Versioning of documents

The index may be issued or, so as to preclude use of obsolete indices, it may be prudent to keep no hard copies. With organizations that operate on several sites using common documentation it may well be sensible to issue the index so that users have a means of determining the current version of documents. 

The identity of custodians of controlled copies of documents should be defined in the Validation Plan, the Project and Quality Plan, or the document management procedure. The allocation of released documents to these individuals should be controlled through managed distribution lists. Superseded versions of controlled documents must be replaced in a eomprehensive and timely fashion. Obsolete versions of documents must be clearly marked as superseded. 

The model allows to express dependencies not only between document types but also between versions of documents. As it is shown in Fig. 2.8, the aforementioned dependencies between documents of types LineList, Instru-mentSpecification, and SafetyValveSpecification (cf. Subsect. 2.3.2) can now be represented explicitly through the isBasedOn relation F First, the Instrument Specification vl.O is created, based on which the Line List vl.O can be established. Next, the Safety Valve Specification vl.O can be prepared, which in turn is the basis for the generation of the Instrument Specification v2.0. 

Product management is concerned with documents such as flowsheet, simulation models, cost estimations, etc. AHEAD offers version control for these documents with the help of version graphs. Relationships (e.g., dependencies) between documents are maintained as well. Versions of documents may be composed into configurations, thereby defining which versions are consistent with each other. The manager may view the version histories... 

SDLC documentation underlies a strict approval process that is defined in the software vendor s SOPs and can be audited by customers and regulative organizations. Documents created under the SDLC are versioned and include either handwritten or electronic signatures for approval from the responsible departments. The approval also involves a member of the QA department that is independent of the project team. Different versions of documents may be created as full documents that is, the most recent version includes the entire documentation, or delta documents, that contain just changes with respect to the previous version. 

All data storage media such as floppy disks, CDs, DVDs, memory cards are placed inside the drawers, because usually they are not labeled sufficiently. Binder labels should be uniform and appropriate to regulations (e.g., colors). Older versions of documents are removed from the laboratory. 

One flaw of this scheme is that identical documents served from multiple sites have different URLs. Also, URLs leading to the same document can become different if the server host has more than one name, or file system links are modifying the directory structure of the server. An alternative to the URL scheme called URN (uniform resource names ) is currently being discussed. A URN is an unique identifier of a document similar to an ISBN number, making copies and different versions of documents identifiable. The latest proposal in this area, backed by many scientific publishers, is the DOI (digital object identifier). 

Modifications of the various versions of the AMBER parameter sets are implemented in numerous commercial and academic software packages. They are often referred to as AMBER. In every case, the user should read the documentation provided critically, and check the implementation by comparing the results of the implementation with original data. 

EDOG. EDOC, available on just the Questel system, provides in most instances less complete patent family information than either WPI or INPADOC, but it is unique in including Japanese C-level documents and also some AustraUan data not available in the other two databases. It is possible on occasion to find family information from before 1970 in this database, though such data are not provided systematically. The abiUty to search by the EPO-modified version of IPC is unique. Its value is tempered by the fact that output does not even include tides, much less abstracts of patents. That output can, however, be transferred by cross-file search protocols to more detailed files, such as WPI. 

For any chemical whose identity is claimed as a trade secret, you must submit to EPA two versions of the substantiation form as prescribed in 40 CFR Part 350, published July 29, 1988 In the Federal Register (53 FR 28772). Use the order form In this document to obtain a copy of the rule and substantiation form. One version identifies the chemical the second version does not Identify the chemical specifically, but provides instead a generic identity. Only this latter version will be available to the public. For further explanation of the trade-secret provisions, see the instructions below... 

The first part of this section is an edited version of Appendix K of the Technical Guidance for Hazards Analysis. This appendix is entitled "Evaluation Guide for Available Computer Applications Addressing Emergency Response Planning". (EPA document)... 

The 1987 version of ISO 9001 required the quality policy and the quality system procedures and instructions to be documented, clearly identifying three levels of documents in practice, organizations produced an intermediate level between the quality policy statement and the procedures which addressed the requirements of the standard and cross-referenced the associated procedures. This intermediate level together with the quality policy statement was often referred to as the quality manual. However, some manuals merely paraphrased the requirements of the standard, some described the quality system, and others confined the manual to the organization s operational policies. The guidance given in clause 5.3.1 of ISO 9004-1 suggests that the quality system documentation consists of policies and procedures. Clearly these policies are of a somewhat lower level than the corporate quality policy addressed in Part 2 Chapter 1. 

