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.

DR AS 2243.1 Safety In Laboratories – Part 2: Chemical Aspects Continue reading

Review of Draft Standard: AS 2243.1 Safety In Laboratories – Planning and Operational 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.

Here I step through the draft standard making comments.  Where a comment is answered later in the standard, I go back to my original comment and make notes.  An uncommented comment is potentially worthy of becoming an official comment on the standard.

Section 1 Continue reading

IMM3022 Immunocytochemical and Lectin Labelling of Acid Secreting Cells in the Stomach and Kidney

IMM3022 Immunocytochemical and Lectin Labelling of Acid Secreting Cells in the Stomach and Kidney

Paul Yeatman

Partner/s: Rachael Davies, Tanya De Jong, AnnalieseSampey, Adreana Lambrinakos, Anna Rentoulis, Steve Argirio, Spiros Foscolos.

Date: 24th August -> 5th October 1994.

Introduction

Certain organs in the body contain cells, which are involved in acid secretion. In the stomach such cells are called parietal cells and exist in gastric pits contained in the stomach body. (Diagram.1 and Diagram.2). In the kidney such cells are known as intercalated cells, and line the collecting ducts of the kidney. (Diagram.3 and Diagram.4) In both cases, a two-subunit ATP dependent (ATPase) proton pump controls the acid secretion. Continue reading

Does anyone use Evernote as an ELN (electronic laboratory notebook)?

The Question posed on LinkedIn:

Does anyone use Evernote as an ELN (electronic laboratory notebook)?

Evernote seems to be a powerful, extensible cloud based application. I am curious if anyone in the group uses it in their lab and how do they use it, for what purpose and how well does it work for your needs?/

My reply to this was:

I’d not advise it. Besides a vendor audit to ensure availability of the system and backups you’d need to ensure Evernote data cannot be obscured or changed, make sure time, date and user stamps are in place and the data integrity is maintained for the duration of the retention period.

 

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Developing a Quality Management System

Why would anyone want a Quality Management System, or QMS?  To quote the ISO, “It helps businesses and organisations be more efficient and improve customer satisfaction.”  The document that details such a system is ISO 9001 (2015) Quality Management Systems.  A large part of this ISO reads as a business plan – improve performance; sustainable development; identify opportunities / enhance customer satisfaction etc.  Overall, the ISO employs the approach of Plan-Do-Check-Act and requires risk-based thinking. Continue reading

Policy vs Standard Operating Proceedure vs Operator Instruction

What follows will form part of a post tentatively titled “GMP Technical Writing”. The larger post will incorporate aspects of Writing Technical Reports and The Need for Documentation and detail the hierarchy of documents within a Quality Management System, what information goes where and how to conduct buisiness process mapping. I’m tossing up on whether to present this as a series of posts or as some sort of presentation style document (pdf or Powerpoint).

A Policy A SOP An OI
What’s What  Course of action adopted due to one or more considerations such as legal or regulatory requirements

Contains regulatory, corporate or scientific policies, rules or principles.  Explains why these are considerations.

generally affect multiple SOPs.  If affects one SOP, should include detail in SOP after Additional Information section.

  • If information >1 page and affects >1 SOP
  • or >3 pages and affects 1 SOP, write a separate policy document
  • Who, what, when where and why.
  • A series of stages describing the sequence of tasks performed
  • Describes processes lasting an extended time (hours, days, weeks).
  • Tends to encompass multiple users.
  • Written with the overall goal of achieving the outcome via a number of specified outcomes.

Each stage in a SOP comprises a number of action or steps. Length dictates their placement in a SOP or an OI:

  • ≤4 steps -SOP content.
  • >4 steps – place in an OI.
  • How to do something.
  • Step wise instructions.
  • Takes place in the now.
  • Tends to involve single user.
  • Written to achieve a specified outcome.
Tables  Informational
  • Overview only – Section/Description.
  • Stage/Description.
Step/Action
Flow Charts  Informational

Must not exceed 1 page.

Used a process overview.

  • If ≥5 sections, a flow chart can be used.
  • If <5 sections, a Section/Description table use used.
  • Must not exceed 1 page.
  • Suitable only where instructions are straightforward.
  • Must not exceed 1 page.
Naming Convention  N/A Use present continuous. eg. Sampling of Water for Injection
!!”ing” in the title.
Use the present simple. Daily Check of Equipment Calibration
!!If the proposed title includes “How to…” the it’s likely an OI.
In General
  • Section headings do not include full stops
  • For all nouns and verbs in document titles, use capitals. Does not apply to section headings.

-Title: Using The Autoclave
-Section Heading: Load the autoclave

  • Be consistent in the use of bullets and font.
  • Be consistent with capitalisation and use of punctuation.
  • Read your work out loud. If you stumble, the reader will too.
  • Plan. Talk to SME’s. Before you begin writing, identify the information type(s).
  • Chunk the information 7±2

Notes on the FDA’s Draft Data Integrity and Compliance With CGMP Guidance for Industry

Having worked in the pharmaceutical industry where I’ve dealt with electronic systems, paper based systems, programmed my own access databases and Excel spreadsheet  and been on projects such as LIMS system validation, I figured I’d make notes on the FDA’s 2016 guidance for industry document regarding Data Integrity and Compliance With CGMP.  This draft is for currently open for comment and the guidance addresses data integrity in:

  • drug manufacture
  • finished pharmaceuticals
  • positron emission tomography drugs

Continue reading