Cinti

Involved In Discussions
#1
Hi,

We are the manufacturer of implantable medical devices. Hence, most of the documents and records should be retained until the life time of the device. It will be around 30 years for our devices. It is not possible to transfer all documents and records as soft copy. Is there any option to minimize the paper usage? Do anyone implemented paperless office?

Cinti
 

Gert Sorensen

Forum Moderator
Moderator
#3
FDA allows you to transfer your documents to PDF as long as it is done in a controlled manner and to a controlled (validated) environment. Just have procedures in place before starting to scan them, and consider the structure of the document repository so you can easily retrieve the documents when needed. :bigwave:
 
#4
Hi,

We are the manufacturer of implantable medical devices. Hence, most of the documents and records should be retained until the life time of the device. It will be around 30 years for our devices. It is not possible to transfer all documents and records as soft copy. Is there any option to minimize the paper usage? Do anyone implemented paperless office?

Cinti
Sure! Even 40 years ago, companies faced with regulatory issues about document retention decided to save storage space by copying documents on to microfilm. The process of scanning into locked pdf files is essentially the same thing. The important factor is making the process "bulletproof" so no changes or "corruption" of documents take place other than to change the media on which data is recorded.

There are companies which specialize in efficient, secure transfer of legacy documents so you don't have to spend hours feeding documents one-by-one into a scanner.

The entire process can be covered by a revised Retention Policy which includes criteria for selecting a supplier to provide the scanning service. Most companies in the business would be pleased to provide you with templates for such a Retention Policy.
 
Last edited:

jkuil

Quite Involved in Discussions
#5
FDA allows you to transfer your documents to PDF as long as it is done in a controlled manner and to a controlled (validated) environment. Just have procedures in place before starting to scan them, and consider the structure of the document repository so you can easily retrieve the documents when needed. :bigwave:
I have heard this position of the FDA before, but do you, or anyone else know where the FDA has put it in writing?
 
#6
I have heard this position of the FDA before, but do you, or anyone else know where the FDA has put it in writing?
An excerpt from a current FDA guidance document
Under § 1271.270(c), you may maintain records electronically, as original paper records, or as true copies such as photocopies, microfiche, or microfilm. Equipment that is necessary to make the records available and legible, such as computer and reader equipment, must be readily available. You must back up records stored in electronic systems.
Example: You are a processor that receives paper records of the donor’s medical history from the recovery establishment. You review the medical history as part of the donor eligibility determination. At a later time, you scan the paper records and save them as a .pdf file on a computer that is backed up. The electronic records are “true copies” of the paper records. Therefore, you may destroy the paper records. However, if instead of scanning, you were to re-type (transfer) the information into the computer, then we cannot be certain that this is a “true copy” or if errors have been made while re-typing, either intentionally or unintentionally. So in this scenario, you would be required to keep the original paper (hardcopy) records as proof of concurrent recordkeeping.
 

Cinti

Involved In Discussions
#7
As of now we are practicing the same thing. We are scanning the documents and save it in CD. We are scanning nearly 70,000 pages per year. We are exploring the available possibilities to minimize this scanning work, saving paper cost and storage area. We deputed two full time staffs for scanning work.
 
#8
As of now we are practicing the same thing. We are scanning the documents and save it in CD. We are scanning nearly 70,000 pages per year. We are exploring the available possibilities to minimize this scanning work, saving paper cost and storage area. We deputed two full time staffs for scanning work.
By my calculation, that's about 280 pages per work day, allowing for holidays and vacations. What kind of equipment? How are they filed for retrieval? How do you distinguish when a document becomes obsolete and should no longer be relied upon? Is the backup simultaneous or performed in batches? Is the backup copy onsite or offsite?

When you say "two full time staffs" do you mean individuals or two teams?

The answers may be interesting for folks planning to convert systems.
 

Top Bottom