Connecting the Dots in Life Sciences: Part 3 – Binders


Electronic Binders: Access everything you need in one place.

The evolution of Quality Management System (QMS) platforms is happening now.  Life Sciences organizations need the flexibility of a cloud-based, ready-to-use solution with fully integrated features to support a company’s quality operations at every stage of its growth in manufacturing.

When the QMS lacks integration with other IT systems (e.g., ERP, LIMS, MES, CRM), quality teams struggle to bring together all the information they need to make informed decisions.

According to McKinsey, the average investigation and closure cycle time for a complaint is around 60 days”. This is no surprise considering the time and effort it takes for a quality team to manually assemble and analyze various documentation from all relevant departments, systems and process flows related to the complaint. In a manual environment, there is also the risk that the team will miss a critical piece of the puzzle if they don’t know where to look. 

Conversely, within a holistic, ready to use, pre-configured QMS featuring interconnectivity to all relevant systems and processes, a quality team can simply create a binder to electronically collect and centralize documentation around the product itself (e.g., master record, history record, history file).

For example, the electronic batch record from the MES can be included in the binder for information on how the product was manufactured and connected to forms that were filled out when executing the batch (e.g., test results, set up of batch machinery). All documentation for that specific batch is housed in one electronic place for easy access and analysis when the need arises, such as in the event of a deviation, complaint, or audit. 

Because it is electronic, the quality team can also easily export the information within the binder to parties outside of the organization. One use case for this capability is the regulatory approval process for a new product when a company must compile all product related data into a dossier for regulatory submission. The quality team can assemble the information for the dossier within a binder housed in the QMS and send it to a regulator electronically. 

To stay competitive, Life Sciences organizations need the latest digital QMS features and processes that extend quality oversight into manufacturing. Electronic binders can be leveraged to stay organized and compliant so whether they are managing a Corrective/Preventive action globally, across multiple sites or facing an external audit for a regulatory body, all the supportive data can be found in one place, quickly and efficiently.

Quality 4.0