Sometimes also referred to as Quality System Documents (QSDs), especially in software, SDLC, and product development, these documents are established as references for use in audits by agencies, clients, or internal functions.
In Pharmacy practices and Pharma in general, Policies govern all processes. A policy document dictates the order in which procedures are followed for that given policy.
Under Policies lie the Standard Operating Procedures (SOPs). Collectively, the SOPs combine to form the basis of a policy and the root structure of the work instructions.
Within each SOP is one or more Work Instructions that dictate the processes followed to complete the SOP.
Parallel to Work Instructions as well as SOPs may be one or more Guidelines and Technical Notes that provide clarity on ambiguous scenarios or technical details not covered in the other documents.
In place of Work Instructions, sometimes Deviations or Exceptions are written to account for a break away from the standard workflow of the Policy’s lifecycle.
Overarching Manuals may be provided as optional references of a high-level synopsis that explain under what circumstances which policies are instituted for a given project or feature.
Beneath Work Instructions at the most basic fundamental level are Runbooks, typically reserved for information technology-specific instructions of a certain piece of equipment or hardware that would be a segue from a section of a Work Instruction or too overly detailed to include in a formal Work Instruction and extracted so as to keep proprietary information separated from reviews performed during an audit. Such examples include the steps for resetting the Admin password on a server that controls publicly available webpages.
With over a decade experience in writing user manuals, help guides, how-to articles, and technical notes, PharmHandz Associates has cornered the market and set the bar on the standards and quality expected of documentation providing instruction and guidance on processes or product features.
Samples and examples are available upon request. Contact us anytime to request a consultation on how we can best accommodate your requirements for the budget and timelines approved for your project. Our past and current clientele unanimously agree that the products published by our team is unmatched in quality and professionalism across the industry and demand our services for other projects as they become available.
We work with all budgets, all industries, all levels of an organization’s workforce, and all software applications. With no document or project too big or too small, we specialize in making sure you remain well informed throughout the process, have all the information necessary to make informed decisions, and can access all the tools and resources necessary to remain an integral part of the project lifecycle as your documents are developed. Contact us for more information.
Knowing the product is an important aspect to creating a document about it, but just as important is understanding the audience, being familiar with current industry best practices, and having expert-level experience in minimalist design to ensure simplicity meets perfection in an ideal platform of information exchange the audience can easily understand and identify with. PharmHandz produces documentation under its parent organization Papoose Doorbelle Publishing, which handles every aspect of the documentation lifecycle from researching and preparing the materials to add to document, to preparing templates custom tailored to your organization’s brand standards and expectations, to managing the draft and review cycles between copyeditor, author, and researchers, to final publication and acquiring an ISBN number as appropriate.
Documents vary in costs based on budget, time constraints, size of final product, type of document, number of deliverables required, amount of research involved, and a few other factors that all combine to total an affordable rate for the project, whether by hourly rates, project basis, per page, or other variations all dependent on how we can best accommodate our clients and their expectations.
Contact us when you are available to discuss your next project, and we’ll provide valuable insight into the scope and effort involved in meeting your requirements in realistic, down-to-earth terms that will exemplify our commitment to our customer’s satisfaction and high quality output.