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. 

There are two types of external documents, those in the public domain and those produced by specific customers. In some cases the issues of both types of documents are stated in the contract and therefore it is important to ensure that you possess the correct version before you commence work. Where the customer specifies the issue status of public domain documents that apply you need a means of preventing their withdrawal from use in the event that they are revised during the term of the contract. Where the issue status of public domain documents is not specified you may either have a free choice as to the issue you use or, as is more likely, you may need to use the latest issue in force. Where this is the case you will need a means of being informed when such documents are revised to ensure that you can obtain the latest version. The ISO 9000 series for instance is reviewed every five years, so could well be revised at five-year intervals. With national and international legislation the situation is rather different as these can change at any time. You need some means of alerting yourself to changes that affect you and there are several methods from which to choose ... 

The term issue in the context of documents means that copies of the document are distributed. You will of course wish to issue draft documents for comment but obviously they cannot be reviewed and approved beforehand. The sole purpose of issuing draft documents is to solicit comments. The requirement should be that the documents are reviewed and approved prior to use. Some organizations insist that even drafts are approved for issue. Others go further and insist that copies cannot be taken from unapproved documents. This is nonsense and not what is intended by the standard. Your draft documents need to look different from the approved versions either by using letter issue notation (a common convention) or by printing on colored or watermark paper. If the approved document would carry signatures, the absence of any signature indicates that the document is not approved. 

The pertinent issue of documents may not be the latest issue. You may have reason to use different issues of documents such as when building or repairing different versions... 

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. 

If you do not have a means of readily distinguishing the correct version of a document, amendment instructions should require that the version being replaced is destroyed or returned to the document controller. If you allow uncontrolled copies to be taken, removal of obsolete documents becomes more difficult. However, providing you have a... 

One way of identifying obsolete documents is to write SUPERSEDED or OBSOLETE on the front cover, but doing this requires that the custodian is informed. When a version of a document is replaced with a new version, the withdrawal of the obsolete version can be accomplished in the amendment instructions that accompany the revision. When documents become obsolete by total replacement, their withdrawal can also be accomplished with the amendment instruction. However, where a document becomes obsolete and is not replaced there needs to be a Document Withdrawal Notice which informs the custodian of the action to be taken and the reason for withdrawal. 

The 1987 version of ISO 9001 required that documents be reissued after a practical number of changes have been made but this provision has been removed. 

The draft version of the Environmental management systems—Specification with guidance for use document, ISO 14001, is organized into the following sections ... 

This is an abridged version of the document Conformational Nomenclature for Five- and Six-membered Ring Forms of Monosaccharides and their Derivatives. Recommendations 1980 [3],... 

Dr. Charles Dumoulln is acknowledged for writing the original version of the Polymer Analysis program. Annmarie Lareau made some revisions and documented the code. 

Product specification documents and analytical test methods—In preclinical development, these are important documents and they evolve along with the development phases. Drug substances and products for clinical trials are tested based on these documents, and so are the stability samples. It is critical to ensure that the analyst will perform the right tests against the right specifications with the correct version of the test method. Therefore a mechanism must be in place to control these documents. This can be done manually or with TIMS. A manually controlled system would require the analyst to sign out hard copies of the documents from a central location. After the testing is done, the analyst would have to return these controlled documents to the... 

Standard operating procedures (SOPs)— The SOPs are controlled in a way similar to that of specification documents and analytical methods. It must be ensured that the correct versions of the SOPs are accessed and used by the scientists. After use, the hard copies should be destroyed and disposed of properly. An added requirement is that the SOPs should be accessible during working hours without interruption. Hard copies should be available at a manageable location so that the SOPs are available when the electronic system is down. 

The version of the document signed (or indication that the document was locked once signed). 

Another common problem is the failure to understand that, when using a merged system (some combination of paper and electronic records), both are the real SOPs, protocols, etc. As SOPs and protocols are transferred from paper to electronic media, frequently a signed, hard copy and an approved electronic version of the same document are maintained. Users of merged systems must remember that one must be able to demonstrate that the paper and electronic versions of an SOP, protocol, etc., are exactly the same. For example, if the SOP is signed on a certain date, the electronic version must also indicate that approval occurred on the same date. This means that a procedure (i.e., SOP) for ensuring document equivalency must be available and followed. 

Are electronic/hard copies maintained for all versions of software and documentation ... 

---