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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