Issues

• Procedures and product standards are often created in multiple files and often cannot be managed as a single document
• Approval and version control on a file-by-file basis would require many signatures and would make rejected versions visible to everyone

Solution

• Links to multiple documents can be managed together as one (Packaged document functionality)
• Users can only see valid versions

Detailed explanation

There may be times when you want to review and approve documents with many pages, such as product standards, procedures, and manuals, or documents created in different applications (MS-Word, MS-Excel, PDF, etc.), as if they were a single document. Previous document management systems only allowed review and approval on a file-by-file basis, not on a document-by-document basis. In such cases, a single document had to be approved multiple times, making the approval date, effective date, and expiration date of the document unclear.

Perma Document allows you to bundle multiple files together and treat them as a single document for review and approval. In addition, version control and status management are possible just like for individual documents.

Issues

• When creating or updating procedure manuals, it is important to properly manage training records, including the level of understanding

Solution

• It is also possible to set test questions for each procedure manual and restrict access to them unless they are passed (Training history management functionality)

Detailed explanation

GxP requires the documentation of quality manuals, procedures (SOPs), etc., and also requires the keeping of records of training regarding these documents. There are many different documents, and it is extremely difficult to keep records of training for each document (and each version when they are revised).

Perma Document allows you to manage the following for each version of a document:

• Create test questions and send training request emails to the target individuals
• Those who are to receive training will take a test and will be recorded as having completed the training only if they obtain a passing score (if they fail, they will be required to take the test again)
• Training administrators can search and display the training records of each user
• For documents such as quality manuals, it is possible to restrict access to only those who have passed the training for the relevant version

Issues

• I want to let people refer to documents, but is there any way to prevent them from being leaked?

Solution

• Printing and downloading can be controlled based on permissions (Document protection functionality)

Detailed explanation

All documents handled in business, such as product information, customer information, procedure manuals used in work, and personnel information, contain confidential information. If these documents were to be leaked, the company would suffer disadvantages, such as a loss of social trust. In addition to the cases we see in the news, there are probably many near misses that occur in everyday life.

If you want to allow users to view documents even if they contain confidential information, but do not want them to be able to print or download them, Perma Document allows you to freely set whether printing or downloading is possible depending on the permissions.

In addition, by adding information about the viewer and the date and time to the header and footer, you can prevent printed documents from being lost or files from being leaked.

Issues

• There is a risk that old documents stored on a computer will be used for business purposes

Solution

• It is possible to limit the latest and valid documents to viewing on the browser (Document protection functionality)

Detailed explanation

You may have had the experience of updating the procedures used in your work, only to find that you still used the old procedures saved on your computer.

Perma Document prevents old documents from being used for business purposes by displaying them in the browser and not downloading them to the computer.
Even if you view an old document in Perma Document, the signature page and watermark (indicating valid or invalid) are still visible, preventing mistakes.

Issues

• There are disadvantages to using paper documents, such as the risk of losing them, so we would like to switch to using them electronically, but this is costly.

Solution

• Users can easily create formats, eliminating the need for system engineers and reducing costs. Each person in charge takes turns filling out and signing
• Management is possible in accordance with ALCOA+. Change history is also recorded, and data cannot be tampered with (Custom document functionality)

Detailed explanation

I assume you are using a record format similar to that of an application document, where the person in charge fills out and stamps it, then passes it on to the next person, who then adds to the form and stamps it, and then passes it on to the next person. If you use physical paper application documents, you won't know who is holding them and there is a risk that they will get lost. Another issue was that it took time when locations that were physically far apart were involved. Previously, in order to digitize such information, it was necessary to develop a program and create an application for each record format, which was extremely costly.

With Perma Document, business personnel can create record formats with just a few simple settings without having to write any programs. This record is created using a workflow, with each user taking turns entering only the parts they are responsible for. Additionally, users can use electronic signatures instead of seals.

