Thanks for all the great responses. I send really long emails anyway so I didn't include some of the background information. The question about shrink wrapping came from our internal auditor who saw some boxes of other clients had been shrink wrapped. It gets really interesting when you discuss FDA requirements about," Conditions of storage shall minimize deterioration of the documents or specimens in accordance with the requirements for the time period of their retention and the nature of the documents or specimens. A testing facility may contract with commercial archives to provide a repository for all material to be retained." 21 CFR 58.190 (b).
It's a wonderfully vague section to chase you around with these issues.

The offsite storage vendor only mentioned the service when asked by our auditor. The service had never been discussed before with me or anyone else in the organization by our vendor. The storage is underground cave storage which means temperature and humidity ranges are very consistent and good for records. Paper records should have at least  30% humidity most of the time to prevent deterioration. I think we would miss out on some of the benefit of the environmental pluses of air movement and humidity found in cave storage. Someone mentioned to me in a direct email if this is really an issue, vault storage(like for electronic media) might be easier anyway. Especially since sprinkler fire systems aren't used in that area. It would be much more expensive though.

I spoke to the facility manager at our CRC(Commercial Records Center) and he mentions the clients who are wrapping boxes work with GLP(Good Laboratory Practices) in Europe. In the USA these standards are set by the FDA. Apparently, there is some standard in Europe which mandate shrink wrapping and tarps to cover pallets of boxes to prevent water damage from sprinklers and even covers or gutters around the sprinkler heads. The facility manager felt these measures defeats the whole point of sprinkler protection since they would prevent water from reaching a fire among the boxes in storage. Most sprinkler systems activate individual sprinkler heads  as the fuse melts from heat. Water damage is a lot easier to manage than burned up records.

They use random shelving at our CRC so tarps are generally pointless since their client boxes are rarely shelved together. That would explain the reason for the clients individually shrink wrapping each box. I expect it's an EU regulatory body or a regulation specific to Germany. Many pharma companies operate in Germany and I know they have strict regulations although I don't know them specifically. Does anyone know this European Standard?

Just because something is wrapped in plastic doesn't mean it won't get wet. Most people have learned that lesson if you have ever gone camping and it rained.

I think all the points made by everyone are valid and very good and will help me out. It's an only an observation. I don't have to take action but I have to create a response. With the help of all of you and our CRC I think I have what I need. I think current economy storage works for GLP records without shrink wrapping the boxes especially if humidity and temperature is good and consistent. What constitutes good humidity and temperature management is one of my other battles. I am fairly well versed on that one and I have it covered. I might give a poster session on that adventure at an ARMA conference someday. Some of you have already heard that presentation already.

It's really interesting the changing expectations that are coming from auditors regarding FDA regulated records. These changes are coming from auditors from the FDA as well as internal and external client auditors. Thanks again everyone. Where would we be without the records listserv?


Rob Seibolt, CRM
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Records and Library Services
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