Pharmaceutical Technologist - November 2007 - (Page 21)

// Perry Table 1 Examples of features in some EDMSs. EDMS functionality System notifications Benefits This can minimize communication ‘falling through the cracks’ and reduce, or even eliminate, the number of failures to comply with reporting period regulations (study and investigator information, adverse event reports). An EDMS with notification functionality serves as an automatic communicator, sending an alert when documents are changed, under review or approved. This information can help a regulatory affairs professional plan and facilitate upcoming submissions by initiating communications with the functional areas preparing documents for submission. This sends users messages about the documents requiring the user’s action. The level of detail and number of messages vary from system to system, but examples include: notification of a document change and the distribution of a document to a user of a work flow action required of the recipient (e.g., document editing, review or approval). Most EDMS allow for incremental document versioning as files are modified and brought back into the system. Version increments can vary using minor versions (0.1, 0.2), as well as major versions (1.0, 2.0). According to generally accepted guidelines, major versions represent effective versions that have passed the approval stage, while minor versions connote in-between drafts and reviewed versions. These required features are invaluable tools when regulatory professionals need to: Search for content that will be used in a current submission ● Find out what version of a document was used in a previous submission. ● System messaging Versions Searches and audit trails Life cycle states These are used as labels for versions of documents to indicate where they are in the document’s life cycle (draft, approved, superceded or retired). Some EDMS permit configurable life cycle states for documents, making it possible to assign the status “submission ready” to documents that have been approved for submission by a regulatory affairs professional, or “submitted” to indicate a document version that was submitted. Life cycle states provide more value to version numbers, as some EDMS allow for multiple life cycle state to the same version. This is important for regulatory affairs because if a functional area approves a document as version 1.0 (approved), regulatory affairs can circulate the same without changing the version number (1.0, approved, submission ready). It would be misleading to have 1.0 approved and 2.0 submission ready, as it would appear that the document had changed between being approved by the functional area and being approved by regulatory affairs for use in a submission. This enable documents to be seen by, or hidden from, users depending on their role or group. This is a particularly powerful tool if set permissions can be defined by life cycle state, thus eliminating the accidental use of incorrect, superseded or unapproved versions of documents in submissions. This allows relevant information to be used when referring to documents. For example, when using an attribute to search for a clinical document, one may look for the study number or the clinical study component (protocol, CRF, investigator CV) that classifies that document. Careful labelling of attributes and metadata is critical for searching for, as well as organizing, such documents. Similarly, document types can be used to label published output with information such as submission date, application type or submission category if they have been submitted to an agency. This can be applied for documents that require periodic review or submission. This will send a “reminder” message. eSignatures eliminate the time wasted in creating a paper document and then scanning back into electronic form. To be 21 CFR Part 11 compliant, electronic signatures must include name of user, date and time of signature, and meaning of signature. Permission models Document types/classes Review period notification eSignature capabilities www.ptemagazine.com 21 http://www.ptemagazine.com

Table of Contents Feed for the Digital Edition of Pharmaceutical Technologist - November 2007

Pharmaceutical Technologist Contents Editor's Comment News Morpheus Feeling the Pressure Legal Crusaders The Holy-Grail of Start-Up Biotech Special Feature Q&A

Pharmaceutical Technologist - November 2007

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.