The life sciences and pharma industry is by nature a heavily regulated one. As these companies are becoming more data driven and are entering the digital business it becomes more complex to store, manage and use all of this content in a compliant way.

For example the management of product labels and related information is required to meet the regulatory requirements. Future industry trends like ‘Quality by Design’ and ‘Data Trending’ require a holistic view on all content related to products and processes.

Access and interpretation of this data and content is not easy. Regulated control can be even problematic. Deloitte’s ECM services for Life Sciences and Pharma combine industry knowledge with content management expertise to ensure companies are able to use the huge amount of data they generate and to capitalize this and use it as the value-adding asset it is.

Pharma and Life Sciences processes are often content driven and this content serves as a key part of their value chain. Increased productivity can be realised by automating these processes and offering tools that enable document collaboration, easy access, search and secure storage.
 

Document Management solutions
 

• Allow for easy creation and editing of content in a collaborative setting through versioning and shared workspace.
• Make content easily searchable which encourages knowledge sharing and avoids duplicate efforts.
• Assure that information is accurate and recent (“the single version of the truth”): this is achieved by implementing review & approval processes which may include electronic signatures for regulatory purposes.

Deloitte has extensive experience in implementing these ECM solutions; in the design process we work with you to facilitate productivity & collaboration while keeping governance & compliance front and center.

We help our clients capitalise on existing intellectual property and reduce system boundaries in support of more streamlined processes along the business value chain. We use Regulated Document Management to adequately respond to the ever increasing regulatory requirements from the authorities and local, European or global regulatory agencies.

These regulatory requirements include:

• Records management: documents need to be kept for a certain amount of time before they can or must be destroyed
• Discovery: both during the normal product lifecycle and in exceptional cases like law suites, your company may be asked to produce certain information; if not done right, this could lead to significant costs for your company including the cost of having to go through 1000s of documents, the possible penalties linked to producing too much or too little information and the damage this could do to your brand

Content Management Systems can track & manage all your company’s content (both digital and in paper form) to actively reduce your company’s risk.

To drive innovation and collaboration in this knowledge-driven industry it is crucial that you are able to access & share content and expertise across your internal and external network. This will foster innovation and maximize the return on your intellectual capital. The Deloitte ECM practice combines technology with processes and a culture and change approach to grow towards effective knowledge management.

Collaboration with partner organizations

Besides security and compliance to regulators we can help to offer secure collaboration platforms to easily work together with your partners like CMOs and CLOs. Through detailed authorization models access can be given (and restricted) to specific parts of your content management system without compromising your Intellectual Property or competitive edge.