Good Documentation Practices in Pharmaceuticals

In the modern day of technology, pharmaceuticals and other healthcare organization are able to exercise good documentation practices. This can be either in electronic systems or in printed form. These are the acceptable high standards through which documents are created as well as being maintained. Proper documentation enables the organization to have accurate, reliable and adequate information. However, organizations tend to lack the proper systems and structures to enhance proper documentation. The lack of proper documentation practices has been ranked the 5th among the top 10 findings by the European Medicines Agency (EMA). This calls for organizations to adopt effective and efficient strategies that can facilitate proper documentation practices in health organizations. As results, audits are regularly carried out as inspections to identify the pitfalls within the documentation process of the particular organization. This in turn enables the organization to build a documentation foundation of reliable and valid data. Such practices support the fundamental principle of safeguarding the rights of the subjects, their safety and well being.

Good documentation practices enhance efficiency within the medical organization. They are, however, achieved s only if certain aspects relating to documentation are fulfilled. For instance, the documents should be controlled within the quality system to ensure that they are of the required quality and standards. Also, the documents should be approved, dated and signed before storage. The approval and signage gives the document the legal attribute of being reliable and valid. That guarantees that they are legal and can be verified in the future by the responsible personnel. Furthermore, the dating for the documents enables the organization to have an order of sequence. Dates give the documents the actual time frames and can be used for reference in the future. The documents should be regularly reviewed. This is whereby documents are constantly being evaluated for their accuracy and relevance to ensure that they are correctly stored. In the process the responsible people are able to clear the documentation process from errors through the regular review keeping the data up to date. Another aspect of proper documentation practice is retaining the documents. This ensures that the relevant documents are stored in sequence and hence easy to retrieve. Another aspect of recommended documentation practice is that documents can be superseded within the quality system.

For good documentation practices to be realized, the management of every organization should have clearly defined responsibilities. In that case, the management can have a clear line of information flow. The management should then have defined responsibilities for information origination, maintenance, distribution, change control and archiving all the records within a particular unit or department. At the unit or departmental stage, the document owners should ensure acceptability of all documentation aspects and records management. Furthermore, the documentation system should be periodically audited by registered and reliable quality assurance entities. Through this structured documentation process, organizations are guaranteed of proper records and easy retrieval of information in their filing systems. Furthermore, this organized system of documentation enables the different types of documents found in pharmaceutical organizations to be categorized into small numbers cascading down from the quality system.

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