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[Audio] Good morning everyone. Welcome to this presentation on Good Documentation Practices and Data Integrity in the pharmaceutical industry according to ALCOA+ principles. In this presentation, we will provide an overview of the current regulatory landscape, discuss the requirements imposed on pharmaceutical companies with regard to documentation and data integrity, and outline best practices for complying with ALCOA+ principles in the year 2023. Let's get started..

[Audio] Good documentation practice is a way of ensuring that documents are written properly and with accuracy. It is essential in industries such as the life sciences where data integrity is paramount. ALCOA+ is a set of principles that ensures data integrity and provides a comprehensive approach for data management. This set of principles has been developed over many years and is now used widely in the life sciences industry. With this approach, organizations can ensure that data is reliable and trustworthy. Good documentation practices and ALCOA+ give us an insight into how to ensure good quality and data integrity in our processes in the year 2023..

[Audio] ALCOA+ is a widely used acronym in the fields of data integrity and quality assurance. It stands for Attributable, Legible, Contemporaneous, Original, Accurate, and Plus. Attributable data is traceable to the person or system which created it. Legible data needs to be traceable, readable, and understandable for its entire life. Contemporaneous data has to be captured at the time it is created or observed. Original data must be an official copy of the first capture of data or information used to reconstruct the process. Accurate data must be truthful, valid, reliable, and precise in both paper and electronic records. Plus underscores the need to achieve outstanding data quality to achieve the best result..

[Audio] Having a reliable and effective data documentation system means having up-to-date information and accurate records available when you need them. For a successful data documentation system in 2023, there are three key components to consider - completeness, consistency, and endurance. All relevant raw data and metadata must be collected and stored in a logical manner with policies or procedures to control or standardize data. Records must be kept indelible and accessible throughout the data retention period. Having the right documentation practices in place ensures that your data is always available when you need it..

[Audio] Good documentation practices and data integrity are essential to ensure accurate and reliable records in any organization. Understanding what constitutes a document and the importance of properly documenting activities is key to properly managing information. Documents can be stored in paper or digital form and can be changed or revised as needed. They help organizations keep track of activities, create legal documents, provide a historical record, provide information, and comply with regulations. Documenting activities ensures accuracy and reliability, so it is important to adhere to these guidelines to ensure a higher level of quality assurance..

[Audio] Certain characteristics must be present in all documents to be valid for 2023 standards; accuracy, authenticity, clarity, completeness, a current version, legibility, and permanence. Ensuring these characteristics are present in all our documents is essential for data integrity and quality assurance..

[Audio] Records are of immense importance in 2023 as they are essential for documenting activities and safeguarding data. GMP records must possess specific qualities such as permanence, clarity, accuracy, promptness, consistency, validity, completeness, directness, and truthfulness. Examples of GMP records include batch records, bills of materials, specifications, policies, protocols, standard operating procedures, work instructions, test methods, forms and log sheets, checklists, training assessments, electronic and hardcopy quality records, certificates of analyses, certificates of compliance, and technical transfer reports. Good documentation practices and quality assurance can only be ensured if appropriate records are maintained..

[Audio] Proper documentation practices and data integrity quality assurance are essential for the success of any enterprise in 2023. Documentation of data records processes, both internal and external to the organization, as well as keeps track of controlled documents such as Standard Operating Procedures, Formats and Annexures, to ensure its restricted access. Data, composed of a set of values of qualitative or quantitative variables, can provide valuable and useful information for decisions. Therefore, ensuring data integrity and properly documenting processes are essential steps for success..

[Audio] As we move into the year 2023, it is important to ensure good documentation practices and data integrity quality assurance. The ALCOA principles, which ensure data integrity, apply to various types of GMP records, including electronically recorded data from simple machines through to complex and highly configurable computerized systems, paper-based manual recordings, hybrid records, and photography, images, chromatography plates, and more. Data integrity is important to ensure that the records meet the requirements of GMP..

[Audio] Good Documentation Practices are essential to guarantee data accuracy and reliability. Outdated, unsigned and illegible documents or records should not be used to conduct any tasks. Likewise, photocopied pages that are faded or scrap paper or sticky notes should not be used to record data. Page removal/replacement and Ditto ( ) sign are not acceptable, and thus spaces must be filled with proper information..

[Audio] Good documentation practices are essential for quality assurance and data integrity in 2023 and beyond. In order to guarantee that all changes to any document remain traceable and legitimate, signatures, initials, or other forms of authentication should not be placed in a single line, but rather in each and every column or row of the document. Good documentation practices are essential for a successful and efficient work environment..

[Audio] In the year 2023, using a stamped signature should no longer be accepted as a good documentation practice. Handwritten signatures remain the accepted standard for quality assurance, providing the most reliable form of authentication. Securing documents with a handwritten signature is essential to ensure the integrity of the data..

