Data integrity frowns upon time travel. Contemporaneous data collection would be hard to achieve if everyone had a time machine, but last year I had a unique opportunity to turn back the clock.
Sterling Pharma Solutions acquired a laboratory in Cary, North Carolina. The site is currently undergoing phased expansion and over the next three years, the company plans to expand the cGMP production suites, add a non-GMP scale-up production facility, expand its QC laboratory and increase the site’s R&D capacity.
One of the first investments in the QC lab was to replace their older chromatography data system with a shiny new CDS. It made perfect sense to be on the same platform as the UK site at Dudley and install Chromeleon CDS since Sterling’s UK QC and Development laboratories have over nine years of experience of using it.
Where’s My Time Machine?
I was asked the question, “We are installing Chromeleon CDS in the Cary labs, what do we need to think about?” This question prompted me to consider what I would have done differently at the start if I had a time machine to go back to our original installation.
So, what would I go back and change in my time machine? I thought about several different areas of Chromeleon CDS including:
- Folder structure and naming conventions
- Electronic signatures
- eWorkflow™ procedures, report templates, and calculations
- Control of manual integration
- Audit trail reviewing
Folder Structure and Naming Conventions
Never underestimate the value of a robust naming convention for folders and sequences. It took a bit of trial and error to get the best structure for the UK site, and with some suggestions, the Cary site opted for a slightly modified version. For me, the best practices are:
- Make sure data is stored in the correct location by minimizing the number of folders and naming them appropriately
- Eliminate ‘duplicate’ locations where analysts may become confused
- Control the use of spaces and capital letters as these can easily create replicated items
At Dudley, we are still in the process of converting to using electronic signatures for all data. I would highly advocate using electronic signatures for submission and review processes and we recommended that Cary adopt this procedure from day one with all its advantages:
- Going paperless in the lab
- Locking data in its reviewed form
- Reviewing 100% electronically (including the audit trails)
- Signing electronically proving you have accessed the electronic record
eWorkflow™ Procedures, Report Templates, and Calculations
The use of eWorkflow templates is a must for any routine analysis needing controlled sequence creation. It really does streamline and manage the sequence creation process minimizing operator errors and saving a lot of time. Also, using the Chromeleon Report Templates to their full potential allows for all results to be calculated within the CDS, eliminating errors and saving time with the additional benefit of enabling Excel to be eliminated from the lab. I previously discussed this in my blog post, ‘A Template for Efficiency, Simplicity and Consistency.’
These two items have been game-changing for me and the Dudley site. They also simplify the transferral of the methods to Cary. We can just email the eWorkflow procedure to ensure the exact methodology and reporting is replicated at the remote site.
Control of Manual Integration
You must, in a compliant environment, control manual integration. The procedures and controls we have in place now have made a seismic change in the way we perform analyses and process data. My thoughts on managing manual integration can be read in my previous blog post, ‘What’s wrong with manual integration?’ They include:
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- Have an integration SOP that documents how integration is expected to be done
- Use automatic integration first and then manual integration only if needed
- Justify any changes with clear audit trail comments
- Ensure accurate review of integration occurs and is documented
Audit Trail Reviewing
Audit trail review as part of routine data review must be implemented as soon as you start generating data. It is a requirement of both FDA and MHRA’s data integrity guidance and is always a topic that is raised during inspections. Ensuring that procedures are in place and followed is of utmost importance. My insights into audit trails can be found in my previous blog post, ‘Who Did What, When and Why?’
So, with my thoughts focused on implementing best practices the first time this time, we set out to educate the Cary team and implement Chromeleon CDS.
Two of the key members of the Cary QC laboratories visited the UK Dudley site. Neither analyst Robert Dixon nor QC Lab manager James Robb had never used Chromeleon 7 CDS previously despite being highly experienced analysts. They were taken through the Sterling CDS training plan as discussed in Walking the Training Tightrope with Chromeleon CDS by Tegan Rawlinson and, thanks to the ease-of-use of Chromeleon CDS and Tegan’s training plan, both James and Robert rapidly progressed to a good level of understanding and both eagerly awaited the installation of Chromeleon CDS at the Cary site.
Transatlantic Knowledge Transfer
The install date was set for October 2019.
With the Cary labs being a slightly smaller installation than the UK site it was decided to take a stepwise approach to the installation and expansion. With only six third-party instruments currently, we decided it would be best to set up a secure mini-network with data stored on each instrument controller which is then backed up to the main network server. As the lab expands in the future, they could then easily move to a full enterprise system or even a Cloud-based solution.
This mini-network configuration also enabled us to use global administration settings so, once the administration settings were created with roles and access groups, these were immediately active on all instrument controllers.
We were able to share our UK Chromeleon Administration Console settings with the Cary site and with slight modifications they were up and running with a compliant access-controlled set up in next to no time.
As a next step, we plan to share our administration console auditing procedures and gather evidence that the system is being controlled correctly. I previously shared my thoughts on this topic in my blog post, ‘Be Prepared to Bring Data.’
Tegan and I were asked if we would like to visit the Cary site to arrive the week after Chromeleon CDS was installed. So, one week after the installation we found ourselves beginning our journey at 3:30 am on a Sunday morning (there’s a 3:30 in the morning now?). What followed was a week of Chromeleon software knowledge and knowhow flowing from the UK to the USA. Added to the training supplied by Thermo Fisher Scientific, each lab member was taken through Tegan’s training package.
It was noticeable that the analysts in the Cary lab took to Chromeleon CDS like ducks to water. That is a testament to its ease-of-use and the analyst’s skill and hard work done before, during and after the installation.
Many thanks to Tegan and Chris (Sterling UK), and to Robert, James, Alex, Kristen and everyone at the Cary site. They all worked exceptionally hard and made us feel extremely welcome.