Tag Archives: documentation
Book Review of “Eliminating the Gobbledygook” by Kathy Walsh
As one with a love for documentation and trying to communicate effectively and concisely, I bought a copy of Eliminating the Gobbledygook – Secrets to Writing Plain Language Procedures by Kathy Walsh. I am pretty sure I worked alongside Kathy some years back on what was called the Documentation Effectiveness Project at Mayne so I was not expecting too many surprises as we both know our stuff. The purpose of the book purchase was to refresh and update my knowledge of controlled document writing. I figured I may as well review the book in the process. Continue reading
What is Data Trending and How To Identify, Action and Report Trends
The following is an article I placed on LinkedIn and was written as part of my Developing My Writing While Helping Others series.
Paul Yeatman is a microbiologist with over 15 years’ experience in documentation, validation and running investigations in TGA and FDA regulated environments. He has a strong interest in process improvement, documentation, training and developing others. From 9-5 Paul investigates and solves software problems. By night he works on his science chops. He has an arty streak, runs several blogs and enjoys communicating his experiences and knowledge in arenas such as this. Continue reading
Controlled Documentation. Identifying what goes into a Policy, a SOP and an OI
The following is an article I placed on LinkedIn and was written as part of my Developing My Writing While Helping Others series.
I am a microbiologist with over 15 years’ experience in the pharmaceutical realm. I have a strong interest in regulatory compliance, documentation and developing others. Recently I have been working closely with data security. I have an arty streak, have developed and delivered training and have an affinity for computers. I ride bicycles…a lot.
Controlled Documentation. Identifying what goes into a Policy, a SOP and an OI Continue reading
Question Regarding Purified water used for Equipment washing and Manufacturing of Oral solids
The Question posed on LinkedIn:
“What should be the temperature for Purified water used for Equipment washing and Manufacturing of Oral solids? Should it be 60-80C or it can be used at 22C with circulation of water? Need references“
What are the guidelines for autoclave re-Validation?
The Question posed on LinkedIn:
“Dear Experts, What are the guidelines that clarify the frequency and number of cycles required for re-Validation of equipment? For example, during re-qualification of the autoclave should each cycle be repeated 3 times (empty, minimum and maximum loads)? Or is it based on risk assessment by choosing the maximum loads only? (On initial qualification each cycle was performed 3 times consecutively). Also for depyrogenation tunnels, should the runs be repeated 3 times? Thank you“
Question regarding classification of passthroughs and laminar flow hoods
The Question posed on LinkedIn:
“Can we provide the grades of pass box and lafs in on critical area with respect to material movement ? For example if a pass box installed between grade c and grade d environment can be designated as grade b? Similarly laf installed in grade c area can be designated as grade c? If yes what woukd be the viable and non viable limits to be applied?“
Ability to manage the release of the software/device exactly with the support mechanisms
The Question posed on LinkedIn:
“I have been working with an academic team of global R & D partners on TECH DOC, Product Support, Training, and Learning/Development solutions. One item on the hot list is the ability to manage the release of the software/device exactly with the support mechanisms such as the KB, the release notes, and the manual/quick start guide. Across several sectors, this issue seems to exist. How do I save the most time, yet not overwork the team, and remain as precise as possible without creating confusion for the internal teams/external teams? Any product manager, project managers, or other TECH DOC specialists care to share how to provide precision across the different LOBs in a global environment where time zones matter?“
Review of Draft Standard: AS 2828.2 Health records, Part 2: Digitized health records
One way I keep myself up to date with developments within laboratories and related areas is by reviewing draft standards. This keeps me appraised of the current state of affairs, keeps my documentation audit skills fresh and potentially allows me to contribute to the content of standards. For this draft standard, I have some knowledge of IT and IT security so am able to critically review the draft standard and offer comment.
Notes: refer to the conditions for comment stated towards the beginning of the draft standard.
DR AS 2828.2 Health records, Part 2: Digitized health records Continue reading
Review of Draft Standard: AS 2243.2 Safety In Laboratories – Part 2: Chemical Aspects
One way I keep myself up to date with developments within laboratories and related areas is by reviewing draft standards. This keeps me appraised of the current state of affairs, keeps my documentation audit skills fresh and potentially allows me to contribute to the content of standards.
Notes: refer to the conditions for comment stated towards the beginning of the draft standard.
Update 20190103: After proceeding to submit comments, I observed page numbers were required. That is important to note for future reviews. Page numbers added.
DR AS 2243.1 Safety In Laboratories – Part 2: Chemical Aspects Continue reading