How SOPs, Policies, Work Instructions, and Job Aids Keep Biotech Companies Running Smoothly
- Sarah Dittmann
- Mar 11
- 3 min read
When it comes to maintaining compliance, efficiency, and consistency in a small pharma or biotech company, having the right documentation in place is crucial. However, the variety of documents—Standard Operating Procedures (SOPs), policies, work instructions, and job aids—can sometimes cause confusion. Understanding the role of each document type and how they work together ensures smooth operations, regulatory compliance, and effective training.
1. Policies: The High-Level Framework
Definition: Policies are overarching guidelines that set the expectations, principles, and general rules for an organization. They establish the “what” and “why” of an operational area without detailing the “how.”
Example: A company might have a Data Integrity Policy stating that all electronic records must comply with FDA 21 CFR Part 11 requirements. However, the policy will not specify the step-by-step process for ensuring compliance.
2. Standard Operating Procedures (SOPs): The Roadmap
Definition: SOPs provide detailed instructions on how to execute specific processes in a consistent, compliant, and efficient manner. They answer the “who,” “what,” “when,” and “where” while setting the stage for more granular instructions.
Example: A Clinical Data Management SOP might outline the responsibilities of various team members, the required documentation, and the overall workflow for handling clinical trial data.
3. Work Instructions: The Step-by-Step Guide
Definition: Work instructions are more detailed than SOPs and describe specific tasks within a process. They typically break down an SOP into clear, step-by-step actions that an employee needs to follow.
Example: A work instruction might detail how to enter clinical trial data into an electronic data capture (EDC) system, specifying which fields to complete and how to validate entries.
4. Job Aids: The Quick Reference Tool
Definition: Job aids are simplified tools designed to help employees quickly reference key information while performing a task. They are not meant to replace training but to support workers in real time.
Example: A data entry checklist for the EDC system can serve as a job aid, reminding employees of critical validation checks before finalizing their entries.
How These Documents Work Together
To illustrate the relationship between these documents, let’s look at a real-world example in a small biotech company preparing for an FDA submission:
Policy – The company has a Regulatory Submission Policy stating that all FDA submissions must adhere to eCTD requirements.
SOP – An eCTD Submission SOP details the roles, timelines, and documentation requirements for preparing and submitting regulatory applications.
Work Instruction – A submission formatting work instruction outlines the specific steps for compiling documents, hyperlinking sections, and validating the submission.
Job Aid – A quick reference guide lists common validation errors and how to fix them before submitting the eCTD package.
Why This Matters for Small Pharma and Biotech Companies
For small companies with limited resources, well-structured documentation helps streamline operations, improve training efficiency, and ensure compliance with regulatory bodies like the FDA. A clear distinction between policies, SOPs, work instructions, and job aids reduces confusion and enhances operational effectiveness.
By understanding and implementing these document types appropriately, small pharma and biotech companies can enhance compliance, minimize errors, and improve overall efficiency in their critical processes.
If you need help figuring out which compliance documents you need and authoring them, The Sugar Water Operations Team is here to help. We specialize in helping create real-world processes designed specifically for your company’s capabilities and goals. Contact us to learn more about what we can do for you!