Furthermore, it is designed to be completely tamper-proof, making it ideal for customers who are particular about product/business quality.

Issues

• Managing blank paper forms to ensure they comply with regulations is a huge effort

Solution

• Administrators can easily create blank forms, and staff can enter records with electronic signatures and in a tamper-proof format (custom application function)

Detailed explanation

Data integrity regulations require proper management of blank forms.

1. Creation and approval of blank form
2. Print a blank form
3. To prevent blank forms from being tampered with, assign information to identify each page (such as numbering) and manage their issuance
4. To prevent unauthorized copying of blank forms, have the original signed by QA, use a die-cutting machine, use the watermark printing function of the print driver, etc.
5. Reconciliation of all blank and recorded forms

Both of these controls are necessary to prevent a decline in pharmaceutical quality due to improper recording, but managing blank paper forms to ensure they comply with regulations requires a huge amount of effort.

Issues

• Event management generally requires a lot of cost and time

Solution

• Users can set up workflows and templates, reducing costs (Theme management functionality)

Detailed explanation

Preparations for unannounced inspections are urgently needed. It is necessary to be able to quickly search for and present relevant documents and records when requested by authorities, and to achieve this an event management system is essential.

Building a new one takes a considerable amount of time and is expensive. Furthermore, configuration changes will be required from the next fiscal year onwards, resulting in ongoing costs. When deciding to implement a system, it is common to calculate the costs and quantitative benefits over a five-year period, but the difficulty in determining the benefits of implementation is when compared to the number of people involved in event management work.

With Perma Document, company personnel who are familiar with the business can easily set up business flows and templates after receiving simple training, which allows for a significant reduction in cash outflows and costs not only in the first year but also from the second year onwards.

Issues

• If deviations or changes occur, multiple documents must be created and approved in an organized manner, and training must be managed, but there is a risk of missing tasks

Solution

• Centrally manage the progress of multiple documents. Status is automatically reflected, making overall management easy (Theme management functionality)

Detailed explanation

The essence of deviation and change management work is to clarify what needs to be done and manage progress. Progress management is time-consuming.

With Perma Document, you simply define the documents and events you need, and the progress status will be automatically reflected based on the document's workflow history. This information is designed to be unable to be tampered with by anyone after it is created, so the audit department can undergo inspections with peace of mind without having to check the relevance again.

Issues

• I want to share documents with external parties and leave a record of confirmation (signature) from both parties in the system. Security is also a concern

Solution

• Create users for external partner companies and share documents securely (IP restrictions, encryption, permission settings). Use workflow to record both signatures

Detailed explanation

In today's business, division of labor and collaboration with other companies is essential. In such cases, documents will inevitably need to be created jointly and checked by both parties. Sharing via cloud services has become increasingly common in recent years, but it comes with several challenges.

Perma Document takes these measures.

Regarding 1, we implement measures such as firewall protection and restrictions on source IP addresses. If you restrict the IP address of the access source, only your company and partner companies will be able to access the site. This reduces the risk of unauthorized access.
Additionally, an effective measure to prevent document leaks (2) is to not hand over the information itself to the recipient. Documents can only be viewed on a browser, and we provide a function to restrict printing and downloading.

Issues

• It is inefficient to review the PDF again after sending the original file (Word, etc.) to an outsourcer

Solution

• Automatically linking and managing the original file to your company's rendition server enables timely PDF review (Rendition management functionality)

Detailed explanation

Although approval applications using eCTD have become mandatory, for companies with a small number of applications and who outsource their eCTD work, setting up a dedicated system in-house is a cost burden.

Issues

• Government regulations (data integrity) strongly require the issuance/collection management of record forms

Solution

• Document printing and issuance management is possible
• Print a unique 2D barcode on each page
• Manage reconciliation information

Detailed explanation

Data integrity regulations strongly require management of the issuance and reconciliation of record forms.

As mentioned above, managing records can be quite a hassle.