By Jim Newman and Ravi Kishore Kandula
Regulatory document quality is of the utmost importance in the pharmaceutical, biotechnology, and medical device industries to ensure data accuracy and provide confidence in drawing reliable conclusions. A great quality control process ensures that the writing is clear, concise, precise, consistent, and scientifically sound while maintaining the document’s structure through the use of standardized templates, style guides, and structured sources and data.
There are approaches to performing quality checking, and some may find it difficult to differentiate which approach is the best fit for a particular group.
This article provides three approaches to performing quality control, including the advantages and disadvantages of each, to help make the decision process more manageable.
Approach 1: Peer Review Process
One approach to QC is to use a peer to perform the review – this is a suitable tactic for smaller writing teams. Peer reviewing, essentially ‘phoning a friend’, utilizes colleagues of the same function for the quality control activities.
Using this informal approach means QC can be organized fluidly around other projects, but there are limitations to this method. The largest of these is that writers who are performing QC are not able to write – effectively reducing the strength of your writing team. This informal process eventually reaches a natural limit of its effectiveness when the group grows to a certain size.
Approach 2: Creating an Internal QC Group
A second solution for a growing group is creating an internal QC group, which is populated with specialists whose sole purpose is to perform QC. This is a more structured and formal method, and the processes needed for it can be rigid compared to informal approaches like peer-review.
Creating an internal QC group requires extensive recruitment, and finding candidates with the right skills can be difficult at times. Once found, these individuals will need extensive training – especially if they are new to QC as a task or new to the industry.
Additionally, a formal QC process requires a dedicated platform for QC requests to me made, details of the request shared, and the outcome of the QC disseminated. It is important to collaborate with your IT department early on to either create a bespoke platform or search for an off-the-shelf one that can adequately fit the QC group’s unique needs.
As your medical writing and QC groups grow, it can be challenging to manage peaks and troughs in your QC specialists’ workflow; there may be too many specialists during the troughs and too few specialists during the peaks. This can be mitigated by having a core team of QC specialists supplemented by a ‘response team’ of medical writers who can be brought in for peak activities.
Despite this, having an internal QC group is an excellent internal resource for medium-sized medical writing groups. This approach lends itself to very detailed QCs, as you will be able to make work allocations based on QC reviewer experience so that the most capable people are assigned to each QC.
Approach 3: Using a Third-Party QC Partner
While both previous approaches have their advantages and disadvantages, this third option is potentially a ‘Goldilocks’ option. This way of organizing QC allows organizations to use QC specialists from a third-party partner, like MMS, and it solves many of the disadvantages of the first two options, including:
- It’s suitable for any sized group
- There is no need for expensive and time-consuming recruitment or training
- No under– or over–utilization of the workforce during workflow peaks and troughs
Additionally, the third-party partner will already be working to the highest standards of quality and expectations – their business and reputation depend on it! And they will be able to adapt their approach to QC to accommodate either lean or detailed QCs as needed and as set out in the contract.
When working with a third party, it’s important to create:
- A communication plan to consistently share the QC pipeline
- Key performance indicators (KPIs) to properly measure the effectiveness
- Escalation processes in case there are times when things aren’t going as expected
In the end, determining the best quality control processes can be difficult. The decision on which route – or routes – you take to developing your quality control function ultimately depends on the size of the writing group, corporate needs, and the document’s focus. Companies may even find they prefer using various approaches at different times, depending on their workload.
Document quality is the end result of the environment of processes, personnel, and technology in which your team works. To learn more about approaches to quality control of regulatory documents, fill out the form below to register for our on-demand webinar.
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