FAQ

When we investigate for a deviation, or out of range result, we sometimes have to perform tasks that are not planned for in our procedures? How can a software system help us?

Using a solution such as SOLABS, will permit you to assign ad hoc tasks and link them electronically to a deviation/investigation process. The tasks can be assigned to any user and completed / confirmed electronically by the user. A full audit trail (part 11 compliant) is then available.

Do we have to maintain a hard copy of our procedures if we implement an electronic document management system?

At the very moment you start to use an electronic system, such as SOLABS, the only "OFFICIAL" copy is the electronic copy. Therefore only archived hard copies need to be filed.

When implementing SOLABS, what do we do with our current PDF versions of SOPS available on the network?

When implementing SOLABS, all the current PDF versions of SOPs are uploaded in the system. These are the versions available to users when the system goes live. In parallel, all editable files are uploaded as well, but available only to the document coordinator. This editable file (ie: word) will be used for the next revision/approval cycle.