Although high-profile data breaches grab the headlines, behind the scenes, life sciences is just as information sensitive as any industry. Any pharma company faces a major challenge when it comes to complying with the myriad regulatory requirements about how they create, handle and submit documentation about the products they manufacture.
Even a minor slip up can have a serious financial impact in the form of fines, penalties, or delayed product launches. With so much at stake, document management is a critical process for any pharma companies.
There are a number of widely-accepted best practices to ensure compliance with regulations, but many of these are extremely complex to implement, meaning that the industry has struggled for years to put them in place. These include:
- Harmonizing and standardizing all global regulatory submission templates
- Keeping on top of changing and emerging requirements and timelines
- Implementing strong versioning and change management practices
- Maintaining strong governance and process management controls
- Capturing key performance metrics and feedback from regulatory authorities
At Syntel, our prescription to these challenges is a suite of end-to-end regulatory services, driven by an intelligent regulatory services platform. We combine the power of automation and decades of business process expertise to implement standardized, trusted processes for regulatory operations and submissions to health authorities. We can deliver business outcomes such as:
- 20% reduction in regulatory writing and submission publishing time
- Dramatic improvements in submission quality
- Consistent templates for all clinical documents
- Easier document lifecycle management
A huge added benefit to more structured and consistent document management is the ability to capture rich metrics at every step in the process. By making the document initiation, preparation and publication process more transparent, we can deliver deep insights into your operations and make continuous process improvement a reality.
If you are ready to take the next step in your document management operations, visit us online at https://www.syntelinc.com/industries/life-sciences.
Imran Sheikh is Sr. Consultant, Regulatory Affairs at Syntel. He has over 10 years of rich...