[Audio] As we look ahead to 2023, the importance of good documentation practices and data integrity quality assurance cannot be overstated. This document lays out some key guidelines to help us achieve this. To begin, all records should be filled out in indelible blue ink or in accordance with a site-specific standard operating procedure. This safeguards legibility for the long-term. Ballpoint pens should be used for entries in GMP documents, whereas pencils and inks that can be easily erased should be avoided. It is also imperative to refrain from using correction fluid at all times. Adhering to these directives allows us to maintain data integrity quality assurance of the highest standard..

[Audio] Adhering to good documentation practices, including the four-eyes principle, is essential for data integrity quality assurance. The four-eyes principle requires at least two people to review and approve any critical steps. This ensures accuracy and accountability in the decision, transaction, or task being performed. After the review and approval is complete, each individual should sign and date the document to finalize the process..

[Audio] Good documentation is essential to data integrity and quality assurance. When it comes to correcting mistakes or errors in documentation, it is important to take the C L I D E method into account. This method stands for Correct, Line through the complete erroneous entry, Initial, Date and Explain. By using this method, we can ensure that the original entry can still be determined and it also makes sure that no entries are erased, obliterated, crossed out, written over or otherwise destroyed. So always remember to take the C L I D E method into account when it comes to correcting errors or mistakes..

[Audio] This slide illustrates an incorrect entry example and its optimal correction. It can be seen that the original entry contains a typo, which is removed and replaced with the correct data or information to keep the original information legible. Furthermore, it is suggested to obtain synthesis kits from a reliable supplier with a certificate of analysis as this can prevent organizations from having to execute sampling and identification testing..

[Audio] It is essential to take time and record manual entries correctly as documentation and data integrity become increasingly important. To make sure the original entry remains legible, corrections should be made using a single strike-out line. Numbering the corrections and providing detailed justification will enhance clarity for the reader. Should more than five corrections be needed on one page, they should be continued on the next page. By adhering to these steps, accuracy and legibility of our entries can be maintained..

[Audio] Data integrity and quality assurance are vital and it is important for us to keep this in mind as we prepare for 2023. To ensure accuracy, it is helpful to draw a single line through any errors that may occur. This includes transcription errors, recording errors, technical errors, mistakes with dates, and spelling issues. By using this technique, we can make certain our data is as accurate as possible..

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[Audio] In order to maintain good data integrity and quality assurance in 2023, Good Documentation Practices should be followed. This includes filling out all relevant fields on a record and marking any empty spaces, rows or columns with a single line cross or 'Z' type marking across the whole field. Where information is not required or applicable, 'Not Required' or 'Not Applicable' should be indicated with the applicable date and signature. Lastly, any entries should be marked correctly with a line from the left upper corner to the right lower corner..

[Audio] In the year 2023, companies and organizations must remain committed to good documentation practices to successfully face the unique challenges and opportunities presented. This entails completing all fields of a record and implementing Z-marking to guarantee the accuracy and reliability of the data. Doing so will ensure that the data integrity is maintained..

[Audio] Documentation practices are increasingly important in 2023. Filling remark or comment fields with the correct words is an essential part of preserving and verifying data integrity. The table below demonstrates this by showing temperature recordings labeled 'OK', verifying that the data is valid. Having effective documentation practices set up helps guarantee that the data is of high quality..

[Audio] Good documentation practices provide a foundation for data integrity. In order to ensure that data is accurate, reliable, and traceable, it is essential to have appropriate documentation practices in place. This includes signatures or initials used for signing off on any document, such as standard operating procedures, worksheets, and other GMP records. It is also important to ensure that any handwritten entries are entered in legible handwriting and signed and dated at the time the task is performed. Where possible, entries should be made with the available space provided for them, and if there is not enough space, an asterisk should be placed at the top of the entries with the additional information found at the bottom, signed and dated. By ensuring appropriate documentation practice, we can ensure that any data produced is accurate and reliable..

[Audio] Good documentation practices are essential for ensuring data integrity in the year 2023. Making sure that all machine printouts have staples, instead of paperclips, and are signed and dated adds an extra layer of protection. It is also recommended that any thermal paper printouts are copied in normal paper of A4 size before attaching to any report or filing. Furthermore, both the original and the copy of any document should be secured with the report, after making a copy. Following these good documentation practices will help prevent data loss in the years to come..

[Audio] Organizations in 2023 require good documentation practice and data integrity quality assurance to succeed. Otherwise, common document errors can cause serious consequences. These range from rounding errors, transcription errors, calculation errors, misinterpreted data, out of limits not detected, use of invalid data, lost data, incomplete documents, ambiguous documents, out of date procedures, and memory based entries. To minimize the risk of costly mistakes, processes, procedures and systems should be in place to detect and prevent these errors..

[Audio] Data integrity is essential for the functioning of any system, and this document provides guidelines for good documentation practices and data integrity quality assurance in the year 2023. These guidelines are designed to provide a comprehensive and easy to understand approach for ensuring that accurate and consistent data is maintained from its gathering to its storage. Breaches of integrity should be addressed promptly when they occur during manufacturing and testing, inspection and post inspection. Following these guidelines allows us to ensure that our data is accurate, trustworthy and reliable, and remains so throughout its life cycle..

