FDA警告信—变更控制（计算机系统系列）

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FDA Warning Letter - Change Control


Date: 25 Aug 11
Link: FDA Warning Letter (New Window)

ObservationThis observation relates to the revalidation following changes of a Cutting and Packing Machine, however it could be applied to any computerised system. 2. Your firm failed to ensure that the automatic, mechanical, or electronic equipment, or other types of equipment including computers or related systems, will perform a function satisfactorily [21 C.F.R. § 211.68(a)]. For example:

a. The initial qualification for the (b)(4) Cutting and Packing Machine, Model (b)(4) was completed on June 7, 2007. Approximately 25 major and minor changes were implemented between June 14, 2007, and July 15, 2010, before your approval of the re-qualification report for equipment (b)(4).

In your response, your firm states that (b)(4) Cutting and Packing Machine is a custom-made unit. The unit consists of subunits that perform functions independently of one another and that modification to one subunit does not necessarily adversely impact other subunits or the equipment as a whole. You added that the requalification requirement was documented in each approved Change Control. Your response, however, is inadequate because you have neither provided documentation to demonstrate your claims of independently functioning subunits, nor have you provided your rationale why each equipment change did not necessitate a re-qualification and/or a re-validation of the (b)(4) Cutting and Packing machine. （未提供相应的文件证明亚单元系统的功能独立性，同时也没有提供设备的变更为什么进行再验证的合理理由）

In addition, your firm states that further system enhancement will be made to validation procedures. However, it is not clear as to your estimated completion date because the content of your proposal entitled, “(b)(4),” is so broad（纠正措施过于宽泛，不具体，没有执行性，同时无法进行有效评估（比如纠正措施的输出，以及前期制定的相应评估标准等））. Furthermore, we are not able to evaluate the adequacy of your corrective actions without sufficient details of your proposed enhancement.

CommentAlthough this change may relate to mechanical and / or software changes the FDA regulatory requirement could apply to any Computerised System (automation, laboratory or IT system).

It is rarely practical or possible to perform a full revalidation following a change（进行full revalidation一般情况下没有必要，可做局部再验证topical revalidation，特别是针对于大型的自动化系统）, particularly for large automation systems.  However each change should be Risk Assessed to determine the potential impact on the overall system.（每个变更都应就其对整个系统的潜在影响的风险评估）  For software systems the modularity of the software can be used to support mitigation（软件的模块化）, but a sound rationale must be provided to determine that the correct level of verification（确认的级别） has been performed for each change and that the impact to patient safety, product quality and data integrity have been maintained.（三个层面，对患者安全性的影响，对质量的影响，对数据完整性的影响）

Following a Risk Based approach to the validation and control of the system the risk assessments performed during the design phases should have identified the Quality Critical Attributes（在设计阶段就应该通过风险评估识别相应系统的质量关键属性，同时用于后期的变更确认级别选择的支持）.  This also should be used to support the approach to the verification following a change.  Should a change be performed that has the potential to impact a Quality Critical Attribute of the system then the risk assessment for the change should identify consider the potential impact.  Following the commissioning of the change (to demonstrate that the change functions as required) then re-verification of the critical attribute should be tested; this may be as simple as running the initial test script.

Managing risk and formally documenting the risk assessment process will provide sufficient detail to demonstrate that the change to a computerised system has been implemented and the risk to quality controlled and minimised.（风险管理很重要啊！！）

A formal periodic review process should also consider the cumulative impact of change, along with quality events (incidents / deviations) to determine whether further controls or verification are required to maintain the computerised system within a qualified state.（正式的周期回顾应该考虑到积累的变更，以及质量事件以决定是否采取进一步的控制以及再确认，从而维护系统的验证状态）

Comments are always welcome.

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Labels: FDA Warning Letters, Quality Risk Management

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