Qualifying Network Infrastructure - A Risk-Based Approach - - BioPharm International

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Qualifying Network Infrastructure - A Risk-Based Approach


BioPharm International


Tools for Network Qualification As clients, servers, and instruments are connected to a network, the available bandwidth may become dramatically reduced. This is especially true if the network is not well segregated, leading to unnecessary broadcast network traffic (for example, between an analytical laboratory network and the office network). This decrease in bandwidth may result in decreased performance affecting real time processes (and could even result in data loss as the hospital network example cited above shows).

Modern analytical equipment and the networks within which they operate may be monitored by network analyzer software along with the clients and servers that control them. This software not only helps operators monitor the health of their networks but also aids in the qualification of the networks through which the instrument data flows. Network monitoring applications are commercially available from companies including Agilent Technologies, Computer Associates, Hewlett-Packard, IBM, and others. While software applications provide excellent monitoring capabilities, network qualification may also require powerful network measurement and test hardware to capture and document network connections, communication activities, available and consumed capacity, and control data. For regulated lab operations, the challenge is to make network measurements meaningful from a systems validation perspective. In the meantime, the first examples of metrology-based network assessment and qualification services designed specifically for laboratory networks have been developed.11

Validation and qualification activities need to consider network infrastructure. The role of network monitoring hardware and software for the qualification of networks and for maintaining the qualification status of the network infrastructure will continue to increase.

The authors thank Bob Giuffre, a senior network data system consultant with Agilent Technologies based in New Jersey, for input to this manuscript and sharing analysis data derived from network monitoring measurements using the Agilent Advisor/Distributed Network Analyzer and Agilent FrameScope 350 in combination with an Agilent Cerity for Pharmaceutical QA/QC networked data system and Agilent 1100 HPLC instruments directly connected to the local area network.

References 1. FDA. Pharmaceutical cGMPs for the 21st century: a risk-based approach. Available at URL: www.fda.gov/oc/guidance/gmp.html.

2. ISPE. The good automated manufacturing practices (GAMP) guide for validation of automated systems in pharmaceutical manufacture, GAMP 4. Tampa: ISPE, 2001.

3. Huber L. Risk management master plan and best practices series. Available at URL: www.labcompliance.com.

4. ISPE. Risk-based approach to 21 CFR Part 11. Available from URL: www.21cfrpart11.com/pages/library/index.htm.

5. Code of Federal Regulations, Title 21, Part 11; electronic records; electronic signatures; final rule. Federal Register 1997; 62(54):13429-13466.

6. FDA. Guidance for industry: Part 11, electronic records; electronic signatures and scope and application. (draft February 2003, final version August 2003). Available at URL: www.fda.gov/cder/guidance/5667fnl.pdf.

7. FDA. Warning letter. File No. 320-01-08. Available at URL: www.fda.gov.

8. Associated Press. L.A. hospital computer system breaks down. 22 Apr 2003.

9. Fiorito T, Quinn T. Qualifying peer-served network infrastructures. Presented at the 37th Drug Information Association Annual Meeting, 2001 Jul 8-12; Denver, Co. Available at URL: www.hollisgroup.com/downloads/DIA%20-%20C3Q%2001.pdf.

10. Huber L. Validation of computerized analytical and networked systems. Boca Raton (FL): Interpharm Press; 2002.

11.Agilent Technologies. Qualification services for laboratory networks. Agilent publication 5988-9656EN. Palo Alto (CA): Agilent, 2003.


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