Today many companies are going digital, striving for paperless, reinventing how individuals find information, record data and make decisions. It is often good when undergoing these decisions to go back to basics and make sure we are all on the same page before we proceed.
There are three major types/functions of documents:
- Functional Documents provide instructions so people can perform tasks and make decisions safely effectively, compliantly and consistently. This usually includes things like procedures, process instructions, protocols, methods and specifications. Many of these need some sort of training decision. Functional documents should involve a process to ensure they are up-to-date, especially in relation to current practices and relevant standards (periodic review)
- Records provide evidence that actions were taken and decisions were made in keeping with procedures. This includes batch manufacturing records, logbooks and laboratory data sheets and notebooks. Records are a popular target for electronic alternatives.
- Reports provide specific information on a particular topic on a formal, standardized way. Reports may include data summaries, findings and actions to be taken.
Often times these types are all engaged in a lifecycle. An SOP directs us to write a protocol (two documents), we execute the protocol (a record) and then write a report. This fluidity allows us to combine the types.
Throughout these types we need to apply good change management and data integrity practices (ALCOA).
All of these types follow a very similar path for their lifecycle.
Everything we do is risk based. Some questions to ask when developing and improving this system include:
- What are the risks of writing procedures at a “low level of detail versus a high level of detail) how much variability do we allow individuals performing a task?) – Both have advantages, both have disadvantages and it is not a one-sized fits all approach.
- What are the risks in verifying (witnessing) non-critical tasks? How do we identify critical tasks?
- What are the risks in not having evidence that a procedure-defined task was completed?
- What are the risks in relation to archiving and documentation retrieval?
There is very little difference between paper records and documents and electronic records and documents as far as what is given above. Electronic records require the same concerns around generation, distribution and maintenance. Just now you are looking at a different set of safeguards and activities to make it happen.
25 thoughts on “Document Management”
A few questions on the life cycle drawing: Documents are issued for use, are these “stepping out” of the life cycle? And what are executed records and why are these being assigned for archival?
The intent of the drawing is not to show a step out, but instead to show how the transformation of the document into a record ready for archiving, its execution as a input/output in another set of processes, is still under the document management cycle.
The document is prepared for executed (transformed into record)->executed->archived. The transformation into record is a key step, and all records are stored (archived) appropriately.
Hello Genest sir,
I need some articles relating to the life cycle management of quality documents. I couldnt find.
Can you please help me sir?
I am doing a review on the same.
Sorry I missed this. Are you looking for just a citation search or some of my favorites?