In my nearly 20 years as a technical writer for pharmaceutical and biotechnology business, I’ve frequently been asked how writing for these industries differs from other industries.
” Really? What the heck type of writing do you provide for them?” they ask.
In this post, we’ll dive into that extremely concern. The answer is a bit more intricate than you might think.
Distinction # 1: Think SOPs Not User Guides
Prior to my time in biotech, I spent the previous decade and half working for Fortune 1000 companies (GE, Blue Cross Blue Shield, Liberty Mutual), small software application startups (Digital Delivery, OpenSite Technologies), and I even did a stint in greater ed (MIT).
As a technical writer for these organizations, I was mostly responsible for recording detailed guidelines for various systems, software application applications, and processes. Typically, these directions would enter into some type of a user guide, such as a User Manual, Installation Guide, Troubleshooting Guide, etc
. Pharma and BioTech business are different in that the primary deliverable is generally some form of a standard operating procedure or SOP.
Depending upon who you ask, you will get a lots of various responses on the meaning of an SOP. Simply Google “definition of an SOP” and you’ll get a sense.
Merriam Webster does a decent job of defining an SOP in general terms:
” Established or prescribed methods to be followed routinely for the efficiency of designated operations or in designated scenarios.”
The IOSR Journal of Pharmacy provides a more appropriate definition for pharma and biotech in my view:
” A Standard Operating Procedure (SOP) is a set of composed instructions that document a regular or recurring activity that is followed by employees in a company. The development and use of SOPs are an important part of an effective quality system. It supplies info to carry out a job correctly, and consistently in order to achieve pre-determined requirements and quality end-result. SOPs must permit the continual enhancement of standards of service, and provide evidence of dedication towards safeguarding patients. Additional benefits are:
· Help to assure quality and consistency of service;
· Help to make sure that great practice is achieved at all times;
· Provide a chance to totally utilize the competence of all staff member;
· Help to avoid confusion over who does what (role information);.
· Provide suggestions and guidance to locums and part-time personnel;.
· They work tools for training new members of personnel;.
· Provide a contribution to the audit process.”.
Biopharma SOPs vary widely in size depending upon the complexity of the system or procedure being recorded. I’ve dealt with some three-page SOPs, and I’ve dealt with some that were over 300 pages.
SOPs generally consist of the following significant areas at a minimum:.
· Purpose.
· Scope.
· Definition.
· Procedure/ Operations.
· References.
· Attachments or Appendices.
The meat of the SOP remains in the Procedure/ Operations section. This is where the detailed instructions are documented.
A Parenteral Drug Association (PDA) study discovered that a typical pharmaceutical company must, typically, manage a whopping 1250 SOPs with the typical upkeep burden at 15,000 hours.
One last note on SOPs, these are by no means “elegant” documents. And technical authors have really little creative license with them. They are typically written in Microsoft Word, have no cover page, really little format, and are in Times or Times New Roman typeface.
Distinction # 2: Good Quality Practices (GxP) Rule the Roost.
GxP means ‘great practice’ quality guidelines and policies. The purpose of the GxP quality standards is to ensure an item is safe and fulfills its designated usage.
The little x in the acronym is used to signify the numerous fields of governance.
For instance, GMP standards for Good Manufacturing Practice, GLP represents Good Laboratory Practice, and GDP stands for Good Documentation Practice. Have a look at this Wikipedia page if you wish to see extra examples of GxP standards (there are a number of).
Most GxP practices offer some level of governance around documents and some, like GDP, supply governance across numerous practices. For instance, if you work in a laboratory (and need to follow GLP), your SOPs need to also comply with GDP.
Confused yet?
The bottom line is that in the highly controlled Pharma and BioTech industries, there are numerous practices and requirements than need to be followed. If business differ the requirements, they can be provided hefty charges and even fines from the FDA and other controling authorities. Even even worse, potentially life-saving products can be delayed in getting to market or perhaps shelved for good.
Distinction # 2: Tons of Project Documentation.
In order to satisfy FDA and other regulative requirements, all internal jobs require a load of documentation to guarantee that biopharma systems and tasks depend on snuff. This is especially true for IT Systems, many of which need to follow some kind of the Systems Development Lifecycle (SDLC). Wikipedia does a great task of defining SDLC:.
” The systems development life process (SDLC), also referred to as the application advancement life-cycle, is a term utilized in systems engineering, information systems, and software engineering to explain a process for planning, creating, screening, and deploying a details system.”.
