Intro to Blog Series: GxP for Document Control in the Life Sciences
Document Control - 16 December 2013
Recently, I was asked by a client to provide guidelines on GxP for the control of electronic documents within FDA regulated environments. After talking with my team, I realized this is something we’ve been doing for years. Recognizing that end users are looking for ways to better manage and use their content, I’ve decided to propose a model on mastering the discipline of SECC (Electronic Content Control– the S is for SOLABS, so if it doesn’t work, you can blame it on us!).
In order to develop this discipline in the context of needing to manage and electronically control thousands of documents every year, we will concentrate on people and processes, as opposed to the document life cycle itself. In this case, technology plays a small part in the discussion considering that organizations using EQMS software have already mastered the discipline of Electronic Content Control (Document Life Cycle 1).
In this blog series, we will be focusing on the different “stages” that must be mastered in order to truly gain efficiency and control over compliance. This article will introduce those stages, and subsequent articles will explain each stage in more detail. Again, we will focus on people and processes since content is handled daily by a multitude of systems (ECMs, EQMS, LIMS, ERPs, etc.).
The Stages of SECC (click blue titles to navigate to blog on subject)
This stage involves deciding which document (or content) type to create and the associated attributes or tags (metadata).
2. Change Control and Periodic Reviews
Change control is without doubt a subject on its own, but here we are strictly speaking of change control for approved documents.
3. Formatting, Authoring and Reviewing
Here we refer to authors and collaborators creating and formatting documents. This stage ensures content is ready for approval.
4. Approving and Setting Effective
This is where 21CFR Part 11 has the greatest impact. The audit trail entries are created and the “regulated” history of the controlled documents begins.
5. Distribution to End-Users and Control of Copies
Distribution affects both internal and external copies. This includes printed copies, electronic copies sent internally, or copies sent to suppliers, partners, etc.
6. Retiring, Archiving and Disposal
Retiring involves the decision to retire a document or a group of documents that are no longer needed. For instance, when an instrument or equipment is no longer used, its documentation may be retired. Retired documents remain accessible. Archiving involves a set of rules to store documents or superseded document versions in a separate file system. These also remain accessible. When you are allowed to dispose of certain documents based on corporate policies or regulations, a process should be in place to ensure the ‘disposal’ process is followed.
7. Privileges and Periodic Review of Privileges
User access rights must be controlled and reviewed periodically.
8. Reporting and Analytics
Reporting is an important stage to master in order to appropriately follow-up on the flow of ‘In Process’ documents. Reporting also allows extracting information periodically on cycle times per department, who is late on reviews, etc.
In conclusion, these are the areas I will be covering in my blog series on ‘SOP for Document Control’.
Founder & CEO, SOLABS