I’m struggling with what seems a very basic issue within a company where they are using a paper based document management system. As of this week we have implemented that all controlled documents must be signed off by QA and Management (it includes SOPs, Policies, Manuals, Forms, Reports, Plans, Specifications and Templates) it all seems so logical. But the main issue seems that when printing out for example. a form that the first two pages that include the signature sections, and table of contents, this causes a lot of frustration within the company for not understanding the logic behind this. Is there a smarter way to do this without the signature page, yet being controlled.
Thanks in advance
Using a paper based system for this type of control is going to be very time consuming and frustrating and also will lead to compliance issues down the line.
Is there any proposal for implementing an electronic solution anytime soon?
Not at the moment or in the future, so for now they are using this and I need a practical solution.
Understood, let me think about this further.
A possibility is to make pdfs in the place where people print them from. Make sure that only 1 version (the effective one) is available here. The signature page and table of contents is then stored on paper. In the pdf you only add the approved text. By having proceudres that describe this, you still have a paper version, but do not have to print all the time irrelevant pages. The user is resposnible to only use the effective version.
I hope this is helpful.
An option is to have each page initial/date by QA at the time QA approves the document. This is time consuming but eliminate a any chance of error.
It’s possible a stamp can be used that is only available to QA instead of the initial/date.
Any process decided on should be captured in your document control procedure.
All the best!
Can you also print with a time stamp? This can be set up on the print functions. That way when QA and management sign of a document (1st page), the 1st page will also give a date / time / second, and all other pages will have this same traceable information on it. You can tell that QA read and signed off of the document by reviewing the subsequent pages - they all should have the same exact time stamp.
You should also ensure the number of pages is printed on each page. That way you can defend that QA and Management saw all the pages, and that the pages were all present (and not changed out) after QA signed them off.
You would have to do some testing around time stamps printing, to ensure that nobody that purposefully go in there and change the time stamp (to try to sneak in a change to a page, and forge the time stamp).
Not sure if I could answer your question, but wish to share what I have seen in some companies that using paper based management system.
1st) SOP to mention only QA personal can issue forms
2nd) print the form without signature page
3rd) stamp with ‘Authentic’ stamp by QA rep.
But will create more works for QA.
Option 2 :
Put signatures on header/footer, each page has approver/QA signatures and this method shows better control also. From my experience, some ‘creative’ ones might edit the content/fields of the form and replace the own version to the signature pages. It is because to create a standard watermark in word or PDF doc is really an easy task for an IT savvy person. By putting signatures on header/footer might prevent this issue.
p/s: it is more environmental friendly as well
My question is…what is the true frustration?
Is it that the printing of FORMs also requires the printing of the first two sheets (signatures & TOC), or
Is it that the printing of SOPs also requires the printing of the first two sheets?
I use a paper-based system.
For the printing of FORMS, the first two sheets are not “attached” to the form. Signatures are required and maintained, but are not part of the FORM sheets. All of our FORMs are number with both ID and Version numbers, and each form has a Revised Date printed in the bottom corner of the form. We then have controlled binder(s) with all currently approved forms beside each photocopier, which staff can photocopy.
Printing of SOPs is controlled by Quality…and Quality stamps all SOPs as “Controlled Document”. Controlled Copies of SOPs are located where they are used. If a copy is needed to another reason, then Quality photocopies the SOP and stamps it “UNCONTROLLED DOCUMENT”.
Some people do take issue with the amount of Non-Value information in an SOP. If you can, reduce the amount of Non-value info. For example…some SOPs require signature from multiple departments…do this on a separate form, but only have two people sign the actual SOP. If your SOP needs an Table of Contents…then maybe your SOP it too long…and once people are trained…do they need a TOC? Another item people place right in an SOP is the revision history. Again, this is non-value info for people following the SOP. Revision history is very important, and needs to be kept, but is not required by those following the SOP. Save and plus the revision history elsewhere.
That is my two cents.
I think the frustration is being time-effective with a paperbased system.
Paper-based systems take a lot of stamping and copying, and signing or initialing each page. They aren’t elegant, but a electronic document system is somewhat more expensive to set up initially.
Hi @Erikv01, as others have suggested it seems that your frustration is something that unfortunately goes hand in hand with using a paper based system. Providing access to a slimmed down version of each document for printing and keeping another full version for internal/external audits might work but it will create significant management overhead. The same goes for having QA sign each page on newly approved documents.
I’m not sure when the last time you looked was, but there are a new breed of doc control / QMS solutions available for smaller companies that want to leave cumbersome paper based systems behind. That’s why we started Qualio, a web based QMS platform for life sciences orgs with fewer than 250 people. With Qualio not only do you no longer have to worry about additional pages being appended to documents, but in most cases documents don’t need to be printed at all. Our customers range from 3-person medical device startups to public biotechnology companies. The transition is always quick and the benefits of improved compliance, 5x faster workflows and better access to information is immediate.
Of course, the right path will depend on your departmental / organizational goals and strategy, but I wanted to make sure you are aware of other options. Best of luck in your search for a solution.
Thank you all for your perspective on this issue. I have found it very constructive to read your answers and your help on this matter.
For SOPs, Manuals, and policies the systems stays the same. For forms we have decided to start page numbering on the active form (where information needs to be filled in). There is still a link between the not numbered page and the numbered.
We are not a company where QA issues documents and we are not even going to pursue that, however a electronic system as suggested will be an option even for a small company as we are.