[Audio] In 2023, data integrity is essential for quality assurance. Inadequate training, unawareness, lack of knowledge, misguided guidance, outdated SOPs, insufficient personnel, guessing and estimations, and unreliable equipment and facilities can lead to data integrity failures. To guarantee quality standards, organizations need to provide comprehensive training to personnel and use reliable equipment and facilities. Additionally, organizations must keep up with the most current SOPs and set up quality assurance directives..

[Audio] To ensure data accuracy and reliability, organizations must take precautions to protect it from alteration, falsification, overwriting, incorrect entries, password sharing, confidential data sharing, backdating, post-dating, data duplication, data regeneration, and data compromise. Adherence to these data integrity rules will ensure that data remains secure and compliant with industry standards..

[Audio] Attention to data integrity is essential for any company to retain its competitive edge. Poor data integrity can have disastrous repercussions for an organization, such as damaging its reputation, eroding customer trust, demoralizing employees and undermining future business plans. These issues can be circumvented with stringent documentation practices and quality assurance..

[Audio] Data integrity (DI) is a key component of any successful data governance strategy. An intentional data culture within the organization that promotes understanding of the importance of accurate and reliable data is essential. A strong data quality system with regulations and procedures to guarantee the accuracy of data should be instituted. Employees need to be made aware of the importance of DI and receive ongoing training to handle data correctly. Otherwise, the organization may experience loss of knowledge or misinterpretation of data, resulting in suboptimal practices and a breakdown in data governance..

[Audio] Businesses' dependence on data and technology has made it more important than ever to guarantee accuracy and integrity of their data. Neglecting to do so can cause serious and costly problems. Time constraints can lead to cutting corners, and a lack of comprehension may serve to exacerbate the issue. Performance pressure, instructions from a superior, and sometimes even money or cultural factors can also increase the risk of data integrity issues. Organizations must take preventative measures and maintain the highest standards of data integrity quality assurance..

[Audio] As we move into the year 2023, it is essential for businesses to have effective documentation practices and data integrity quality assurance for success. This document provides best practices for meeting these objectives. Adhering to these guidelines will guarantee the accuracy and security of data, while at the same time streamlining workflows, allowing tasks and projects to be completed on schedule. Putting into practice the instructions of this document will help businesses remain competitive in a constantly evolving digital environment..

[Audio] To ensure the accuracy and reliability of data, it is important to adhere to rules regarding data integrity quality assurance. To maintain data integrity, it is recommended to avoid typing results, applying fluid to correct mistakes, using obsolete documents, using pages and sheets which have faded or been inadequately photocopied, leaving any empty result boxes, using single lines in lieu of a signature in each column and row of a document, opting for a stamped signature instead of a handwritten one, using pencils which can be erased, and forgetting to initial and date results for each line..

[Audio] Good documentation practices and data integrity quality assurance are an essential part of any successful business in the year 2023. The importance of these practices should not be underestimated. We must remember some simple don'ts when we are working; do not report results as "as expected" or conforms; do not use ditto marks; do not start work until a permit is issued; do not update the labels on instruments without calibration performed; do not fill raw data prior to an activity; do not share confidential information outside the premises; do not keep unauthorized documents; do not perform an activity without training; and all entries must be done on a real-time basis with no backdating allowed. Finally, ensure that the master instrument is calibrated before using it for activity..

[Audio] Providing guidance for good documentation practices and data integrity quality assurance in the year 2023, cross out any mistakes with a single line and use 'C L I D E' method for correction of errors or mistakes. Put on sign with date when any task has been done, use blue ink (ballpoint pens) for entry in GMP documentations and check (4 eyes principle) for critical steps. Turning attention to the New York City Ballet, a world-renowned dance company dedicated to classical ballet..

[Audio] This document outlines the necessary steps to achieve data integrity and sound documentation practices by 2023. A table below provides key areas of focus, such as falsification or fabrication of records, computer access controls, and unexplained data discrepancies. Organizations must take measures to address these points and ensure that their systems meet the highest standards for data integrity and quality assurance..

[Audio] Record-keeping and data storage are essential to any industry. To stay in compliance with Good Manufacturing Practices in 2023, records and documents related to product manufacture must remain intact and secure. It is important that mistakes are kept for traceability and all paperwork and notes must be controlled, organized, and secure. These are critical guidelines that must be followed for product safety and the welfare of all involved. Good data integrity and documentation are essential for success in any sector, including 2023..

[Audio] Documentation practices and data integrity are essential for guaranteeing the quality of pharmaceuticals now and in the future. This document provides guidance on how to sustain quality documentation and data integrity. It includes ICS/QA/003/00, EudraLex Volume 4, Quality Assurance of Pharmaceuticals Volume 2, and ISO 9001 5th edition 2015, and serves as an informative handbook for those exploring for industry-authorized directives..

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