't already have your equipment specifications prepared for each piece of equipment, it could be considered a very good investment to have such a document put together and kept along with your other quality documents. As was explained, it could be better and more valuable than an insurance policy when it comes to your day to day operations.

If you want more information on equipment specifications or Process Validation email mdi and reference this Insight report.

Next Insight – To be announced

If you have any comments on these INSIGHTS we hope that you let us hear them. If you have any of your own INSIGHTS that you feel would be of value to other companies, we would be pleased to hear from you and to discuss them with you and if you allow, we would even put them up on this site for others to learn from.
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