Invalid documents

Are all obsolete or invalid documents removed from use, or suitably identified ... 

The standard refers to invalid documents as well as obsolete documents. Invalid documents may not be obsolete and may take several forms. They may be ... 

There is no simple way of identifying invalid documents, as the reasons that they are invalid will vary. By printing authentic documents on colored paper or providing paper with a special header one can inject a degree of control. Placing the approval signatures on the front sheet will immediately identify an unapproved document. However, the onus must rest with the user who, if properly trained and motivated, will refrain from using invalid documents. 

A master list of all available documents with their revision status must be established and be available to all personnel to avoid the use of invalid documents... 

The control which you exercise over external documents is somewhat limited. You cannot for instance control the revision of such documents therefore all the requirements concerning document changes will not apply. You can, however, control the use and amendment of external documents. You can control use by specifying which versions of external documents are to be used and you can remove invalid or obsolete external documents from use or identify them in a way that users know that they are invalid or obsolete. You can control the amendment of external documents by controlled distribution of amendment instructions sent to you by the issuing agency. 

The standard requires that a master list or equivalent document contol procedure identifying the current revision status of documents be established and be readify available to preclude the use of invalid and/or obsolete documents. It is important to note that this requirement only applies to documents and not to data. 

The standard requires the supplier to ensure that invalid and/or obsolete documents are promptly/ removed from all points of issue or use, or otherwise assured against unintended use. Again you should note that this requirement does not apply to data. 

It is unnecessary to remove invalid or obsolete documents if you provide staff with the means of determining the pertinent issues of documents to use. There are often valid reasons for retaining obsolete documents. What may be obsolete in one situation may not be obsolete in another. In simple terms an obsolete document is one which is no longer required for operational purposes. As stated earlier, there are cases where various issues of the same document may need to be used and in such cases none of the documents is obsolete. One may need to remove copies of previous versions of a document but retain the master for reference purposes. You cannot demonstrate to an assessor that you corrected a deficiency if you don t retain the version that contained the deficiency as well as the subsequent version. 

How do you ensure that invalid and/or obsolete documents are assured against inadvertent use ... 

The major category of nonconforming work is allocated for any failure of a system to comply with the requirements of the Standard which could lead to invalidity of test results. Examples include absence/non-implementation of a document control system, absence/non-implementation of a procedure for internal audit or management review, staff not technically competent to perform particular tests and failure to control the quality of test data. 

For cumulative data, a frequently heard, but not well documented, argument is that these are not independent of each other because any observation i +1 depends on the previous observation i. It cannot be seen how this could invalidate the usual statistical analysis. 

A master list or an equivalent document control procedure Identifying the current revision status and distribution of documents In the management system shall be established and shall be readily available to preclude the use of Invalid andfor obsolete documents. 

Process simulation units shall not be required to be inverted at some point during the incubation period. All hlled units shall be sufficiently manipulated to assure the contact of all sterile surfaces by the growth media prior to incubation. Momentary inversion of test units shall be surfaces of the container/closure system. Reconciliation requirements of process simulation units shall be equivalent to the requirement for production. The target will be 100% reconciliation/accountability of all hlled units. Any excursion must be investigated and documented however, a variance is not an automatic invalidation of a process simulation test. Process simulation testing shall simulate normal production as closely as possible because its purpose is to assess the potential of contamination in units representative of normal production. 

An auditor or inspector s responsibility is to present and document the facts They do not invalidate studies, and they do not levy fines or penalties. 

Detailed review of reported data reduces laboratory risk of producing invalid data. Important features of internal data review are the spot checks of calculations the verification of the acceptability of calibrations and laboratory QC checks and the second opinion in data interpretation. Laboratories document internal review in appropriate checklist forms that are kept on file with the rest of the project documentation and sample data. The internal data review process is generally described in Laboratory QA Manual and detailed in appropriate SOPs. 

In particular, there will be assumptions about system structure, and these can be the most difficult ones to recognize and allow for. For example, a hacker who is trying to penetrate a system and obtain confidential data will by means of probes and experiments be building up one body of knowledge and assumptions about how the system is structured, in particular how its defenses are organized. A system administrator will, through experience of the system, access to its documentation, etc., have a perhaps very different and much more detailed set of information about how the system is (assumed to be) structured. (And the hacker may well have found, or indeed managed to insert, vulnerabilities (i.e., faults) into the system, which in effect—did he or she but know it—completely invalidate the system administrator s information and assumptions )... 

Validation of computer systems—The role of QA is of particular importance with respect to complying with Part 11, related to electronic records and computer validation. Clinical QA must ensure that any computerized system associated with a study is adequately validated and that the documentation for that validation is concise, complete, and available for audit. Clinical QA must provide the appropriate guidance to both the validation and information technology groups to ensure that clinical studies are not invalidated because of inadequately validated software or hardware. 

Failed or invalidated media fills were not reported as deviations and investigation is not documented according to firm s SOP. 

Second, data can also occur as the value of an attribute to the element. In the example above, the element has two attributes, version= "l. 0" and convention "inchi". Both the name of the attribute and its value can be enumerated if needed by the schema if the attribute is unknown, or its value is outside defined limits, the entire document or datument can be flagged as invalid by suitable software. Thus has attributes elementType="C" and x2 = "-5.4753". For the former, a value of C is allowed (because it is recognized as the standard symbol for the chemical element carbon), but a value of say CX would not be allowed. The second attribute is defined (in the schema) as the x coordinate of a set of two-dimensional molecular coordinates. As such, its presence implies that it should be paired with a yi coordinate. One can specify in the... 

These general tools are called schemas, and the process of checking XML documents against schemas is called validation. A valid XML document is a document that conforms to some schema. It is important to note that the validity concept is not as precise as the well-formedness concept. The XML document is either well formed, and then any XML processor is able to read it, or it is not well formed, and then any XML processor is required to reject it. However, an XML document can be valid according to one schema and invalid according to another schema at the same time. 

Another document that requires the signature of the researcher is the affidavit. Affidavits are sworn papers submitted to the Patent Office to prove or disprove facts. Examiners rely on these papers to deny patentability of the invention. If an affidavit, submitted during the prosecution, convinces the examiner of the applicant s position, and the affidavit later proves to be false or falsified, the patent is invalid (9,10). Thus, utmost care should be taken in preparing an affidavit. 

Testing of special values (input of zero or null) and testing of invalid inputs. .. are not documented. 

It is essential to document all outstanding issues and include a plan to resolve these, no matter how small. This plan should include the name of an accountable person responsible for the action item and the estimated completion date. In the system acceptance report, specific reasons for determining that the system is validated should be stated this statement should take into account outstanding issues. Many minor issues can render a system invalidated ( death by a thousand cuts ). 

The decision on issuing the previously mentioned documents is made at an extended session of the Board of the PC. They become invalid within 2 months if a manufacturer fails to receive in due course registration or re-registration certificates on medicinal products. 

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