Quality and manufacturing managers know that a method for documenting and reviewing accurate batch records is the single most important element in a pharmaceutical manufacturing and quality process.
That’s because, without accurate batch records, even a well-designed quality system will be vulnerable to audit findings and warning letters.
After all, nobody wants to receive a letter with a finding like this from the FDA:
Specific deviations observed during the inspection include, but are not limited to: Failure of your Quality Unit to record all quality-related activities at the time they are performed. For example, your firm failed to complete batch records at the time the API was manufactured. Specifically, the manufacturing batch record for Norepinephrine Bitartrate (lots (b)(4)) contained incomplete or missing entries regarding the manufacturing operations performed… Please note that batch records are critical records, and it is your responsibility to ensure proper, accurate, concurrent, and authentic documentation of activities associated with each lot.
This excerpt from an actual FDA warning letter makes clear how essential accurate batch records are as part of an overall quality management system. And because batch records are so vital, we can agree that investing the time and budget to implement an electronic batch records (EBR) system makes perfect sense.
So, my focus here is not on convincing you of the value of an EBR. It is to share the critical preparatory steps you should take before implementing an EBR to ensure success. I want to be sure you do not start your initiative by simply selecting an EBR but rather focus on a set of tasks that you should have on your “to-do” list further back in the process.
There are five I want to highlight.
Step 1: Spread the Word and Build a Team
Before anything else, start communicating about the batch records initiative. Select a core team of three to five leaders who will drive the initiative – that is your core team. Then, identify key stakeholders and designate them as the extended team. Identify the business sponsor (maybe it’s you!).
Hold an information meeting and tell everyone affected about the initiative so that people are supportive, excited, and not dubious and suspicious: “I hear we are all going to be replaced by an AI system – that’s why they are asking so many questions!”
Step 2: Document Your Current Process (And Be a Hard Ass)
As a first step, you need to complete a ruthlessly honest self-audit. Look at your batch records processes from an outsider’s view and interview key process participants. Ask questions an auditor would ask:
- Where is the Master Batch Record template located?
- Is it controlled effectively?
- Who can change it, and what process is used for rolling out a new version?
- Who updates batch records during the manufacturing process?
- Are they trained, and is their training documented?
- What is the review process?
- Where are completed records stored?
You get the idea. Be a hard-ass, and document the results of your assessment as the current state of the EBR process, including strengths, gaps, and weaknesses.
Step 3: Identify your “To Be” Needs
Now, working from your internal assessment, and WITHOUT thinking about any specific technology, think through a new process that addresses the issues you identified. Doing this outside of the context of a specific computer-based system is critical. We want to define a system that makes sense for your company, products, employees, and facilities.
For this step, work through a three-step process: start with a small group to identify the needs, review that work with the broader extended team, and then iterate from there.
So stay at a high level in defining your “To Be” or future-state system. Focus more on WHAT needs to be addressed than on the question of HOW it will be addressed. Ultimately, your work here will feed into a set of requirements that you can use in assessing different systems.
Step 4. Address Process Gaps. Now? Yes Now?
This may be counterintuitive, but you should take steps NOW to address significant gaps in your batch records process, even before you bring in a new system. For example, if your batch record template is missing critical information, add it now and bring it into production. If your review process needs to be improved, fix it now and start using the new process.
The natural thinking here is that “the new system” will address these gaps. And you are right, it will. But it will be easier to make some basic process modifications now, separate from the transition to an automated system. You will avoid delays and confusion, and the transition to an EBR will be smoother for the stakeholders.
I can hear you disagreeing. You may think this approach is a waste of time. Why go through the effort to change things now if they will change again?
Let’s use a practical example. When you work with an EBR vendor, you will naturally start by comparing your current batch record and the system’s default batch record to ensure the system is configured with every field you need. Well, if your current form is not complete, you will need to address that issue at the same time as the work on configuring the system. That means you will be trying to decide on details such as what the options should be for filling in that part of the form, who should have access to it, and a million other details, all at the same time you are trying to meet a schedule for getting to production.
As someone who has implemented at least hundreds of computer-based systems, I would rather separate the business decisions from the system configuration required to meet those needs so that the configuration work can move forward without doing a lot of business analysis work at the same time.
Step 5. OK, Now You Can Engage with Vendors
I will not go through the steps of identifying potential vendors, vetting them, and working through a selection process. There are about ten thousand “how to choose an EBR system” articles a Google search away, and most are written by vendors.
As a vendor, I do not want to add to that noise. Instead, I will say that services and relationships are FAR MORE predictive of success than specific functions. Whether the system will do “double secret backwards notation” – I made that up – will not make or break your EBR initiative. So prioritize relationship factors and find a vendor you feel you can trust to partner with you all the way through putting your EBR system into production.
Time to Get Started on Your EBR Initiative
Whether you complete the steps above or not, when your new EBR system comes online, it will transform your quality and manufacturing processes. You will improve quality, save time, and improve compliance with GMP standards. But if you make an effort to address the five steps above, the transition to that EBR system will be smoother, faster, and more enthusiastically supported by stakeholders and the manufacturing team.
PS. When you are ready, ask us for a demo of Scigeniq EBR.