What is a risk based approach?

As discussed in a previous article (Changes in Validation) a risk based approach to computer systems validation has change the way validation is performed.

Spend LessMany in the pharmaceutical and biotech industries miss understood the message of a Risk Based Approach as an opportunity to take quality risk and spend less on the introduction of new equipment; that is to take a risk.

However this

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CSV FDA Warning Letters : Audit Trail

Date: 14 January 2010
Link: FDA Warning Letter (New Window)

Observation6. Your firm has not exercised appropriate controls over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)].

For example, your firm lacks systems to ensure that all electronic data generated in your

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CSV FDA Warning Letters : Operational Compliance

Date: 21 December 2009
Link: FDA Warning Letter (New Window)

Observation19. Automatic, mechanical, or electronic equipment is not routinely calibrated, inspected, or checked according to a written program designed to assure proper performance [21 CFR 211.68(a)]. For instance, the mixer, scales, filling/dispensing machine, water distiller, foil heat sealing machine, drying chamber, and tablet

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CSV FDA Warning Letters : Qualification

Date: 27 April 2009
Link: FDA Warning Letter (New Window)

Observation8. Failure to maintain a written record and appropriate validation data of computer or other automated processes used to perform calculations in connection with laboratory analysis [21 CFR 211.68(b)]. Refer to FDA 483, Observation 12. For example, the accuracy of calculations performed by the [(b)(4)] Spectrophotometer has not

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CSV FDA Warning Letters : Security

Date: 07 May 2009
Link: FDA Warning Letter (New Window)

Observation5. Your firm has not exercised appropriate controls over computer or related systems to assure that changes in control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)J. For example, one user account is established for two analysts to access the laboratory instrument's software on the

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CSV FDA Warning Letters : ERP and Calibration

Date: 07 May 2009
Link: FDA Warning Letter (New Window)

Observation4. Failure to routinely calibrate, inspect, or check according to a written program designed to assure proper performance of automatic, mechanical, or electronic equipment, including computers, used in the manufacture, processing, packing and holding of a drug product. [21 CFR 211.68]

Part A
A. The Enterprise Resource Planning

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CSV FDA Warning Letters : Qualification

Date: 08 April 2010
Link: FDA Warning Letter (New Window)

Observation7. Your firm failed to routinely calibrate, inspect, or check automatic, mechanical, or electronic equipment according to a written program designed to assure proper performance [21 C.F.R. § 211.68(a)].
For example, your firm has not conducted performance qualification for the (b)(4) unit-dose packaging machine (b)(4)™ to

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Computer System Impact / Risk Assessment

Purpose of Risk AssessmentThe purpose of the risk assessment process is to ensure that the validation (quality) effort is directed at the systems that have the potential to impact product quality, efficacy and data integrity (throughout this article referred to as Product Quality).
Initial Risk AssessmentsIn the ISPE Commissioning and Qualification Guide the approach to an initial impact

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FDA to Increase Inspections in 2010

The US Food and Drugs Administration (FDA) have been given a significant budget increase for 2010 as reported on Congresswoman Rosa DeLauro web site.


Introduced by Rep. Rosa DeLauro (D-CT), the bill (H.R. 2997) provides the amount that President Obama requested for the agency, which is roughly $373 million more than the FDA’s budget for fiscal 2009 (15% increase).

The funds will help the FDA

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MHRA Inspection Trends

Unlike the US Food and Drugs Administration (FDA) the Medicines and Healthcare products Regulatory Agency (MHRA) do not publish individual findings however they have published inspection trends.

The result of the trends shows that Computer Systems Validation has a number of Major Observations. Comments or observations from the trended data are welcome.

Link to MHRA Inspection Trends

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Efficient Software Testing

Testing, as with all validation activities, is not only performed to demonstrate regulatory compliance but to ensure that the system operates correctly.

The level of testing performed should be dependant on the complexity, maturity and criticality of the system.

A standard laboratory instrument should not need the same level of testing as a bespoke automated control system. This is where the

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ISPE GAMP5

GAMP 5 was released in 2008 detailing “Risk Based Approach to Compliant GxP Computerised Systems” with the tag line “Enabling Innovation” and was hailed as a major advancement in the industry.

This article provides a short review of the GAMP guide and the benefits to the industry.

ASTM StandardThe publishing of the ASTM Standard E2500-07 in June 2007 set the scene for

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GAMP5 Software Categories

As discussed in ISPE GAMP 5 the GAMP Categories for hardware and software have been retained in GAMP 5, all be it in a modified format from GAMP4.

The software categories identified in GAMP 5 do not fit with determining the risk to product quality, efficacy or data integrity and no longer plays an integral part to determining that a computer system is fit for purpose.

The complexity and the

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Changes in validation

There have been many changes to the approach to validation of equipment, including computerised systems over the last few years. This has culminated in the release of GAMP 5 in 2008.

The changes in approach started with the publication of the ICH Q9 (Quality Risk Management) in 2005 and adopted by the major agencies. This presented a risk based approach to quality management including validation

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