Managing and controlling Standard Operating Procedures (SOPs) and Training Records play a central role in every regulated life sciences company. Moving the creation, review and approval of SOPs from a paper-based process is a first step for many organizations moving to an automated document management solution such as SharePoint. Full compliance with 21 CFR Part 11 requirements requires more than just control of SOP documents, however. Affected staff members need to be trained on approved SOPs and records of that training need to be maintained.
During this session, you will learn from our experience deploying more than fifty SOP management systems based on SharePoint. You will learn how SharePoint and NextDocs combine to address all requirements of 21 CFR Part 11, and you will see an end-to-end demonstration of an SOP and training records solution built on SharePoint 2010.
Here is what we will cover during this session:- Regulatory requirements for SOP management and maintenance of training records.
- Alternative approaches to connecting SOPs and Training records.
- How training requirements and activities interact with SOPs to create complete training records
- Demonstration of a completely integrated SOP and Employee Records solution based on SharePoint and NextDocs