Documentation standard

The presentation will focus on the differences and similarities of these systems as well as problems encountered in their practical use. By looking at the analytical process chain characteristics, such as the reliability and traceability of data, documentation standards and total costs of QM are discussed and evaluated. Suggestions for harmonization of QM-Systems and reduction of bureaucracy will be made, resulting in an improvement of the overall practical applicability and cost reduction of QM. 

Work instructions define the work required in terms of who is to perform it, when it is to commence and to be completed, what standard it has to meet, and any other instructions which constrain the quality, quantity, delivery, and cost of the work required. Work instructions are the product of implementing a control procedure, an operating procedure or a document standard (see further explanation below). 

What Is the Expected Output or Work Product. The specific form of the finished product will vaiy according to your company s practices and needs. However, it s reasonable to expect that the team s efforts will ultimately produce a set of documented Standard Operating Procedures (SOPs) for the management system, or their equivalent within your organization (see Section 6.3). Interim work products may include progress reports (see Chapter 8), documentation of discussions and analyses, flowcharts, or other materials. 

The standard of any steps of manufacture and quality control conducted outside Australia must also be shown to be acceptable for the Inclusion of therapeutic goods on the ARTG. The TGA document Standard of Overseas Manufacturers specifies what is regarded as acceptable evidence of GMP standards, and Is available on the TGA website. The TGA will accept GMP certification only from coimtrles where It Is satisfied that the standard of GMP inspection is equivalent to GMP Inspections In Australia. 

The VMP should be a summary document and should therefore be brief, concise, and clear. It should not repeat information documented elsewhere but should refer to existing documents such as policy documents, standard operating procedures (SOPs), and validation protocols/reports. The documentation format is illustrated in the VMP. 

We assume that the models have been checked against relevant consistency and correctness criteria (e.g., by checking them against documentation standards and by passing them through an inspection process). 

After the authentication, the Secretariat s Office of the Internal Oversight (OIO) then certifies this data. The OPCW Laboratory has a quality system, which has been accredited by the Dutch Accreditation Council (RvA). The accreditation covers the quality system as well as the specific activity of the OCAD process and other processes. The OPCW Laboratory has in place quality documents (standard operating procedures (SOPs) and work instruction) for the OCAD process. 

ICM Topic S2B Document Standard Battery of Genotoxicity Tests. ... 

A lack of sufficiently documented standard operating procedures describing an IRB s procedural responsibilities and activities. 

Documentation standards should be defined so that there is consistent document layout, style, and reference numbering. Documents should be clearly marked as draft until they are formally released. Version control should be apparent. The version identifiers should distinguish documents under development (drafts) from those that have been issued formally. Documents should include a document history section to log the changes made in successive issued versions of the document. Individual documents should have the following controls ... 

Clear and Concise Documentation shonld conform to document standards and should be readily understandable. 

OQ testing should only be conducted after the IQ has been successfully concluded. The scope of the OQ should be dehned in the Validation Plan. System Testing can be repeated or referenced to reduce the amount of OQ testing required, provided supplier documentation standards fulfill user qualification requirements. The OQ should cover ... 

The system has been inadequately tested, or the testing has been inadequately documented. Documented standard procedures for the development, maintenance, operation (including security), or use of the system are inadequate. 

Level 3 The qnality processes for both management and engineering activities is documented, standardized, and integrated into a standard quality process for the organization. 

The user is responsible for the entire validation. One part of this overall validation process is to obtain documented evidence about the proper development according to documented standards. To have this assurance, a vendor assessment program should be developed that may include formal written procedures for the selection, evaluation, and qualification of vendors. 

A documentation standard for the PQ test plan can be found in the IEEE standard 829-1998, presented in Table 20.4. The key sections of a PQ test plan are the features to test and those that will not be tested and associated with the features to be tested are the written notes of the assumptions, exclusions, and limitations to the testing imdertaken. The assumptions, exclusions, and limitations of the testing effort were recorded in the appropriate section of the qualification test plan to provide contemporaneous notes of why particular approaches were taken. This is very useful if an inspection occurs in the future, as there is a reference back to the rationale for the testing. It is also very important as no user can fully test a CDS or any other software application. 

Failure to adequately document standard working practices is a deficiency commonly cited by regulatory authorities.Recent FDA inspections have indicated that in some circumstances no attempt has been made to cover this activity ... 

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