TEMIS – Document Management System

Pharmaceutical and biopharmaceutical enterprises are required to comply with exceptionally high requirements as their products affect the health of human beings directly and indirectly .

Exceptionally demanding is the administration, distribution and storage of digital data and documents. Existing solutions on the market reach costs of six digits rather quickly (whether in $, € or CHF), and more often than not, an enterprise is not willing or unable to invest this amount of money into software.

Thus, enterprises are forced to either choose a cheaper, yet insufficient solution, or are even forced to take a step backwards and resort to a fully paper-based system, which bears risks of financial losses (i.e. documentation system not accepted by authorities) and inflexible and outdated procedures (i.e. inability to efficiently manage, distribute, search and retrieve documents).

Due to this gap in the industry, QBDC has developed the small and affordable, yet powerful document management solution TEMIS.
TEMIS shall bridge a past due way towards paperless documentation and shall at the same time help small and medium-sized enterprises to overcome their competitive disadvantage against fully digitalized big players.

TEMIS by QBDC is a validated and GMP-compliant, yet small and affordable software solution for controlled preparation and administration of digital documents.

Familiarity

Figure 1: Part of one of the TEMIS ribbons, in this case the Manager ribbon. Shown are buttons for creating and moving documents, editing database entries, searching the database, and handling the audit trail.

TEMIS is not a standalone software, it is embedded seamlessly into existing Excel installations with a number of so called “Ribbons”.
Ribbons are toolbars, which are added to the existing menus in the Excel interface (see fig. 1), just like the ribbons “insert” or “data”. This way, TEMIS users experience familiarity and aren’t forced to adapt to an entirely new software concept, new workflows, new procedures, which significantly reduces time and effort for training and adapting standard procedures. And for the company this means, the required infrastructure for TEMIS is mostly almost available, thus, additional investment costs can be kept low.

The functions of TEMIS are divided into four ribbons, which reflect the four different user roles with varying permissions. The TEMIS Administrator is capable to perform structural changes to the database, such as adding new attributes or new doctypes, and is thus capable to unlock and lock the additional security measures that are in effect by default. Of course, in a GMP environment, structural changes are only allowed with an approved change control order.

The Manager handles document distribution, the assignment of document numbers and responsible persons, and is allowed to create new and modify existing entries. Similarly to the Administrator, a Manager is only allowed to perform document changes on released documents, if a respective change control order is issued (or the affected document is non-GMP), including creating new revisions and archiving outdated or invalidated documents.

Figure 2: (video without sound): This short video gives a quick once-over of some basic TEMIS functionality: A new document is created by the Manager, then assigned to a Key User, who then starts entering persons to the list of approving parties.

The Key User serves as the role for document authors, editors, but also for reviewers, approvers and trainers. A Key User is able to edit and change documents while they are being prepared, and is responsible to feed the database with the respective document’s metadata. A Key User can also access finalized documents in write-protected folders during the approval cycle or during training.

The User at last, is granted a rather limited database access and may only access released documents in a write-protected folder.

Accessibility

Figure 3: This shows what TEMIS does in the background when documents advance in their respective workflow steps. Files are moved/copied/removed, depending on the step. If another GMP type than “GMP-ATE” is selected (e.g. to file an external or a non-GMP document), some steps are automatically skipped.

Even though TEMIS relies on Excel architecture, it is much more than a complicated Excel workbook. Apart from its use as a document metadata database, TEMIS goes beyond simply recording metadata by directly referencing, accessing, modifying, and moving the associated digital files.

This means, when a document is moving forward in its workflow, for example when a document is finalized and ready for approval, then TEMIS not only changes the document's status in the database, it actually moves the finalized files from an editable directory to one that is write-protected for most users so that the approvers cannot change the document anymore.

Once a document is released (i.e. “effective”) it may then be distributed via the write-protected TEMIS directories, available to all users with granted access permissions. It may also be distributed in the traditional way via a QA-guided procedure with controlled paper copies.

