Guys

I need guideline for archieving documents coming from diffrent department I never had opprtunity to work with Document control management system How do I suppose create archieving numbering system which expedite tracking of all record. Please not my concern working in pharmaceutical company follow regulation. documents such as method validation, raw material, chromatogram etc.

Thanks in advance

:(

Hello, Class!

Please, let's make sure I understand your question. You are in (or going to be in) a job in a pharmaceutical industry. They generate all kinds of documents, and you are wanting to establish some type of archiving system. Is that accurate?

Do they not currently have some kind of archiving system?

What method are you talking about with archiving? Are you going to scan and store them, or are you talking about storing/filing hard copies of the documents? I would think most documents would have some kind of number on it already-equipment number, study number, batch number, etc. Is that what you are talking about?

I guess I don't clearly picture what you are wanting to do. When you get a chance, offer a few more details so I can try to help.:)

How do I suppose create archieving numbering system which expedite tracking of all record


Depends on what you want to track

You have used the term record, I would imagine that the records you produce already have an identifier either through a form number or record number.

For example if you are going to archive a Device History Record, the batch the record relates to will have a number e.g. 123ABC20080304, where 123ABC is the batch number, and 2007 (year) 03 (Date) 04 (month) is the date manufacture started.

This number will be unique to a specific batch that was produced.

So if you are packing into boxes prior to storage you will need a unique number for the box that the record is stored in and a means to identify what is in each box, this is usually a database or spreadsheet.

for other records e.g. paper nonconformances, again each one will have a unique number, but in this case and perhaps others (e.g. closed CA's or PA's) you may want to consider filing in batches that are sequential (e.g. non conformances for a specific number range) this will make retrieval easier (when you open box the NC's will be in numerical order opposed to random).

what essentially you need to consider is:

a) The unique identifier must be something that is understood by all so if someone ask for a DHR it is clear to you/your staff what they are asking for.

b) A system that you can interrogate to locate requested items (database/spreadsheet)

c) A submission process so all understand how to submit records to your group filing (an archive submission form that they complete)

d) A request process so all understand how to request items (an archive request form)

e) A procedure/process document that descibes the process.

f) Work instructions that Archive personnel use to perform archiving that provides instructions for consistency when archiving

g) A chase system for documents taken but not returned, on the request form you add an area for requestor to specify how long they require documents with a default of 2 weeks, this willl help you know what to chase and if something is lost or damaged.

h) Confidentiality, certain records you may wish to restrict access to e.g. HR records (which should come into you sealed, make this part of the process)

Other factors you may also want to consider are

1) if you archive off site a barcoding system linking documents. boxes, locations I set up something like this with a storage supplier so when they came in they scanned contents and boxes removing arguments about what had or had not been taken.

2) if you are scanning documents the sytem in place for holding documents and providing access to these scanned documents.

I could go on but I think this will give you an idea of the requirements for archiving.

cheers Nigel

Hello, Class!

Please, let's make sure I understand your question. You are in (or going to be in) a job in a pharmaceutical industry. They generate all kinds of documents, and you are wanting to establish some type of archiving system. Is that accurate?

Yes that's correct

Do they not currently have some kind of archiving system?

yes they don't have anything currently any system



What method are you talking about with archiving? Are you going to scan and store them, or are you talking about storing/filing hard copies of the documents? I would think most documents would have some kind of number on it already-equipment number, study number, batch number, etc. Is that what you are talking about?

I am refering about storing/filing hard copies of the documents and they alreday have numbers, notebook number ,study number etc.

I guess I don't clearly picture what you are wanting to do. When you get a chance, offer a few more details so I can try to help.:)

Please read listed answer as follow

Please, let's make sure I understand your question. You are in (or going to be in) a job in a pharmaceutical industry. They generate all kinds of documents, and you are wanting to establish some type of archiving system. Is that accurate?

Ans. yes I am workin in a pharmaceutical and it does all kind of document

Do they not currently have some kind of archiving system?

Ans. No they don't have any kind of archieving system

What method are you talking about with archiving? Are you going to scan and store them, or are you talking about storing/filing hard copies of the documents? I would think most documents would have some kind of number on it already-equipment number, study number, batch number, etc. Is that what you are talking about?

Ans. I am refering about storing/filing hard copies of the documents. yes Most documents would have some kind of number on it already-equipment number, study number, batch number,

Often, you can find a lot of answers within your organization - if you know where to ask or bothered to ask around.

For records, check with your accounting people -especially the accounting clerks. They would already have a system to store/archive, keep track and protect accounting records, though often these procedures or method were not documented. Over this part of the world where we follow British practices, accounting records need to be kept for a minimum of 7 years and they need to be produced anytime for checking or investigation purpose.

Similarly, secretaries or administration people have good filing practices for documents and records. In fact most of the current practices in the ISO world were adapted from what they had been doing all the while.