Good documentation practices presentation software

Keeping a lab notebook basic principles and best practices philip ryan, phd scientific program analyst office of intramural training and education. Training is the biggest source to plug in mistakes in industry and biggest source of errors too. Good documentation practices ann glasse, rn, bsn, mba. Good documentation practice and record keeping regulations. This presentation will cover all aspects of gdp as per the proposal in the proposed. Scribd is the worlds largest social reading and publishing site. An overview of good documentation practices applicable to those working in the pharmaceutical and healthcare sectors is presented. Create database software based or manual system to. Gdp good documentation practices quality support group. 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. 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. Sop on good documentation practices pharmaceutical guidance. Welcome to the national institutes of health, office of intramural training and educations webinar on keeping a.

This is a build and presentation issue for documentation, but being able to add some level of semantic markup to. Good documentation practices are expected to assure they are accurate, legible and traceable to name a few. Good documentation practice gdp rightfirsttime approach for the document is gdp to ensure identity, authenticity and accuracy of records. Facts about the current good manufacturing practices. Good documentation practices gdps in pharmaceutical. Thank you for your interest in good documentation practices. Good documentation answers the questions that people ask. Such measures that collectively and individually ensure documentation, whether paper or electronic, is attributable, legible, traceable, permanent, contemporaneously recorded, original and accurate. Some tips on good documentation practices records should be completed at time of activity or when any. 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. 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. Pdf the effective control and management of documentation is a critical part of the gmp program within the organization. Ive downloaded your program because my dad has been suffering from. Remote work advice from the largest allremote company. 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. 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. Software isnt a tangible good like that fancy watch or smartphone. This standard operating procedure is applicable to all departments involved in documentation activities throughout the facility of pharmaceutical company name. Why are good documentation practices so important to our. Training checklist good documentation practice gdocp. Which are the following is good documentation practices a date and time specific entries when medications are. To incorporate a robust quality system encompassing good documentation practices, including but not limited to. Good documentation practice gdp routinely used within the.

Good documentation constitutes an essential part of the quality assurance 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. Good documentation practice one of the way to be excellent by. 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. How to implement good documentation practices pharmout. Contact us for more information and training dates regarding this course and a qsg representative will call you as soon as possible. Acronym for the group of good practice guides governing the preclinical, clinical, manufacturing. This process documentation guide covers everything you need to know to document a process properly. If your document says what actions took place in the. Current good manufacturing practices cgmps help to establish the foundation for quality pharmaceuticals through regulatory standards. The lack of such good documentation practices are routinely cited in fda 483 observations. A computerized system consists of hardware, software and network components which.

Documentation practices in research, the only thing that remains to attest to our efforts is the documentation. To define the specifications and procedures for all materials and methods of manufacture and control, b. Also, find out if your company qualifies for 100% grant funding for this openenrollment or inhouse course. Your program has taken my snoring down to a low hum. Using these tools and techniques will save you time, and will give you the confidence that good documentation practices are taking place. Good documentation practices free download as powerpoint presentation. 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. Good documentation practice one of the way to be excellent.

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. To show expert users of windows all the screens that appear during the installation of your product is not necessary. To lay down the procedure for good documentation practices in facility. Ultimately, your documentation isnt going to improve if it isnt being managed. Documentation that is used in support of manufacturing, laboratory and clinical practices should adhere to gdp. 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 commonly abbreviated gdp, recommended to. 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. 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.

This webinar will cover the basics of what good documentation practices include, along with examples of practices not acceptable to auditors. Why are good documentation practices so important to our customers. 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. 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. Good documentation and quality management principles vimal sachdeva technical officer inspector, who prequalification of. Learn vocabulary, terms, and more with flashcards, games, and other study tools. Basics of good documentation practices gdocp and the difference between gdocp and gdp in the pharmaceutical industry, medical device. Follow the process documentation steps we have discussed above, and make use of the process flowchart templates to ensure a quality documentation process. This also happens to be the most common pitfall identified during sponsor audits. Good documentation practices gdocp gmp basics pharmout. To ensure that authorized persons have all information. The importance of good documentation practice needs to be emphasized to. Coming across ur program online was the best thing i have done, knowing that all my thoughts. Documentation is the most valuable thing you do system.

The content of this presentation is for reference only and should not in anyway be used in place of your company gdp policy. 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. Good documentation practices general rules youtube. 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. Good documentation practice is an expected practice. And when it comes to technical documentation, one of the best ways to frame it is as what jason freedman calls 3090 feedback. Keeping a lab notebook national institutes of health.