In other words, TEMIS goes far beyond a basic Excel functionality with some formulae and cross-references to other files, it is a powerful file administration and distribution tool.

Workflow control

Figure 4: This simplified schematic shows the workflow of a GMP document, which is initiated with a change control order, then prepared, reviewed, approved, trained, and finally released. If there is a previous revision of the document, it is taken out of circulation and archived, before the new revision is released. All steps in the light green rectangle are performed in TEMIS, only change control and trainings are to be performed externally. However, future TEMIS updates foresee addons for both, as well as a feature for the use of electronic signatures.

TEMIS is in its core a database for document metadata, but it is also a management tool, which helps its users to maintain control over their documents by applying GMP workflows from inception until archiving.
During these workflows, TEMIS users can easily extract information or entire files from project- or process-relevant documents in order to write reports, build entire dossiers or look up information, such as work instructions or test results.

TEMIS follows common GMP workflows to the letter for the entire document life cycle (see fig. 4) and provides control over who is responsible, what was changed and when, what is the document’s progress or status, where can it be found etc. It also allows quick access to user-defined range of documents via filtering and a TEMIS-specific search mask (see fig. 5).

Figure 5 (video without sound): This shows the basic functionality of TEMIS’ search feature. We are looking for documents which contain the string “doe” in the “author” attribute AND “invoice” in the “document name/title” attribute.

TEMIS tracks customer-relevant information in audit trails, which ensures that sensitive changes are only performed with a justification. The collected information in turn can then be used for periodical audit trail reviews and for inspections.

GMP-compliant and validated

TEMIS is a validated software according to Title 21 CFR Part 11, (short: “Part11”), which is the FDA regulation (and the industry standard) for electronic records and electronic signatures. No other competitor we know of offers a part11- and GMP-compliant solution at this price range and with that degree of flexibility. This makes TEMIS a unique in the industry and a potential game changer for small and medium-sized enterprises.

A complete validation has been performed by QBDC, and for the remaining validation tests, which can only be performed at the customer on-site, a guideline, instructions and checklists will be provided.

For example, if the customer has already established a documentation system, then no new one needs to be created, but QBDC may assist in adapting affected documents to be in line with TEMIS.
If no proper system exists, QBDC may provide basic documents (such as information on documentation procedure requirements, backup and file security requirements) to give the customer a head-start in building their own system.

It is possible to use TEMIS in a non-validated environment (at university institutes or R&D enterprises). This will require no qualification tests at the customer on-site, and several compliance requirements (audit trail tags, user rights management, GMP workflows) and implications (QA-controlled environment with change control, training and documentation SOPs etc.) may be deployed only to a degree deemed necessary, or even ignored.

TEMIS Packages

Could we spark your interest?

We offer TEMIS in three different packages. If you would like to know more or would like to get a specific offer, please follow this link so we can get in touch with you.

You may also click on one of the “Get Offer!” buttons below.

* Not included in the annual fee is a single payment of initial implementation costs. These costs can only be roughly estimated because they depend on the state of the future customer's documentation system, of the IT environment, and of the QA-controlled procedures.
QBDC estimates the implementation costs at roughly the same price as the first yearly payment.
Implementation includes, but is not limited to, the customer-tailored document types, attributes, and audit trail conditions, and the adaptation or preparation of affected/required procedures.

Requirements

The following requirements are needed for TEMIS to work:
  • Office 2010+
  • Windows operating system
  • Administrated file server for TEMIS directories (preferably Windows-based)
  • User rights management appliance such as Active Directory, Azure, Sharepoint etc. on said file server.

Downloads

TEMIS comes with an in-depth manual, which is freely available for download.

During validation, QBDC has performed a part11 assessment. It may be used to prepare your own system to meet the requirements for TEMIS

One of the core building blocks of TEMIS is the so-called “Attributes Matrix”. Before installation, a company is advised to define their own matrix according to this template.