Follow the process documentation steps we have discussed above, and make use of the process flowchart templates to ensure a quality documentation process. If your document says what actions took place in the. Welcome to the national institutes of health, office of intramural training and educations webinar on keeping a. To ensure that all personnel know what to do and when to do it, c. Current good manufacturing practices cgmps help to establish the foundation for quality pharmaceuticals through regulatory standards. This webinar will cover the basics of what good documentation practices include, along with examples of practices not acceptable to auditors. Good documentation practices ann glasse, rn, bsn, mba. Why are good documentation practices so important to our customers. Whether you are mapping your infrastructure, drafting server and application dependencies or preparing for a software audit, the best time to begin the process is well before you need it. Good documentation practice by arif roslan on prezi. Coming across ur program online was the best thing i have done, knowing that all my thoughts. Your program has taken my snoring down to a low hum.
Which are the following is good documentation practices a date and time specific entries when medications are. Also, find out if your company qualifies for 100% grant funding for this openenrollment or inhouse course. Good documentation practice one of the way to be excellent by. Documentation practice has been changing since 2000, when some key opensource project groups including the linux kernel project, gnome, kde, the free software foundation, and the linux documentation project agreed on an approach more webfriendly than traditional unixs printoriented tools. Gdps are enforced by regulatory agencies such as the fda, tga, emea, health canada or who. The examples i show are examples of what makes great end user documentation. Pdf the effective control and management of documentation is a critical part of the gmp program within the organization. To define the specifications and procedures for all materials and methods of manufacture and control, b. Thank you for your interest in good documentation practices. The original data file should be protected from modifications. The importance of good documentation practice needs to be emphasized to.
Good documentation practices general rules youtube. Good documentation practice one of the way to be excellent. This process documentation guide covers everything you need to know to document a process properly. Good documentation practices gdocp gmp basics pharmout. Your presentation to this customer needs to focus on the demonstrable features of your paas, while the document just helps to remind customers about the value of your platform. Documentation practices in research, the only thing that remains to attest to our efforts is the documentation.
Requirements for good documentation practice gdp learn all about the good documentation practice including basics, gmp document preparation, issuance and retrieval of records, recording of time, correction of entries, handling of missing entries, blank space and cancellation of gmp records. To lay down the procedure for good documentation practices in facility. Software isnt a tangible good like that fancy watch or smartphone. Why are good documentation practices so important to our. Ive downloaded your program because my dad has been suffering from. Some tips on good documentation practices concise, legible, accurate and traceable picture is worth a thousand words clear examples dont assume knowledge some tips on good documentation practices records should be completed at time of activity or when any action is taken. Create database software based or manual system to. Documentation that is used in support of manufacturing, laboratory and clinical practices should adhere to gdp. The content of this presentation is for reference only and should not in anyway be used in place of your company gdp policy. Good documentation constitutes an essential part of the quality assurance system.
One of the most common inspection findings in investigator site inspections is lack of reliable, accurate and adequate source documentation. Sop on good documentation practices pharmaceutical guidance. To incorporate a robust quality system encompassing good documentation practices, including but not limited to. Ultimately, your documentation isnt going to improve if it isnt being managed. Training checklist good documentation practice gdocp. Good documentation and quality management principles vimal sachdeva technical officer inspector, who prequalification of. Gdp good documentation practices quality support group. This presentation will cover all aspects of gdp as per the proposal in the proposed.
As per the who 7, the purpose of good documentation practices is a. You will be shown the benefits of good documentation practices in the gmp environment you will gain a knowledge base for controlling and handling documents in a gmp compliant environment you will have a better understand the basic requirements that fda seeks for all records, documents, forms and procedures to meet gmp requirements. In this article i am trying to put together some important aspects of good documentation practices and how they could be useful to avoid the form 483 citations and or warning letters. Facts about the current good manufacturing practices. Users dont want documentation, they want answers is a wellknown phrase in the documentation profession. An ebook reader can be a software application for use on a computer such as microsofts free reader application, or a booksized computer this is used solely as a reading device such as nuvomedias rocket ebook. Good documentation practice gdp rightfirsttime approach for the document is gdp to ensure identity, authenticity and accuracy of records. Using these tools and techniques will save you time, and will give you the confidence that good documentation practices are taking place. This is a build and presentation issue for documentation, but being able to add some level of semantic markup to. To show expert users of windows all the screens that appear during the installation of your product is not necessary. To ensure that authorized persons have all information. And when it comes to technical documentation, one of the best ways to frame it is as what jason freedman calls 3090 feedback. The products explain good documentation expectations and using dental software as a tool for good documentation practices.
Good documentation practices gdps we can assist you to establish the needed standard operating procedures and all other documents pertaining to good manufacturing practices and good clinical practices our documents were written according to the. A computerized system consists of hardware, software and network components which. This also happens to be the most common pitfall identified during sponsor audits. Good documentation practice commonly abbreviated gdp, recommended to abbreviate as gdocp to distinguish from good distribution practice also abbreviated gdp is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. Contact us for more information and training dates regarding this course and a qsg representative will call you as soon as possible. Good documentation practices gdps in pharmaceutical. Technical documentation is meant to teach somebody everything there is to know about a subject, whereas end user documentation is meant to just show somebody the necessary steps to accomplish a task and answer how to. Documentation is the most valuable thing you do system. Good documentation makes software and tools more valuable and more durable, and although documentation can be a great expense, in the long term its almost always worthwhile. How to implement good documentation practices pharmout. The lack of such good documentation practices are routinely cited in fda 483 observations. We look at best practices for creating it documentation. Good documentation practice and record keeping regulations. This standard operating procedure is applicable to all departments involved in documentation activities throughout the facility of pharmaceutical company name.
Learn vocabulary, terms, and more with flashcards, games, and other study tools. Good documentation practices gdp is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified. Attend this webinar to learn proper methods for documenting data in the highly regulated pharmaceutical industries. Good documentation practices free download as powerpoint presentation. Good documentation practice is an expected practice. Basics of good documentation practices gdocp and the difference between gdocp and gdp in the pharmaceutical industry, medical device. Such measures that collectively and individually ensure documentation, whether paper or electronic, is attributable, legible, traceable, permanent, contemporaneously recorded, original and accurate. Compliance with the food and drug administrations glp, or good laboratory practices, regulations 21 cfr part 58, as well as gmp regulations for drugs and medical devices 21 cfr part s 211 and 820 requires the use of good documentation practices.
Main reason for that is the expert or individual who is responsible would like to write or give a checklist as per his or her knowledge. Scribd is the worlds largest social reading and publishing site. In this course on good documentation practices for the life sciences you will learn all about the basics of working with documents in a regulated environment. Good documentation practices are expected to assure they are accurate, legible and traceable to name a few. Remote work advice from the largest allremote company. Good documentation practice commonly abbreviated gdp, recommended to. Some tips on good documentation practices records should be completed at time of activity or when any. This webinar will highlight how the use of gdp allows companies to comply with regulatory requirements such as good laboratory practices glp, good manufacturing practices gmp or the applicable quality management system for. Keeping a lab notebook national institutes of health. Good documentation practice gdp routinely used within the. Keeping a lab notebook basic principles and best practices philip ryan, phd scientific program analyst office of intramural training and education. Feedback on the easy guide to process documentation. This white paper describes the fundamental requirements of good documentation practice gdp routinely used within the pharmaceutical industry as best practice standards or as a direct requirement of the code of good manufacturing practice gmp. Training is the biggest source to plug in mistakes in industry and biggest source of errors too.
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