How to Store an Electronic Signature

Electronic Signature

Hello good people of the world! Today’s post is a short one on the topic of electronic signatures. 21CFR11 includes requirements around the use of electronic signatures in place of traditional handwritten signatures and these requirements are fairly well understood at this point. The question of this post is, how should your electronic system store the electronic signature?

It is important to understand that electronic signatures are meta-data. That is, they are data about data. So if you have an electronic batch record, for example, the electronic signature recorded during approval is not part of the batch record data, but meta-data of the batch record data. In this example, it is specifically the who, what, and when of the batch record approval.

Given that, electronic signature data should not be included in the same record (table row, document, etc.) in the electronic system. It is meta-data and should be handled as such, an important consideration in electronic system design. This will ensure electronic signature data is robust, auditable, and readily available.

How do you store electronic signatures? Any lessons learned? Comment below.

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Validation of Legacy Processes and Equipment

abandoned factory
Hello good people of the world! Today’s post is about dealing with legacy processes and equipment from a validation perspective.

I’ve worked in two plants that have legacy processes/equipment. By legacy, I mean processes/equipment that can be decades old. These processes have been producing products for the market for a long time. Initial validations will not meet the standards of today, if they exist at all. It is typical that documentation for legacy processes/equipment will not meet the today’s standards as well, and may also be nonexistent.

So how do you handle legacy processes/equipment from a validation point-of-view? First it is important to consider that because the product has been on the market for some time, there is a proven track-record. This must be leveraged. Also, legacy processes have been audited internally and externally many times. It is important to look at those audits to see what gaps and/or risks have been identified.

The next challenge is how to document changes to legacy processes/equipment. It can be difficult to track changes to equipment that, for example, does not have up-to-date P&IDs (Piping and Instrumentation Diagrams). Because creating missing documentation after installation can have a large resource cost, it will be up to the organization to determine their documentation needs and what risks they are willing to assume. This can lead to challenging conversations within the organization and unique validation programs.

What have you learned working with legacy processes/equipment? Comment below.

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Corrective Action / Preventive Action (CAPA)

CAPA Process
Hello good people of the world! Today’s post is about Corrective Action / Preventive Action, typically referred to as CAPA. CAPA is an integral part of any Quality System, and certainly one of the first things an agency will look at in any audit.

There is a ton of good information out there already on CAPA, including FDA’s own guidance from 2014.

I’ve personally used a few software packages for CAPA management, including MasterControl and Oracle’s Agile, among others, but have not seen any standouts.

The key points of the CAPA program are:

  1. Issue identification, i.e. ensuring the issue is truly understood and well documented
  2. Root cause analysis, i.e. identifying the root cause of the issue
  3. effectiveness check, i.e. verifying actions have actually resolved the issue

What tips have you learned from your CAPA program? Comment below.

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Free Offer! Get Your Org Chart Online and Organized

Portfolio10Hello good people of the world! As you probably know, one of the first things an agency is likely to ask for in an audit is your company’s organization chart. They want to know how the organization is structured, and particularly where the quality unit fits in.

If you have a SharePoint tenant, I have an offer for you. For a limited time, MWV, in conjunction with dikuw.com, is offering a free SharePoint Add-in for generating organization charts. This add-in integrates with your existing SharePoint On-Premise or Online service, and gives a secure, centralized location for your org chart. The custom interface makes it easy to navigate and update the chart in real-time.

Get all the details and download the add-in here: http://www.dikuw.com/OrgChart.html

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Warning Letter: Daito Kasei (Japan)

WarningLetterFDA

Hello good people of the world! Today’s post is about a recent (January 2018) warning letter issued by the FDA to a Japanese cosmetics and drug manufacturing company called Daito Kasei. The warning letter, which can be found here, underscores the need maintain focus on data integrity requirements in our modern age. This warning letter includes explicitly the following data integrity remediation steps: Continue reading Warning Letter: Daito Kasei (Japan)

Start-Up Tip: Task Duration Buy-In

Buy In.jpg

Hello good people of the world! Today’s post might be a bit of a rant, but this is something I’m seeing lately and is a good way to kill your project schedule. What I’m talking about is task duration buy-in. It is critical in a start-up project to get all stakeholders and especially responsible parties to buy in to the amount of time they are allotted for each task in the schedule.

And I mean formal buy in. Get it in writing. Have them sign their name to it.

Too often I have seen a schedule suffer due to this gross oversight. Yes, a schedule may say you have three days to complete a task, but if that duration feels arbitrary or not “owned”, it is not going to be met when other priorities come in to play. This is especially true with resources that are not used to working in start-up environments/come from steady-state situations.

Get buy in, have consequences for failing to meet dates, force resources to delegate when they are overwhelmed.

What’s your go-to method for getting buy-in on task durations and keeping that schedule moving along?

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