In recent years, document management has become a growing challenge for many of the pharmaceutical companies that are our clients. In many cases, the number of regulated documents that pharmaceutical companies hold is growing to unmanageable levels. It is not unusual to see a single company with several thousand regulated procedural documents.
These large document portfolios are not only expensive to maintain, they can also be a real “Pandora’s box” when it comes to compliance risk. How can employees be expected to achieve familiarity with every single procedural document? How can organisations be sure they don’t have two documents that contradict each other? After a regulatory change, which documents will need to be updated?
Improving document management is key
While regulations, and therefore regulated documents, are a fact of life for pharmaceutical companies, it is poor document management and ineffective governance of the documentation portfolio that results in the unsustainable proliferation of documents. For example, pharmaceutical companies will often add new documents to the portfolio without assessing their impact on the existing document set. Similarly, they may not question whether a document meets the dynamic needs of the business or ask whether new processes or regulations can be incorporated into existing practices.
By establishing an end-to-end shared service with a unified governance model, which we call a ‘document factory’, we have found that pharmaceutical companies can reduce their regulated document portfolio by 50% and reduce related operational costs by 40% within the first year.
Benefits of establishing a document factory to improve document management
Improving document management by establishing a document factory creates benefits for pharmaceutical companies by:
providing a scalable approach to adapt to changes in the volume of work
enabling the quick remediation of large and complex document portfolios
creating immediate and effective governance oversight across the documentation portfolio
establishing a platform to enable successful management of multiple stakeholders
educating others on best practice approaches towards streamlining the documentation portfolio.
A document factory comprises the following elements:
a centralised, dedicated team of experts across key business areas that assesses the organisation’s regulated documentation, ensures alignment to industry and company standards, carries out on-going document maintenance and looks for opportunities to improve the portfolio, such as by reducing the number of existing documents
capabilities in process modelling, documentation architecture and authoring, training design and implementation, and change management expertise to develop and implement required documents
a management framework that outlines accountabilities for facilitating decision-making and determining priorities.
To find out how PA helps pharmaceutical companies achieve compliance and cost benefits through more effective document management, please contact us now.