Facilities management provider Sodexo works with a string of the biggest blue-chip household names in the pharmaceutical industry.
'Hard' and 'soft' facility management for the tightly regulated pharmaceutical world requires airtight quality control.
Sodexo's EQMS Manager Rob Gibson discusses how he uses Qualsys's software solution to help Sodexo's pharmaceutical clients save time and prepare for audits, and why the Sodexo teams using EQMS are 'raving about it'.
Read the interview below.
Qualsys: Sodexo manages sites for some of the biggest pharmaceutical companies in the world. What regulations and standards are you required to stick to to provide services like that?
Rob: Some of those depend on different markets, but our main one is GxP. Good general manufacturing processes, documentation practices, laboratory practices and so on, guided by best practice in the community.
Then there are external regulators. Each country has its own auditing body who will make sure the medicines are safe and you can prove that they are, and that there are records to show that the staff involved in the manufacture were trained in the right procedures, and that there are procedures.
There's the American Code of Federal Regulations enforced by the FDA, the European body which is very similar but slightly different, the MHRA in the UK.
Any one of those bodies can come in for an inspection so we have to meet their standards. Those standards are always evolving and improving through lessons learnt, and through the continuous improvement of quality mindsets we can make things better, safer, faster, more efficient, more lean.
AstraZeneca's Macclesfield site, where IFM services are provided by Sodexo
Qualsys: What would you say are the biggest challenges and mistakes to avoid in the pharmaceutical world?
Rob: One of the big gaps is if something happens, not having the right documentation and information about the people, the process, the plant, the product. If there's a gap there you have to assume the worst.
There's a saying: "if it's not written down, it's a rumour". Having EQMS, having a library to make that easy, to be able to search records by date, by time, by person, by area, by geography, by service makes it easy to find things and answer questions really quickly.
With EQMS being web-based, you can do that from anywhere. It's not rocket science, but it's really, really powerful in this context.
Sodexo's documentation is stored in Qualsys's document management module to demonstrate compliance and guarantee security
Qualsys: What advice and tips could you share with other pharmaceutical quality professionals implementing Qualsys's solution?
Rob: It's important to make sure everyone in the team knows what the goals are and keeps focused on those.
These are big projects and it's very easy to start expanding, and queries and questions start coming in, and grow very rapidly.
A bit of focus on the key milestones and key deliverables helps. Perhaps you're trying to solve a problem with training records. Perhaps it's about documentation. Perhaps you need a tool to help you with internal inspections and audits.
So focus on the goals, understand what your operations and clients need to do.
There's a saying: "if it's not written down, it's a rumour". Having EQMS, to be able to search records by date, by time, by person, by area, by geography, by service makes it easy to find things and answer questions really quickly.
With EQMS being web-based, you can do that from anywhere. It's not rocket science, but it's really, really powerful in this context.
Make sure you've got the buy-in and the right people for the job. Make sure people are trained and they are culturally using it, and sell it to them.
Tell them, "this will help you do your job smarter, it'll reduce the hassle and time spent, you don't have to do that report anymore because the system will do it for you".
Make sure people understand what's in it for them. You're on the road to success then. Let people know when things are up and running - there's some real good news to come out of a project like this.
Adhering to good laboratory practice standards is crucial for Sodexo and their pharmaceutical customers
Qualsys: How does Qualsys's solution help you in your day-to-day role as EQMS Manager?
Rob: There are a few dimensions to that. The first is knowing that the system is validated and fit for purpose in the pharma market.
It's really useful to use some of our existing EQMS-implemented sites as references for other customers. Stakeholders are naturally worried and apprehensive about letting someone else do their job for them; it's like choosing a cleaner for your house or a babysitter for your children.
Being able to show them something tangible and real is better than a brochure; people can see it and touch it and see that it works. That's really helped us.
Sell your EQMS system to them. Tell them, "this will help you do your job smarter, it'll reduce the hassle and time spent, you don't have to do that report anymore because the system will do it for you". Make sure people understand what's in it for them. You're on the road to success then.
The second is knowing that the software has some very real solutions about document management, audits and inspections, training records, CAPA process flows, being able to record actions and findings to be worked on and corrected and logged, and seeing how long it took and who they were assigned to.
Knowing that we have all those tools in the toolkit really helps solve the problems that the pharma world faces.
It really is a fully-fledged suite of tools that we can use to solve problems, configured to local needs of clients and keeping ourselves operational and supporting the needs of the regulations that we work to.
