Changing from Hard-copy / paper process to electronic process...ERP

We are changing from hard-copies of documents to electronic with a custom made ERP system.

It will be 100% electronic.

All of our current forms will be transferred into this program, but from what I see, they no longer appear to be "forms", but just tables to input information.
Therefore, I do not see any revision levels, identification numbers, etc.

Should they still be identified as such, or, because it is all electronic, it doesn't need it?

I am not familiar with going towards ERP systems, so I apologize if my questions are silly...

Thanks in Advance,
Nikki

 

"Forms" were never required in the first place...they still aren't.

Records...those are needed. But what constitutes a "Record" is by your definition....those items that you deem necessary/important.
We have shifted many of our paper records and paper recording techniques to electronic records.
At most it took the addition of a line in the governing procedure simply stating "These records may be paper or electronic or other media"

It is way more urgent to make sure that folks can/do/know how to use the new system.
That is where most of the friction comes...

FWIW, our electronic system is also custom made (by me). All procedure docs are electronic already, about 1/2 of the recording locations, and all of the compliance docs. Still working up and down the process chain...

 

Whenever you pull up the electronic form, it will always be the newest revision. Many times, the ERP is recording changes made, and thus has a revision history. It may also record who is making those changes and when. As for identification number, there has to be some unique way it is identified in the system. It is also possible that a password is required to enter the system or "sign" the report, thus making it secure.

 

As a side note, I have found the hardest part of electronic forms is having a method of direct entry. In other words, keeping people from writing all the information on a piece of paper then transfering it to the computer. Especially when it comes to acceptance testing, or PM forms.

 

A very good aspect to keep in mind...thanks...but always with the caveat that direct entry is not mandatory.
Oft times it is better, and direct entry from a gage is far less prone to errors...but I have many inputs where the cost/benefit analysis left us on a "paper carrier", or as referenced on a previous thread, the back of a latex glove.

That the right information gets to the right final place is mandatory...all the rest is cost/benefit...there is no one-size-fits-all.

 

Execpt that my Q&R would then like us to scan that latex glove into the ERP as an attachment to the form.
I'm still trying to figure out when that is "required" and when it is not. This is my first time at a medical device company. It doesn't help that my company is a little wishy washy with thier own rules.

In my past life, IQ/OQ/PQs where required to be done directly on paper then scanned, no transferring. But for PMs we could print out the list, check things off and fill out entries, then transfer the information.

I agree all that matters is that the right information gets to the right place, with as few errors as possible.

I would be interested in hearing some of the issues you encounter when transferring from all paper to all ERP, Nikki.

 

We now have a Corporate policy for Records Management. All our documents, and records we want to keep are assigned a File Name and entered in this database.

 

LOL...understood.

The point being that scan and attach vs. write & enter later vs. direct entry by typing vs. direct entry by instrument vs. ... is a choice made by the company to fit it's own way of doing things. There is freedom here for the company.
Most of the restrictions in this area are self/company imposed.

When it comes to numerical data, I wouldn't want it scanned to pdf...I want it in a form I can do statistical analysis on (XL, JMP, Minitab, database or such).

Totally good point from Roxane about power supply...thanks!

 

Yes, a natural; disaster can completely destroy electronic records, especially if they are not backed up off site. Even then, there is the possibility of loss. I always find it amusing that as technology advances it becomes less permanent and more fragile. Use the Russian way to keep your pants up, a belt, suspenders and buttons, even if it sounds a bit redundant, you will be glad you did.
Our records are backed up to the cloud and to a private server off site as well as backed up to a flashdrive periodically, still not completely safe, but best we can do other than chiseling them in some granite....

 

I have a less experienced view I wanted to share just in case the original poster is asking from a different place. When I started our QMS from the ground up a year ago we didn't have the Quality module from our ERP yet. So I made all our inspection forms from scratch. Using excel I've made templates for everything I need. Each "parent" template has a header with a revision letter that is hyperlinked to our document master list. It's just an easy way for us to control stuff and get to it quickly.

 

How are approvals to documents going to be recorded in your new system? Do you have a company policy that electronic signatures are the equivalent of physical signatures? This is the sticking point for my small company - we are paper-based, too.

 

Yeah I have no idea how we are going to record approvals once we go paperless.

That's why I am curious of this process.

We are taking the "forms" and they are becoming "fields" - not forms anymore. Because these fields are taking information and making a record out of it, do I need to control / identify / revision level these "fields"?

 

Yes, I am familiar with that kind of system - we had workflows for approvals in an electronic documentation system at my prior (much larger) employer. While I don't necessarily miss that specific program, I do miss the convenience of not being tied to paper...

It didn't sound like this system was being set up that way, given that the OP was discussing field-level approvals. I believe email approval should still be accounted for by a policy (where accepted, how stored, how matched with the thing approved). Scanned signatures would also need to be covered somehow, too (same concerns plus authenticity). Nikki, does the system you're talking about provide audit trailing for changes against which you could run a report?

 

Our header includes the Doc # and Rev letter, title, and approved by and owned by. It also hyperlinks to our master document list. If we needed to see who did what we could check timestamps and workstation logins. And every time something is printed the header has the relevant information. I'm curious if anyone feels like that is too bare bones an approach.

 

There are many benefits of digitizing documents, especially if your company relies on efficient and streamlined document storage and sharing. The benefits are data accuracy, operational efficiency, easy access, traceability, and cost-efficient. Some businesses outsource data management to data entry solutions companies to ease up the process and progress faster. When it comes to power disruptions, there are a lot of backups to be prepared, and the substitute of a physical signature is an email from the signee that can be traced.