To offer you a sense of the scope, below is a partial list of the types of documents that might be required to execute a GxP-compliant IT system in a lab. For example, this could be a lab information management system (LIMs) that gathers data from drug discovery experiments.
Note: The particular requirements and real deliverables depend on system complexity and internal quality requirements and processes.
· Project Charter.
· Business Case.
· Cost-Benefit Analysis.
· Project Resource Plan.
· Statement of Work.
· Risk Analysis.
· Procurement Plan.
· Roles and Responsibilities Matrix.
· Work Breakdown Structure Resource Planning Template.
· Project Plan.
· System Impact Assessment.
· Business Requirements Document.
· Functional Requirements Document.
· Software Architecture Plan.
· Use Case Template.
· Requirements Traceability Matrix.
· Service Level Agreement Template.
· System Design Specification.
· Database Design Document.
· Data Migration Plan (for an upgrade to a brand-new system).
· Test Plan.
· Test Scripts (there could be lots and even numerous these! ).
· Testing Bug Report.
· Testing Bug List.
· Project Acceptance Document.
· Change Management Log.
· Project Status Report.
· Production Implementation Plan.
· Production Turnover Approval.
· Disaster Recovery Plan.
· Global Application Support Summary.
· Developer Knowledge Transfer Report.
· System-Level Standard Operating Procedure.
Once again, this is a partial list. The list of documents is in fact twice this size! For the long list of SDLC artifacts, see the SDLC Forms site.
So, as you can see, there is quite a bit to the SDLC– and no lack of opportunities for technical authors to end up being involved in the procedure. Regretfully, a problem typically dealt with by IT task managers is a lack of resources to help preserve the quality and consistency of SDLC files. As a result, they end up doing the work themselves or delegating to a member of the task group. Because each project team member’s composing skills and data processing abilities vary, this can present some major challenges to total quality.
Excellent design templates can assist, but those organizations that are dedicated to quality SDLC deliverables should insist on including technical authors in their tasks.
Difference # 4: Quality Oversight.
The 4th key difference is quality oversight.
While any company with a dedication to quality will have some type of QA process in place, the internal governance for biopharma is a lot more stringent and stiff than in other industries.
Of course, strict adherence to quality is vital for this sector due to the connection between product quality and public health/safety. Defects in pharmaceutical drugs position a threat to human health and life.
And on a lighter note, somebody needs to police all these paperwork requirements, right?
The trouble is that internal quality can frequently slow down the overall procedure circulation, because of multiple checks and balances along the way. For instance, if mistakes are discovered in a test script throughout an SDLC testing phase, the QA department would usually get involved. They will offer oversight on how to remedy the defects and frequently require extra paperwork, such as a Test Incident Report, to document the errors and make sure compliance. While necessary, these extra steps can frequently cause delays at the same time.
Another function of the quality organization is to create requirements and processes around documents requirements. In IT, this can be found in the form of IT Controls, or a set of requirements that everyone in IT should follow around documentation governance.
Distinction # 5: Formal Document Management.
Last but not least, another major distinction is that all files need to be evaluated, approved, kept, and retired using some form of a file management system.
Technical Writing for Pharmaceuticals and BioTech (BioPhama) Technical Writing for Pharmaceuticals and BioTech (BioPhama).
For most documents, numerous approvals are required. For IT systems, reviewers and may include however are not limited to:.
· Document Coordinator or Initiator (Often a technical writer).
· The Business Process Owner (BPO).
· The IT System Owner (ITSO).
· The IT Project Owner (ITPO).
· One or more IT Project Analysts (ITPAs).
· Technical Project Lead.
· IT Quality.
· Global Quality (e.g., for GXP systems).
When everybody approves the document, it is marked with a main watermark. It then can not be changed unless a file organizer performs a brand-new workflow to alter it. The file would then go back into a draft state in the file management system.
All changes to the file need to be made in accordance with the workflow of the system, and the changes would require to be authorized by all relevant celebrations prior to it is made official. This process is called document control.
In my operate in other markets, the approval process was frequently much less formal. Typically, a document would be peer-reviewed by another technical author or by a manager. It would then be provided a spoken “looks great” or in some cases even a physical “thumbs up.”.
Conclusion.
I hope this assists paint a picture of a few of the key differences between technical writing for biopharma and other industries. I would love to find out about your experiences and whether they resemble or different than mine.
