Records Retention Schedule

How does one get started creating a records retention schedule?

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Hi Stephanie!

That is a great and also loaded question!

One of the first things to do is talk to people in the affected departments and see what retention schedules they might already have in place, they may just not be using that terminology. For example most HR departments have a timeline for how long they keep certain documents, as do groups like the Tax and Accounting departments. Getting your arms around what is already being done is a good place to start.

You also want to be sure you or someone from your Records Management team is included in the conversations that are occuring around retention…if it’s a bullet point on monthly department meetings, make sure you’re there or at least available to answer questions, hear what people are saying, and provide your input into the process early on.

Remember too that bigger is better when it comes to a retention schedule…look for the “big buckets” when you’re picking your categories and subsequently their rules. This can be a challenge as it’s pretty easy to find reasons to segment things down to their most granular level, but do your best to help guide the decision-making process towards fewer categories that will be easier to manage. Every organization is different, so there’s no one right way to do things.

The actual plan is relatively simple to put in place…it’s basically going to be your list of categories, and then within each category, the rules that apply to that category. Rules can be things like setting a cutoff date, a disposal date, or a transfer date. If you don’t have a huge list of categories, setting the list up shouldn’t take too long.

Then it’s time to categorize your actual records. This is where it can take much more time, depending on how many documents you have and how you go about applying the categories. You can of course apply the categories manually, but that can be very time consuming and also leaves a lot of room for human error. Using an auto-categorization program can help you there. The most important thing to remember is that no records management happens until the categories you create are applied against the actual records!

I would love to hear from our other community members here about the best practices, tips and tricks, and “gotchas” to avoid that they have encountered!

Again, thank you for your question and for being a member of RMU!

Michael

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It can be very helpful to use an existing File Plan or Retention Schedule as a starting point.

If you search “retention schedule filetype:xlsx” on Google, you’ll come back with 11,700 results of other organization’s retention schedules in an Excel file format, which you can use as a starting point.

For example, the second result is from Great Falls College, and it’s a pretty nice document:
http://www.gfcmsu.edu/about/policies/documents/GFCMSU_Record_Retention_Schedule_2019.xlsx

Great question, thank you!

Richard

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Thank you. I am trying to find retention periods for pharmaceutical GMP documentation. Having difficulty finding a place to start since the company I am working for has no idea what documents they have nor how to handle their retention. Where may I look for these types of documents?

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I believe the laws for GMP retention are definied by 21 CFR 211.180:

211.180 General requirements.

§ 211.180 General requirements.

(a) Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or, in the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under § 211.137, 3 years after distribution of the batch.

(b) Records shall be maintained for all components, drug product containers, closures, and labeling for at least 1 year after the expiration date or, in the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under § 211.137, 3 years after distribution of the last lot of drug product incorporating the component or using the container, closure, or labeling.

© All records required under this part, or copies of such records, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred. These records or copies thereof shall be subject to photocopying or other means of reproduction as part of such inspection. Records that can be immediately retrieved from another location by computer or other electronic means shall be considered as meeting the requirements of this paragraph.

(d) Records required under this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records. Where reduction techniques, such as microfilming, are used, suitable reader and photocopying equipment shall be readily available.

(e) Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures. Written procedures shall be established and followed for such evaluations and shall include provisions for:

(1) A review of a representative number of batches, whether approved or rejected, and, where applicable, records associated with the batch.

(2) A review of complaints, recalls, returned or salvaged drug products, and investigations conducted under § 211.192 for each drug product.

(f) Procedures shall be established to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions, are notified in writing of any investigations conducted under §§ 211.198, 211.204, or 211.208 of these regulations, any recalls, reports of inspectional observations issued by the Food and Drug Administration, or any regulatory actions relating to good manufacturing practices brought by the Food and Drug Administration.

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FDA actually has an entire book about Records Management, Data Integrity, and Data Compliance for GMP documentation:
https://www.fda.gov/media/119267/download

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Thank you for this information! I am working from scratch, so these guidances and resources will come in handy.

Thanks again to a great RM community!

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