Documentation numbering system

The standard doesn t require a procedure covering inspection and test status however, as clause 4.2 requires a documented quality system, you will need to document the methods employed to denote inspection and test status. If you use stamps you will need a register to allocate stamps to particular individuals and to indicate which stamps have been withdrawn. When a person hands in a stamp it is good practice to avoid using the same number for 12 months or so to prevent mistaken identity in any subsequent investigations. 

What does document control system mean Every document must be clearly identifiable. This includes a unique number and revision status to show if this document has been revised. It could be useful to include the type of document into the number to ease the operation of the system. This is demonstrated on the slide with an SOP as example. 

The initial assessment should be undertaken early in the planning phase and include definition of system boundaries in order to determine and document what systems are to be in the validation program and why. A sitewide inventory should assign each computer system a unique number, descriptive title, and location reference. The main software and hardware components of each system... 

A systematic and traceable documentation, for sampling, preparation and analysis of the samples, gives overview and saves time. Easy-to-use forms for the field sampling with columns for sample numbers, pumps, date, sampling time, flow etc. should be prepared. A traceable number system must be build up, so the sample easily can be traced back to the sampling place. The notes must be legible and shortly describe the sample from sampling to results. 

An effective sample numbering system should be developed in the planning phase and documented in the SAP. Several practical rules for sample numbering are as follows ... 

All pages of paper submissions must be numbered using any numbering system. Paging and indexing must provide rapid access to the entire submission. For electronic submissions, pagination should be provided only for individual documents. 

Additional copies are available from the Internet at http //www.fda.gov/cdrh/ ode/1585.pdf, or to receive this document via your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number (1585) followed by the pound sign ( ). Follow the remaining voice prompts to complete your request. 

A requirements trace matrix (RTM) is a tool to map requirements. However, these can become large and difficult to maintain. An alternative approach is to provide implicit traceability by having a common structure and numbering system for all system design and test documentation. The one area where this is often difficult to achieve is with the User Requirements Specification (URS). The URS often covers not only the DCS requirements but those of the wider project, and is also produced before the system vendor has been selected. In this case a requirements traceability matrix should be generated to confirm requirements relevant to the DCS are addressed within the functional specifications. 

In a paper-based data flow, as CRFs are received by the sponsor, the pages or forms can be logged in or identified to the system. A document number may be used to uniquely identify a page for further tracking within the database. This document identifier can be scanned from a barcode printed on a form, created using a document number generator, or manually entered. 

Machine language is not necessarily a code which can be recognized as easily as a combination of numerals or other symbols. Thus, machine language is implied when a hand-sorted punched card is notched in a certain position to record a certain aspect of subject matter contained in a particular document or when a hole is punched in a certain position in a peek-a-boo type of system (50), or a document number as recorded in a certain position by pen, pencil, or stamp, as in the Uniterm system (45). 

The purpose of a numbering system for the documentation is to ensure an unambiguous identification of each validation/qualification document produced within the field of application of the Validation Master Plan. The document number is a combination of letters and numbers with a length of 10 or 11 characters. An example of such a document number might be ... 

Concept of qualihcation/validation. This takes into consideration the concept of validation life cycle for the company s facilities, equipment and processes, documentation format, and numbering system. 

Documentation format of qualification programs Numbering system Revalidation Facility description Description of building... 

The revised ISO 9002 (July 1994) numbering system has been adopted throughout this document because many suppliers already use the standard as a basis for their quality system, including those companies which already have third party certification. Requirements specific to the manufacturing of excipients have been included under each of the ISO headings. 

There shall be a numbering system to identify the version and category of the document and its establishing date. 

Additional Safety Instrumented Systems information is available in the Rosemount 30S1S Series Pressure Transmitter reference manual (document number 00809-0100-4801)... 

This Appendix gives an example of a USNRC Regulatory Guide and a chapter of the Standard Review Plan to provide useful reference technical information and data. The numbering system and cross-references of the original documents are retained. All illustrations in the original documents have been removed. 

A document control system, including standard practices for numbering documents, their filing, the system of document approval and authorization of issue, distribution control, revision control, and archiving. 

---