Document Management

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.

When talking about document management we are really discussing three major types or functions:

  • 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.

document 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.

ALCOA or ALCOA+

My colleague Michelle Eldridge recently shared this video for the differences between ALCOA and ALCOA+ from learnaboutgmp. It’s cute, it’s to the point, it makes a nice primer.

As I’ve mentioned before, the MHRA in it’s data integrity guidance did take a dig at ALCOA+:

The guidance refers to the acronym ALCOA rather than ‘ALCOA +’. ALCOA being Attributable, Legible, Contemporaneous, Original, and Accurate and the ‘+’ referring to Complete, Consistent, Enduring, and Available. ALCOA was historically regarded as defining the attributes of data quality that are suitable for regulatory purposes. The ‘+’has been subsequently added to emphasise the requirements. There is no difference in expectations regardless of which acronym is used since data governance measures should ensure that data is complete, consistent, enduring and available throughout the data lifecycle.

Two things should be drawn from this:

  1. Data Integrity is a set of best practices that are still developing, so make sure you are pushing that development and not ignoring it. Much better to be pushing the boundaries of the “c” then end up being surprised.
  2. I actually agree with the MHRA. Complete, consistent, enduring and available are really just subsets of the others. But, like they also say the acronym means little, just make sure you are doing it.

Data Integrity, it’s the new quality culture.