Documentation control systems

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. 

A document control system is in place Purchased materials meet specified requirements... 

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. 

If the laboratory s documentation control system allows for the amendment of documents by hand pending the re-issue of the documents, the procedures and authorities for such amendments shall be delined. 

The documents are reviewed for their adequacy before approval. The document control system is designed to ensure that the information used in the production of the product or parts is clear, complete, correct, and current. No changes can be made without authorization. The system operates within a contractual constraint that requires all products or parts to be built to blueprints, drawings, or other specifications. All personnel are required to immediately report any discrepancy to the proper supervisor so that corrective action can be taken. Documentation shall include one or more of the following, but is not limited to ... 

The standards and customer drawings/specifications are included in the document control system. 

Documentation will typically comprise validation life-cycle documents and procedures, SOPs, training records, quality records and procedures, process and engineering data, drawings, manuals, and spares list(s), and includes copies of the software. These originate from both the pharmaceutical manufacturer and the supplier. The documents must be verified as approved and on file under a document control system. The documentation must be located or stored in a controlled environment. 

Document control Systems that define data handling and management, report generation, record retention and retrieval, and security... 

Document Control Systems—SOPs, protocols, protocol amendments, final reports... 

A documentation control system that keeps track of all procedures, records, and reports. 

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. 

The amount of work needed to do this properly is too often underestimated, with consequential overload and inefficiency. The document control system is the nervous system of the project, overseeing the transmission of information. Both order and speed are essential. This means that the resources available for this operation must exceed the average need, or there will be delays during peak loads. 

Access the facility s PSM element administrative procedure from the facility document control system. 

Reviewing the upgrade - Identify the appropriate reviewers for this document. The facility document control system or PSM/RMP administrative procedures may provide some guidance. The review process for any procedure is an excellent opportunity for employee participation. Consider having hourly, technical and management personnel involved in the review. 

It should be easy to change. A careful document-control system is needed to ensure that everyone involved with a project knows the current version of the requirements. 

It is important for a company to have a document control system. This system is a formal system that controls how documents are updated so that there is always a record of how designs or operations evolve over time. The document control system is the company s primary document control system and is not just for safety information management. That is covered in the next section. 

Associated with the physical handling and storage of materials is an information- and document-control system. The information- and document-control system provides for ... 

Many information- and document-control systems are standard features of current warehouse management systems (WMSs).The cost-effectiveness of snch systems over manual systems depends on such factors as ... 

The EPCM contractor s document control system will be operative from start to finish embracing all phases of the project. The site document control system will be as it were an extension of the over all project system. The latter normally includes the following features ... 

Owing to the volume of documents required to support an SAR, a document control system should be established to manage the indexing and to control the issue of the separate documents that make up the SAR. This system shall control the updating, revision, issue or removal of reports in accordance with a QA programme so that the information is always up to date. 

The operating organization should establish a document control system to ensure that all documents affecting activities important to safety are issued, updated, filed and distributed in such a manner as to prevent the use of superseded documents (see Ref. [8], Safety Guide Q3). 

Procedures shall be established to ensure that controlled documents and drawings necessary to accomplish activities are available at the locations where the activity will be performed prior to commencing the work and that obsolete or superseded documents and drawings are removed and replaced by applicable revisions In work areas In a timely manner. A master list or equivalent document control system shall be established to identify the current revisions of controlled documents and drawings. 

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