In this article, we touch an anachronistic oddity of the (bio-)pharmaceutical industry: Despite our increasingly digitalized world, many organizations in the industry either shy away from or struggle with the controlled management of electronic documents – especially small and medium-sized enterprises. At QBDC GmbH, we seek to fill this gap with our affordable, yet powerful Document Management System “TEMIS”.
It is not uncommon that an organization relies on a homebrew documentation system for their GMP documents which is
- not validated,
- uses a system which does not comply with relevant regulations,
- or decides to skip the digital requirements entirely by resorting to a paper-based system.
All three options are far from ideal, but often stem out of necessity; insufficient systems, which fail to comply, result in findings and rejections after audits and inspections, outdated and paper-based systems complicate everyday work procedures when filing and retrieving documents, and they are often inefficient as they require more work hours to be maintained, require a lot of space for storage, and require a significant logistical effort, if an organization is spread out on multiple buildings or even countries.
And a fourth option, to invest a six-digit amount into one of the few compliant solutions is simply not feasible for many organizations, especially for small- and medium-sized enterprises.
The result is a major competitive disadvantage for all organizations without an adequate documentation system. Such organizations are less flexible and have less control over their business-critical documents.
Why are there so few validated solutions for biopharma?
The governing regulations for software in the industry, which concern GMP procedures, demand traceability and require a clear interface with Quality Assurance. Now, traceability and regulatory compliance are not terms which are unheard of outside the (bio-)pharmaceutical industry, but upon closer inspection, the terms often comprise different meanings in different industries. There are thousands and thousands of Document Management Systems (short: “DMS”), but only a negligibly small number complies with – or is aware of the existence of – “Part 11”, (i.e. Title 21 CFR Part 11), the FDA-made industry standard for electronic records and electronic signatures.
Part 11 Compliance
Compliance with Part 11 means software validation. This implies: Every line of programme code, every function, every button, every input field needs to be tested, recorded, and eventually reported as functional. All sorts of eventualities must be considered with a risk-based approach and any deviations from the expected results must be either justified or – more commonly – reassessed and corrected. This means, the more complex a software gets, the more extensive and drawn-out the validation process becomes. Software validation can become a bottomless pit rather quickly. And for most software developers outside biopharma, a Part 11-compliant validation is likely not worth the costs and efforts.
Those few developers which have the means to perform a validation on their systems or already have a validated application like SAP, Sparta Systems (“TrackWise”) or OpenText (“Documentum”) may provide exactly what is required, but most of their offers are directed at large organizations and entail technological investments and extensive employee schooling, which often exceed the needs and means of many small and medium-sized organizations.
Going the extra mile to validate an existing software solution is comparable to develop a new one from scratch, thus, it seems as if the extra effort is only profitable at a large scale. We at QBDC believe that this is a fallacy. A GMP-compliant DMS can be capable, compliant AND affordable at the same time. TEMIS proves this.
What is TEMIS?
With TEMIS, we have developed a software solution at QBDC, which allows organizations to keep up with the competition. TEMIS is in its core a database for document metadata, but goes far beyond that. It does not stop at simply recording references and keywords of documents, it also moves, removes and modifies actual files in the background and enforces GMP-compliant document workflows.
TEMIS is highly customizable in regards to document attribution. Before installation, we sit down with the customer to work out the optimal documentation and document attribution system (if none exists) or adapt TEMIS to the existing one. This ensures that no extrinsic documentation system is forced onto the customer.
TEMIS also comes with an audit trail functionality, which tracks changes of critical document attributes and keywords, by recording content, date and time of change and the user who performed the change. Here as well, the audit trail is customizable, so that a customer may define which attributes are deemed critical.
The main reason why TEMIS is so cost-efficient and why the validation remains doable, is its integration into Microsoft Office. It is not a standalone software but is instead embedded seamlessly into existing Excel installations in the shape of several user level-dependent toolbars – so-called “ribbons”.
With TEMIS relying on Excel architecture, the inner workings of Excel proper do not need to be tested and reported again, “only” what is added with TEMIS – which is still a lot but cuts away a significant portion of testing.
It also means, new TEMIS users do not require lengthy training courses to understand the handling of the software. Almost everybody knows how to use Excel, thus, work with TEMIS can start almost immediately after implementation. And for the organization, this means, Excel is likely already part of the infrastructure, thus, no further investments are required to make TEMIS work.
TEMIS is available for purchase at an annual licencing fee. A demonstration may be arranged upon on request. For more information about the inner workings of TEMIS and related offers, visit qbdc.ch.