Quality System Documentation...

In a digital era. The challenges for an organization.

The following is an excerpt from a US FDA warning letter to a manufacturer regarding the need for good documentation:

“Complete, true and accurate records are the foundation for good GMPs (Good Manufacturing Practices). Reliable documentation is a control, which raises assurance of the quality of the product manufactured. Violations concerning inadequate documentation are serious and should be handled as such.

Clearly the regulatory authorities expect adherence to and implementation of good documentation practices. In addition, to being forced by the regulatory bodies to implement a quality system documentation process, there are more fundamental reasons for implementing such as:

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i) Good documentation practices reduce the risk of errors versus reliance on oral communication.
ii) Written communication stays constant.
iii) Documents can be easily rechecked.
iv) There tend to be fewer misunderstandings with written communication.
v) Documentation provides direct back-up evidence of a communication.
vi) Documentation clearly defines the system of control.
vii) Ensures consistency between users and over time.
viii) Documentation allows for clear traceability.
ix) Clear documentation helps understanding and ensures that tasks are consistently and safety applied.
x) Provides clear records.


The above is not an exhaustive list. but does give an indication of the reasons for implementing good quality system documentation. These positives tend to be well understood and accepted, even if the application of good practices in terms of a quality system documentation process can be somewhat lacking in some organizations.

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The question for organizations in the digital era, is how to optimize the benefits technology brings, in terms of say having soft copy documentation available at work stations, which allows for easy revision, easy sorting, etc., versus paper copy documents, which can get lost, or allow for (as we’ve all come across) the old out of date document to remain around sitting in a drawer somewhere.

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While digital versions of documentation provide many advantages, there can be challenges.

i) The awareness of the paper copy of a procedure sitting at a work station, can be superior to a soft copy file within a desktop or laptop.

ii) Operators can sometimes feel removed from soft copies, versus paper copies, i.e. the digital version of a procedure can be seen as “belonging” to the Quality or Engineering staff, versus the physical paper copy.
iii) Process operators who do not feel fully competent or comfortable with submitting change requests via an organization’s intranet, may decide to avoid raising documentation updates. The paper copy document, allows hand mark-up, which may sit more comfortably with some process operators.

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iv) If an organization does not have software in place that provides clear record change trails, then the integrity of soft copy records can be compromised.

The above are a sample of potential drawbacks associated with digital documentation versus paper documentation. None of the challenges are insurmountable, however, organizations must be aware of the advantages and disadvantages of having a 100% digital documentation system in place, and need to implement controls, training, audits, etc., to ensure the benefits of good digital Quality System Documentation to the organization.

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