Maintaining document standards at Kreara
Prepared by Sreedevi Menon
Documentation is an integral part of clinical trial studies and maintenance of standards while preparing various documents is of utmost importance. The documents related to clinical trial study may be anything from SOPs to documents related to project management, data management, statistics or SAS.
At Kreara, all or some of such documents are prepared as per requirement of the study. The emphasis is not only to make these documents as informative as possible but also to convey the information in a concise and effective manner. Further, effort is taken to maintain the quality of the information contained and the way of presentation.
An SOP for General Documentation Guidelines is maintained at Kreara and all personnel in the organization are trained on the same. This standard operating procedure describes the various guidelines to be followed during preparation and amendment of SOPs in general. It also presents guidelines for preparation of project related documents like the naming conventions to be followed.
In addition to this, individual SOPs are maintained for each and every document and to maintain standards, templates with instructions regarding the contents, layout and formatting of the contents are maintained in a central repository. The personnel responsible for writing the documents are required to follow the format in the templates while preparing the documents. The QC personnel check for any non-compliance to templates in the document in addition to the relevance of contents. Further the QA manager is responsible to ensure that the process is followed correctly.
The personnel at Kreara are trained in the SOPs related to document writing. A great deal of exposure in the related field is provided to them so that they are capable of preparing informative and effective documents.
Documentation is an integral part of clinical trial studies and maintenance of standards while preparing various documents is of utmost importance. The documents related to clinical trial study may be anything from SOPs to documents related to project management, data management, statistics or SAS.
At Kreara, all or some of such documents are prepared as per requirement of the study. The emphasis is not only to make these documents as informative as possible but also to convey the information in a concise and effective manner. Further, effort is taken to maintain the quality of the information contained and the way of presentation.
An SOP for General Documentation Guidelines is maintained at Kreara and all personnel in the organization are trained on the same. This standard operating procedure describes the various guidelines to be followed during preparation and amendment of SOPs in general. It also presents guidelines for preparation of project related documents like the naming conventions to be followed.
In addition to this, individual SOPs are maintained for each and every document and to maintain standards, templates with instructions regarding the contents, layout and formatting of the contents are maintained in a central repository. The personnel responsible for writing the documents are required to follow the format in the templates while preparing the documents. The QC personnel check for any non-compliance to templates in the document in addition to the relevance of contents. Further the QA manager is responsible to ensure that the process is followed correctly.
The personnel at Kreara are trained in the SOPs related to document writing. A great deal of exposure in the related field is provided to them so that they are capable of preparing informative and effective documents.
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