Pressure to bring new products to the market faster has never been greater. At the same time, records and information’s management is growing more challenging by the day. For pharmaceutical companies, efficient records and records management are a central part of demonstrating GXP compliance. Even as the use of electronic records grows, physical records continue to play a critical roles in every stage of the product lifecycles. From Research and Development and clinical trials to regulatory approval, manufacturing, quality assurance, sales and marketing - effective records management matters.
Many pharmaceutical companies depend on a combination of tools to track their records - using custom-developed software that is difficult to maintain; on legacy tools from vendors that are no longer updating their software and on spreadsheets.
The hidden costs of this are profound. Too much staff time is spent manually entering information on multiple systems. It can also take a long time to track down records as they change custody. Furthermore, delays in tracking down and retrieving records can mean unnecessary delays in responding to regulatory audits, which can in turn trigger warnings and significant fines.
Streamlining Pharmaceutical Records Management
Finding the physical records, you should be as easy to finding your electronic documents. And with more staffs spending more time working remotely, it saves time to be able to search for the physical records you need without having to send an email or submit queries in person each time.
Modern pharmaceutical records management systems should enable the Records, Quality and Information’s Management teams to easily:
· Centralize information on physical records and electronic information
· Restrict access to information’s to authorized users only
· Automatically track chain of custody
· Captures a complete record of all activity
· Manage and apply records retention schedules
Benefits of an effective Records management for pharma industry
· A central source of documents from pre-clinical to post market stage makes search, retrieval and update of documents easy.
· Improved information sharing with external bodies
· Improved data quality due to automation
· Improved information security by restricting unauthorized access
· Enhanced and easy access to stored records and information assets
· Workflow automation helps easy flow of information between internal and external stakeholders based on rule-based routing to determine needed activity
· Reduced redundancy and duplication of information
· Regulatory compliance by creating audit trails of access and activity performed on stored information