- 1 RA/QA Specialist
- 1 SOP writer
- 1 Project manager
Project Planning (including project scope and SOP gap analysis)
Designing and compiling new SOPs and templates.
Managing reviews of new SOPs and templates with client stakeholders.
Designing and compiling training materials and conducting trainings for new SOPs.
Piloting new SOPs and templates.
Fine-tuning new SOPs and templates based on the results of piloting.
Designing and compiling rollout plan for new SOPs.
Standard operating procedures (SOPs) provide a foundation for building software by:
- Identifying precedence
- Laying ground rules
- Streamlining processes
- And offering the transparency necessary for future optimization.
In clinical research, the International Council for Harmonisation (ICH) defines SOPs as “detailed, written instructions to achieve uniformity of the performance of a specific function”. SOPs usually get applied in pharmaceutical processing and for related clinical studies.
How to write SOPs?
You may be wondering how you can actually go about creating your own, which is a natural way of thinking. Standard operating procedures require a lot of planning and preparation before you can even begin writing the document. Our experts rely on years of experience developing medical software to ensure our clients’ operating procedures reflect their needs while meeting the challenges of changing industrial trends. We can help improve existing SOPs as well as guide firms in building their own from the ground up. The process is the following:
- Develop a list of your business processes
- Plan the process
- Talk with employees
- Write and review the process
- Maintain the process
Having standard operating procedures in place will also give you the option to scale your business more quickly. This is because standard operating procedures make it easier to replicate these processes across your organization. Click here and LET’S TALK, because we are experts in this field, so we can help to scale your business more quickly.