Requirement(s) for Fireproof Cabinets for Storing Batch Records
- Thread starter SGquality
- Start date
Re: Fireproof cabinets for storing batch records
Hi,
There is no such specific regulatory requirement, unless someone can point it out.
Most modern regulatory systems require that such records are "maintained" or the likes. How you do it is a matter of risk management.
Cheers,
Ronen.
Hi,
There is no such specific regulatory requirement, unless someone can point it out.
Most modern regulatory systems require that such records are "maintained" or the likes. How you do it is a matter of risk management.
Cheers,
Ronen.
M
maaquilino
Re: Fireproof cabinets for storing batch records
There's no specific requirement for it. But essentially, records need to be saved for their specified retention period and protected from deterioration and loss - and that could come from such large things as flood, fire, natural disaster, to smaller things such as someone who removes a file from a cabinet and never returns it, or brings it to their desk and spills coffee on it. It’s up to the company to ensure their records are protected from this. Several QMS procedures can speak to this: Document Control, Control of Records, Backup and Recovery, Disaster Recovery.
This is true for both hard copy and electronic records. I’ve seen a lot of companies throw their hard copy files in an unlocked filing cabinet and forget about them; many times when they go to look for something – usually during an audit – they can’t find what they’re looking for because someone walked off with it. Same thing with their electronic records; they put them in some file on the network and then nobody remembers where it is, what it’s called, and if it’s a network drive that is actually being backed up. Those records are part of the history file of a product, whether during design or production. Not having them when an auditor comes looking can cause numerous problems for a company, up to and including recalls.
Companies who want to ensure their records don’t get lost or destroyed will sometimes use fireproof cabinets to store records inhouse or in a separate building; many do this as part of the disaster recovery process. It’s a small price to pay to ensure they can not only get up and running again faster but that they will have the records needed to meet production and compliance needs. Many companies I’ve worked for kept all documentation, including records, onsite in fireproof cabinets for a period of time (usually no more than 2 years); then they were shipped off to Iron Mountain. In the Global Quality department, we also had a procedure for handling electronic records, which included not only having them backed up on the server (which had a failover server and several other backup and recovery options), but we made several CDs of the documents: one to go with the hard copies, one to go to the global quality dept, one to go to the head of the dept running the system.).
FDA's CFR 820 (820.180 General requirements) state:
All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections. Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by FDA employee(s). Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those records stored in automated data processing systems shall be backed up.
ISO 13485 states:
4.2.4 Control of records
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. The organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than two years from the date of product release by the organization or as specified by relevant regulatory requirements.
There's no specific requirement for it. But essentially, records need to be saved for their specified retention period and protected from deterioration and loss - and that could come from such large things as flood, fire, natural disaster, to smaller things such as someone who removes a file from a cabinet and never returns it, or brings it to their desk and spills coffee on it. It’s up to the company to ensure their records are protected from this. Several QMS procedures can speak to this: Document Control, Control of Records, Backup and Recovery, Disaster Recovery.
This is true for both hard copy and electronic records. I’ve seen a lot of companies throw their hard copy files in an unlocked filing cabinet and forget about them; many times when they go to look for something – usually during an audit – they can’t find what they’re looking for because someone walked off with it. Same thing with their electronic records; they put them in some file on the network and then nobody remembers where it is, what it’s called, and if it’s a network drive that is actually being backed up. Those records are part of the history file of a product, whether during design or production. Not having them when an auditor comes looking can cause numerous problems for a company, up to and including recalls.
Companies who want to ensure their records don’t get lost or destroyed will sometimes use fireproof cabinets to store records inhouse or in a separate building; many do this as part of the disaster recovery process. It’s a small price to pay to ensure they can not only get up and running again faster but that they will have the records needed to meet production and compliance needs. Many companies I’ve worked for kept all documentation, including records, onsite in fireproof cabinets for a period of time (usually no more than 2 years); then they were shipped off to Iron Mountain. In the Global Quality department, we also had a procedure for handling electronic records, which included not only having them backed up on the server (which had a failover server and several other backup and recovery options), but we made several CDs of the documents: one to go with the hard copies, one to go to the global quality dept, one to go to the head of the dept running the system.).
FDA's CFR 820 (820.180 General requirements) state:
All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections. Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by FDA employee(s). Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those records stored in automated data processing systems shall be backed up.
ISO 13485 states:
4.2.4 Control of records
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. The organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than two years from the date of product release by the organization or as specified by relevant regulatory requirements.
Y
youngm
Re: Fireproof cabinets for storing batch records
What about "prevent deterioration or loss of documents"? Should you be scanning everything and putting it on a network or document management repository where it is backed up. And if you keep the paper copy, do you only store in fire proof cabinets and then send off to an Iron Mountain? Are there ways I'm not thinking about to add to Control of Documents Section 4.2.4 for ISO 13485:2016?
What about "prevent deterioration or loss of documents"? Should you be scanning everything and putting it on a network or document management repository where it is backed up. And if you keep the paper copy, do you only store in fire proof cabinets and then send off to an Iron Mountain? Are there ways I'm not thinking about to add to Control of Documents Section 4.2.4 for ISO 13485:2016?
