Healthcare, IT and Enterprise Software
The investment in IT software has a huge bearing on the above. When a pharmaceutical company uses software for a regulated market like US/ Europe and some of the developed markets like Australia and developing markets like Brazil, the software has to be compliant to the standards as defined by the drug authorities of those countries. Validation is the process of checking that a software system meets specifications and that it fulfills its intended purpose. So, every software identification, procurement and implementation is a very long drawn out process in a pharma company involved in exporting to the regulated markets. To share a small example, installing an Intel based server with NT/Linux OS will take a day. In a regulated environment it will take at least a week. The validation document will run into hundreds of pages with approvals from the manufacturing quality head.
Like every other company, pharma will have a standard ERP, like SAP, which will manage procurement, goods receiving, warehousing, manufacturing resource planning, finished goods inventory, plant maintenance, sales & distribution, collection, finance and accounting, human resource management and others.
In the last few years, pharma industry has been actively working on digitization of the quality and manufacturing areas. There is a huge expectation from the regulators to strengthen data integrity with the use of technology. As far as possible every data point should be directly captured into the system and that data must not be available for manipulation. Once stored, it cannot be deleted or modified and must have audit trail. The guidance states that data should be reliable and accurate, and companies should implement effective strategies to manage data integrity risks.
Towards that principle, Pharma companies have implemented Trackwise software or similar for Quality Management System. This includes the area of Change control, CAPA management (Corrective Action, Preventive Action), Deviation Management, OOS/OOT (Out Of Specifications and Out Of Trend),Market Complaints and Investigation. Any small deviation from the norm such as breakdown of process equipment has to be recorded, root cause has to be identified, corrective and preventive actions have to be implemented within a stipulated time and then you check the effectiveness of the solution based on non-recurrence of the problem.
Also, there is a very strict adherence to SOP (Standard Operating Procedure) in pharma manufacturing. To that effect, every little process will have SOP and they run in 100s. They get updated regularly. Also, the top pharma companies will have multiple manufacturing units across the globe and most of the SOPs are harmonized across all facilities. The regulators expect the same current version of SOP to be available across all relevant locations. Paper based SOPs have a huge issue where you could end up having an older version in one of the facilities. To avoid that, companies have implemented DMS (Document Management System) where the SOP and Spec STP (Standard Test Procedure) are created online, through workflow the documents are verified and digitally approved and then are made available online for viewing and training purposes.
Every employee in manufacturing and quality goes through a minimum 10-15 training sessions in a year. Some of the deviations’ root cause could be due to lack of training. Before operating any equipment, there is a lot of training. Every SOP has to be operationalized post training and assessments have to take place. Hence, all the training and assessment records have to be available digitally to the regulators.
IT plays a major role in IN PROCESS QUALITY TESTING using PAT (Process Automated Testing) using probes inside a blender. PLC data from Equipment like cartonator, blister packing, filling machines in the area of capsule/liquid/vial filling are extracted to monitor productivity and efficiency of equipments. Also, with the increased risk of counterfeiting of medicines, high speed track and trace of packaging lines have become order of the day. Drug Supply Chain Security Act (DSCSA) is coming into effect in the US where product identification, verification and tracing will have to happen across the entire supply chain where IT has a very important role to play.
In the area of new product development, pharma companies will have 100s of drugs in the various stages of development. R&D investments run into Rs 1000 crore and above. Delays to launch can lead to huge losses of market share. Hence, IT plays a major role in monitoring where each drug is in the development process and regulatory approvals. The package design, wordings and the leaflet inserts have to be strictly aligned to the approved documents up to the pixel level. The entire process of design, verification and approval is done using software like Karomi or Goose technology where certain countries need package to be compatible with Braille.
IT’s sphere of influence has grown multi fold in a pharma organization over the last 4-5 years. IT has successfully made major contribution in the area of Productivity, Efficiency, Data Integrity, Regulatory Compliance and Patient Safety.