Documentation, supporting changes

If one looks at the various clinical stages of development, there is a question as to what practices should be in place to support phase I, II, or late phase III studies. An all-or-nothing approach to GMPs is not appropriate. There are certain fundamental concepts that must be applied regardless of the clinical phase of development. Examples of these include (1) documentation, (2) change,... 

Chapters 11-13 cover the selection and sizing of downstream disposal systems, reaction forces which require piping and vessel supports, maintenance, documentation and change management. Additional material is given in Annexes 1-8 and is referenced from the,text as required. This includes consideration of any safety factor to be applied to the calculated relief size. 

There are several sections of the CFR that address the control of documents. Obviously, documentation supporting each phase of the life cycle of the master production record should be maintained under change control. A change control program at these early stages will verify that appropriate departments are part of the review process and that changes are not made without sufficient data support. 

Document changes will normally result from modifications to the LIMS hardware and software. The documentation supporting the maintenance of the LIMS in terms of hardware and software should be reflected in the existing documentation. Any documentation that is out of date should not be utilized for maintenance purposes. 

Haney, W., Russell, M., Bebell, D. (2004). Drawing on education Using drawings to document schooling and support change. Harvard Educational Review, 74(3), 241-271. 

It is incumbent upon the toller to develop and follow internal management systems as appropriate to support business needs, production needs, process safety, environmental responsibility, and worker health. The selection process should have considered whether or not satisfactory systems are in place. Nevertheless, the contract or auxiliary documents may be the vehicle used to help ensure that the system reviewed is the system actually used for completing the toll in question. Within the process safety management system, the management of change and training elements are essential subsystems. 

During the course of its conduct, the sponsor may need to amend a clinical trial, as a consequence of the emergence of new information. If the amendments are deemed to be substantial, in that they may impact on the safety of trial subjects, or change the interpretation of the scientific documents in support of the conduct of the trial, or are otherwise significant, the sponsor shall notify the Competent Authority and the Ethics Committee, using a Trial Amendment Form. The Ethics Committee are permitted 35 days to approve the amendment. 

The validation umbrella not only covers in-house systems, but also covers vendor systems. Much of industry today is dependent to some extent on vendor-supplied electronic systems and, consequently, the vendor s validation of those systems. Because of this, there are validation issues to assess at the vendor including how the vendor addresses change control, testing and documentation, source code, integration, and implementation of the system during development. Implementation support also must be assessed. 

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