This is an MS Word template to be used as a starting point for preparing a standard SOP. Regulatory bodies and electronic records compliance guidelines require that organizations have formal documentation describing their business, quality assurance, and compliance. Along with policies and work instructions, procedures or standard operating procedures (SOPs) are the tools that make this task possible. We have included a proposed structure for an SOP as well as draft language and other guidance to assist you in creating a good SOP.
We have saved this template in different formats (.docx, .dotm, .dotx, .docm, .doc, and .dot) to make sure it is compatible with all systems.
Please note that in this Standard Operating Procedure Template:
- The yellow-highlighted text enclosed with [ ] indicates a placeholder where a specific detail is to be inserted (replace as appropriate).
- Ensure that all placeholders and example text is replaced with the function-specific information.
- In the template, the instructions and explanatory text are indicated by <blue italics>, which is used for explanations only and must not be included in the final document.
- Please review this template and feel free to adapt it to the specific needs and requirements of the monitoring group and study.
- The logo of the Institution must be used on this form.
- Leave the template version information in the document.
Using this Standard Operating Procedure Template and the instructions provided in it:
- Helps you to follow the guidelines for preparation of a compliant SOP that addresses your requirements.
- Assists the SOP developers to include the required items / sections in this document.
Who Can Benefit From This Standard Operating Procedure Template
This Standard Operating Procedure Template is intended to assist the following in the process of creating an SOP for any organization / activity:
- Anybody who is interested in standardizing practice and improving productivity / quality
- Manufacturing & Production Personnel / Managers
- Research and Development Personnel (R&D) / Managers
- Quality Assurance & Quality Control Personnel / Managers
- Regulatory affairs personnel / managers
- Laboratory Personnel / Managers
- Validation Specialists
- Clinical trial personnel
- Project Managers
- Technical / medical writers
- SOP users
- ID: 1350
- SKU: TE-0002-RC
- Type: Template
- Format: Template File (.docx, .dotm, .dotx, .docm, .doc, and .dot)
- Date of Last Update: Jan 10, 2017
- Price: $20.00
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