Keeping and managing current and historic versions of standard operating procedures (SOPs) has become a monumental task within the industry for almost all players. From Sponsors and CROs to Labs and EDC vendors, we all have the same problem: how do we maintain ever-changing SOP versions with management signoff and records of who was trained, when, and were compliance signatures logged?
Look no further, VISION Pre-Built has a template for that and we can customize it to your needs!
With our SOP Tracking system you are able to categorize your current SOPs and organize them in a way that makes sense to your team. Within each category you are able to migrate your existing SOPs directly into the system and from there you’re free to make edits knowing each edit is being tracked much like an audit trail within a study. A revision history is kept for each SOP showing who made the edit, the date the edit was made and a revision description noting the reason for update. Add new SOPs as they are needed or remove SOPs that are no longer necessary. Each SOP is assigned a unique ID for easy reference and organization. Do you have supporting documents for your SOPs? Those can be uploaded into the system and logged along with the relevant SOP. Finding and accessing supporting docs no longer requires digging through folders and files, they’re now just a click away.
The personnel on your team are assigned user accounts with training logs that can be added as needed. Each log contains an exhaustive list of all your active SOPs. When SOP training occurs, each participating team member is able to log their training (which SOPs, date of training, name of trainer and training type) as well as electronically signoff on the training. QA can then logon and review any and all training logs both current and historic.
The benefits are not only internal management but also apply for external audits. It becomes quick and easy to give a visiting auditor read-only access to the SOP tracking system so they can review both the SOPs themselves as well as the training logs.