Technical Writing: Best Practices
After obtaining a B.S. and an M.S. in Chemistry from Tuskegee University, Robert Peoples joined the pharmaceutical industry as a Research Chemist with a concentration in analytical chemistry at Wyeth/Lederle. While at Wyeth/Lederle Robert was primarily responsible for the analysis of the Active Pharmaceutical Ingredient (API) in various drug delivery formulations, e.g. aerosols, capsules, creams, ointments, and tablets. He joined Organon/Merck as a Research Chemist responsible for the development of stability-indicating methods of analysis using HPLC.
While at Organon/Merck, Robert transitioned into technical writing. As a Technical Writer, he was responsible for the creation of procedures for instrument qualification, test scripts, IQ/OQ/PQ protocols for sample handling, cleaning validation reports, method transfer reports, method validation reports, stability reports, Change Control and CAPAs. Later he joined Johnson and Johnson as a Technical Writer where he created stability strategies, protocols, and reports as well as SOPs developed training materials and competency profiles in addition to proofreading and improving written reports for other departments. He also edited policies and procedures, user guides, and job aids.
After leaving Johnson and Johnson Robert became a consultant to other pharmaceutical companies where he created SOPs for analytical method validation as well as pharmaceutical stability studies and stability program management. For another client company, he created stability reports that addressed FDA concerns about OOS/OOT results. For yet another client company he created stability reports, protocols and strategies for medical devices. He also created written assessments for software-controlled laboratory instrumentation.
Robert also has extensive experience in data review, stability management, and training.
Technical Writing generally conforms to Good Documentation Practices (GDocP). This term describes standards to create and maintain documents. The term is primarily associated with the pharmaceutical and medical devices industries but applies to documents created in multiple organizations. Most companies have in-house requirements that all documents produced within the organizations conform to the firms’ particular requirements. The purpose of the webinar is to define and clarify general guidelines for the creation and maintenance of documents in order to ensure consistency between documents created by various functional groups within organizations.
It is vitally important that each organization has policies and/or procedures that reflect the use of Good Documentation Practices within the organization. Examples of the use of Good Documentation Practices are the creation of formal documents (also known as reports) and Standard Operating Procedures also called SOPs. Other examples of documents created using Good Documentation Practices are Work Instructions, Laboratory Procedures, Computer Validation Test Scripts, Training and Qualification Records, Requests for Grants from other organizations, Customer Service requests, Customer Complaints, and even Market Research Questions. Good Documentation Practices are important to newspapers, magazines, and television stations as well as local, state, and federal governments. All documents created within organizations must conform to Good Documentation Practices.
Documentation must be permanent so that it cannot be changed without evidence that a change has occurred. An example of the documentation of changes is an audit trail. An audit trail documents all changes in a validated system with time and date stamps. Any changes, additions, or items removed from systems are immediately obvious to the casual observer.
Much of, if not the majority of technical writing takes the form of reports and Standard Operation Procedures. Documentation in reports and Standard Operation Procedures must be permanent. Any changes in documents must be obvious to the casual observer.
Reports and Standard Operation Procedures are reviewed and approved by personnel who did not perform the tasks but who are familiar with the work done. Reports and Standard Operation Procedures are often peer-reviewed and dated followed by supervisory review and approval. The purpose of review and approval is to ensure that the information provided is correct and accurate. The purpose of dating the review and approval is to provide timelines for documentation and possible investigation.
Generally speaking, the Best Practices of Technical Writing are to be addressed by in-house policies and procedures in accordance with Good Documentation Practices. Good Document Practices require that documents must never be recorded on Post-it notes, scrap paper, unapproved notebooks, or any document that is not controlled. This requirement is true even if the intent is to later post the documents into approved notebooks or equivalent. Pencils or erasable ink must never be used. Records are permanent and must be posted in permanent places whenever they are generated. Similarly, documentation must never be destroyed or amended because such practices suggest fraudulent results.
Good Documentation Practices require that a single line is drawn through errors such that the original records show. The corrections are initialed and dated with an explanation as to why the corrections were made. If space is limited and there is no room for initials, dates, and explanations numbers may be used as footnotes to explain the changes. The footnote numbers reference the corrections made in the text. They are consecutively numbered and generally appear at the bottom of the page of the corrected text. If organizational policies and procedures permit correction numbers may be placed within indexes to reports or Standard Operation Procedures.
There are 5 points to remember about the best practices of technical writing:
- Technical writing must be legible
- Technical writing must be permanent
- Technical writing must be countersigned
- Technical writing source material must be referenced
- Always follow in-house policies and procedures
- Basics of Technical Writing Best Practices
- Technical Writing Best Practices General Requirements
- Technical Writing Best Practices for Violations
- Technical Writing Best Practices for Corrections
- Technical Writing Best Practices the Treatment of Numbers
- Technical Writing Best Practices for Reference to Source Materials
Who Should Attend
- IT Staff/Management
- Scientific Staff
- Human Resources: Staff/Management
- Any highly specialized company personnel
Why Should You Attend
Attendees need to know the best practices of Technical Writing. They need to understand the concepts of Technical Writing in order to address the situation below.
You have been given what can be a daunting task to write a report on work that you or someone else has done, a Standard Operating Procedure (SOP), an Instruction Manual for the operation of some instrumentation for training the general public or in-house personnel, a Laboratory Procedure, a manual to explain the use of a new service for the general public. Technical Writing could also involve reporting on work for inclusion in an FDA filing, the justification for the purchase of new instrumentation, an increase in the operating budget for a department, or any number of written presentations. You are quite comfortable in your area of expertise and often excel in that area. Far too often your area of expertise does not include writing and this takes you out of your comfort zone. You stare at a blank screen while realizing that you have to create something! What to do? This webinar is designed to answer that question.
Technical writing must be balanced enough such that the highly technical audience will understand and appreciate what is said but Technical Writing must also be understood by an audience who may not be as well-versed in the subject matter as other members of the audience. Usually, Technical Writing consists of reports and/or Standard Operation Procedures but can also include Instruction Manuals or any written presentation for a highly specialized audience.
Your first consideration: Who is the audience? Who will read the document? Why will they read the document? How long will they have to read the document? Are they interested in the document? How do I arouse interest in the document? There are so many other questions that you can ask but these are the types of things that you should consider.
The next consideration is what are you trying to tell the audience? What are the ideas/the concepts/the concerns do you want to convey to the audience?
Your next consideration: How to pass along those ideas/concepts/concerns to the audience. Do you simply give directions, like in Standard Operation Procedures or Instruction Manuals? How much does the audience know about the subject matter? Is the audience familiar with the subject matter at all? How familiar are they? The audience may not be familiar with the subject at all or they may be better informed than you are in the subject matter.
Attendees need to know the best practices of Technical Writing in order to produce reports and Standard Operation Procedures. They need to how to do corrections, locate source materials, learn and master in-house practices and so many other things in order to produce quality documents.
These and other concepts will be discussed in the webinar.