Optimize Your Pipeline Integrity Data Management for Pharmaceutical

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[Music] steps to minimize the data integrity risk data security and has become a hot issue in pharmaceuticals over the past few years because the fda and other regulatory agencies have issued many warning letters and import alerts due to lack of data integrity in records recently fda has published a guideline in the form of question and answer for the compliance of data integrity in firms these documents clarify the expectations of the fda from pharmaceutical firms regarding data integrity ing to the concept of alcoa data should be attributable legible contemporaneous original and accurate data should be accurate and unchanged during its whole life data must be recorded at the time of the activity as being done and it should not be backdated the use of computers in industries is common and in the age of computers it is easy to generate records sometimes it happens unknowingly but in most of the cases employee generates the data to take a shortcut or due to excess workload following are some strategies to minimize the risk of data integrity issues in pharmaceutical industries one audit trail implementation an audit trail in any computerized system records all activities conducted on it it records user identity date and time of the activities done on the system audit trial helps to ensure the authenticity of the electronic records and their modification of deletion from the system each and every computerized system must be audit trail enabled two implementation of 21cfr part 11. 0.21 cfr part 11 has guidelines for the maintenance of electronic records alcoa principles are helpful to implement the recommendations of the 21cfr all electronic documents must have electronic signatures to make them trustworthy and reliable 3. computer system validation computer software is responsible for the working of computerized systems therefore all software used in computerized systems in the firm must be validated software validation ensures the efficient and error-free working of the computerized systems in most cases the software vendor provides the software validation and the firm should ask for the same 4. secure documents and record pharmaceutical records must be secured and must not be accessible to all personnel access to the record should be restricted and authorized personnel must be allowed to access it the electronic data must also be password protected and it should be assessed by username and password 5. backup and recovery each and every file of electronic record as important therefore a strategy for backup and recovery of data must be implemented periodic backup of data should be taken and must be stored in the form of dvds or other data storage devices so that it could be restored in any unexpected event of data loss from the instrument 6. user training proper training of the employees should be given for their assigned jobs special training for record maintenance and data integrity must be provided to all employees the training for data maintenance should be included in the training calendar to repeat it periodically 7. internal audits internal audits provide confidence to the employees and ensure the implementation of the procedures the errors and problems found during the internal audits are rectified and continuous improvement in procedures and records take place as you know data integrity has its importance in the industries the impact of unprotected records can be dangerous for their reliability as well as product quality i have written many articles on data integrity because data quality is not a focal point for many companies and issues are being raised by regulatory agencies record maintenance is entirely different from data integrity it is not necessary that a properly maintained record would have integrity and accuracy don't forget to subscribe to this channel and also hit the bell icon to get regular updates thanks for watching this video watch more videos as we have created a lot of videos for pharmaceuticals