Stakeholders are naturally worried and apprehensive about letting someone else do their job for them; it's like choosing a cleaner for your house or a babysitter for your children.
Being able to show them something tangible and real is better than a brochure; people can see it and touch it and see that it works. That's really helped us.
Sodexo and Qualsys teams in ISPE GAMP training
Qualsys: Has becoming a Qualsys customer helped Sodexo save time?
Rob: Absolutely. EQMS definitely saves time in a number of ways. We had a really brilliant example from Audit Manager, where we had somebody performing a fairly detailed inspection that took the best part of a day.
By capturing findings in iEQMS as they were recorded and supporting with photo evidence, we could then generate a report instantly. That would usually take a full man-day of typing and editing, lots of Microsoft Word work. By just clicking a button, all the actions, findings, scores, compliance figures, photographic evidence is generated in a few seconds. That can save a day per audit, which gives the auditor more time to think or to go elsewhere.
The software has some very real solutions about document management, audits and inspections, training records, CAPA process flows, being able to record actions and findings to be worked on and corrected and logged, and seeing how long it took and who they were assigned to.
Knowing that we have all those tools in the toolkit really helps solve the problems that the pharma world faces.
We've also got our training records stored in EQMS. That's killed off quite a few Excel spreadsheets, which can be difficult to run reports against. That's helped our teams make the best use of their time.
And another thing that it does: it's stopped things going wrong. Operationally you do spend a lot of time fixing things when they don't go right. By using the good practices in EQMS and stopping things going wrong, there's a whole lot of time and money saved.
Sodexo's Global VP of Quality & Compliance Carl Stanbridge estimated a 60% reduction in auditing time with Qualsys's mobile auditing application
Qualsys: What’s your personal approach to preparing for audits? How does Qualsys’s solution help?
Rob: I guess we know the kind of things we have to comply with and the kind of things an auditor will ask. "Can you show me how your staff are trained?" We can anticipate that question and have some training records ready to show. There are some common questions and common themes that arise every time.
There'll always be some left-field questions that an auditor will come up with - we answer those as best we can and learn from them for next time.
Regarding our operational sites, the auditors are coming from the same direction - they're trying to demonstrate that we're operating in a compliant manner. It's quite easy to run a report in EQMS if an auditor says, "show me these documents. Have any of these gone out-of-date? Do they need reviewing?"
We know if we do have a document published five years ago that hasn't been updated then an auditor's going to find it, and we can make sure it's been checked and reviewed beforehand.
Same with training records. If we anticipate someone saying, "show me that your staff have read that procedure and they understand it", we can organise a training course and record it in EQMS to demonstrate that that team were trained on that day according to this standard, and here's the proof that they've understood it.
That's really helped speed things up. Some of the feedback we've had from our external auditors is that they've been impressed by the speed and efficiency of EQMS compared to paper records. The accuracy, the audit trail, the data integrity means information can be retrieved so much faster than having to run off to the filing cabinet.
Rob recommends anticipating typical auditor questions, getting the evidence prepared beforehand, and taking unanticipated questions as lessons for next time
Qualsys: How has EQMS impacted the culture of Sodexo's pharmaceutical operations?
Rob: Within our pharma arena, EQMS is getting a name within our teams: if you're operating in this marketplace, EQMS is the tool. It's it. It's the best tool that we have and it fits the bill very, very nicely indeed. We're using many of the features and there's a few more that we're yet to touch because we're still expanding.
The pharma teams do share hints and tips and findings and incidents with each other to improve their best practice, and the ones who are using EQMS are raving about it. That creates a pull for the few pharma clients we have that aren't using it, who say, "we want this tool, how do we get hold of it?"
So good news spreads. It's a fact that good news spreads, and it is spreading through the Sodexo network.
We are growing, the EQMS team is growing, the number of sites using EQMS is growing, and we can see it growing quite a lot over the next few years. So some more good news that will cascade and cascade as we grow.
If you're operating in the pharmaceutical marketplace, EQMS is the tool. It's it. It's the best tool that we have and it fits the bill very, very nicely indeed. The pharma teams who are using EQMS are raving about it.
What to do next
Rob gave a presentation on Sodexo's quality management software strategy at the AIIM 2017 forum. Watch the presentation here.
Sodexo's Global VP of Quality & Compliance Carl Stanbridge reported a dramatic reduction in auditing time after implementing Qualsys's solution. Download the case study here.
Or see how we helped our other life science customers build robust, integrated quality into their operations with our case study booklet here.
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