Validation Protocol for a paperless system?

Hello, I am trying to institute a policy here at our medical device company that will allow us to scan our quality records and destroy (shred) the paper.

I know that the standards are that the documents have to be legible and easy to access, but I can't find a sample protocol that will allow me to validate that the system we are using will work with the FDA.

I know there has to be one as I have been working in medical devices for years and other companies do this sort of thing. Can anyone help?

steend said:

Hello, I am trying to institute a policy here at our medical device company that will allow us to scan our quality records and destroy (shred) the paper.

I know that the standards are that the documents have to be legible and easy to access, but I can't find a sample protocol that will allow me to validate that the system we are using will work with the FDA.

I know there has to be one as I have been working in medical devices for years and other companies do this sort of thing. Can anyone help?

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Hi and welcome to the Cove, steend! I do apologize for the lack of a response on your question...that seldom happens here.

I am no expert in the medical field, but I do like your idea to scan in documents to help reduce paper storage. Keep in mind, that in order to have such a system, you will most likely require a really good back-up process to ensure that your records are protected and can easily be recalled in case of a disaster (e.g., fire, water damage) at the main office.

Perhaps you could contact the FDA and get their opinion on this issue? And it would be great if you could post their response here, too, for the rest of us.

Hello steend. Unfortunately, I'm quite unable to answer your question, but I can wish you welcome to the Cove

/Claes

steend said:

Hello, I am trying to institute a policy here at our medical device company that will allow us to scan our quality records and destroy (shred) the paper.

I know that the standards are that the documents have to be legible and easy to access, but I can't find a sample protocol that will allow me to validate that the system we are using will work with the FDA.

I know there has to be one as I have been working in medical devices for years and other companies do this sort of thing. Can anyone help?

Click to expand...

Steend, Welcome.
Give me a bigger picture (The Girraffe view as Claes says)
How large is your organization?
How many departments?
What system of document control are you currently using?
Do you use PC or MAC throughout your departments and, is it a networked system?
Wallace.

Sap library - Electronic Records

Have a look here may be useful for you

1. http://help.sap.com/saphelp_erp2004/helpdata/en/88/b94d3c6b6f3745e10000000a11402f/frameset.htm
2. http://help.sap.com/saphelp_erp2004/helpdata/en/9d/e00c3c3fd5af47e10000000a114084/frameset.htm

ps. I'm not Sap Consultant but I hope that somebody of them give me Karma points)

Cavanna said:

Have a look here may be useful for you

1. http://help.sap.com/saphelp_erp2004/helpdata/en/88/b94d3c6b6f3745e10000000a11402f/frameset.htm
2. http://help.sap.com/saphelp_erp2004/helpdata/en/9d/e00c3c3fd5af47e10000000a114084/frameset.htm

ps. I'm not Sap Consultant but I hope that somebody of them give me Karma points)

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Most of the big outfits, SAP, Documentum, etc. which supply electronic document management programs have specific modules for specialized industries like pharmaceuticals. These modules take into account the government regulations and special process circumstances of the industry in adding features.

ALL of the worthwhile electronic document management programs (edm) have some sort of security feature which allows the person creating or adding a document into the system (hard typing or scanning) to verify its authenticity by a password-protected signature. Similarly, most edm have security levels (up to thirty or more) which give permission to view, print, modify, add new, delete, notate, etc. The security level is controlled by permissions given each user by the system administrator.

KARMA:
Cavanna is to be commended for citing the SAP sales material which directly addresses the requirements of FDA and its cGMP. Perhaps a COVE member who is an SAP employee will give him Karma for that. I'll give him karma for helping point out that others have encountered the situations many of us face. Those same "others" have probably found solutions. It is up to us to try to avoid re-inventing the wheel by finding and using those solutions. The beauty of the Cove is that we have "friends" who help us find those solutions. Cavanna is one of those friends.

Wes Bucey said:

KARMA:
Cavanna is to be commended for citing the SAP sales material which directly addresses the requirements of FDA and its cGMP. Perhaps a COVE member who is an SAP employee will give him Karma for that. I'll give him karma for helping point out that others have encountered the situations many of us face. Those same "others" have probably found solutions. It is up to us to try to avoid re-inventing the wheel by finding and using those solutions. The beauty of the Cove is that we have "friends" who help us find those solutions. Cavanna is one of those friends.

Click to expand...

Sometime i think to leave quality assurance departements, also in the past i was very found in quality assurance so that i went to buy a lot of quality managemnts books and I began to attend many course on the management of the quality. unfortunately, from approximately 15 years, the position that I have in the company in which I carry out my profession does not allow me to have the satisfactions that previously carried to me to cultivate this passion. Many thanks, to be commended from you, is a suggestion for going again straight in this street.