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The Latest from Our Expert Consultants

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/ Rahul Bhatia

AS OUR WORLD GETS MORE DIGITAL, YOUR SPREADSHEET BASED QUALITY PROCESSES NEED TO ADJUST

In today’s society, with the almost countless number of software applications for quality systems, it’s foolish for any company serious about regulatory compliance and achieving quality within their processes and products to continue to use the spreadsheet based systems of old to manage any of their quality processes. This is especially true when small to medium businesses, and even the larger companies within the industry, can opt to implement electronic quality systems. Electronic quality systems provide a more cost effective platform to store, manage and retrieve data and records than these spreadsheets could ever accomplish. This applies to all quality process tracking applications utilized in the pharmaceutical industry, ranging from deviation investigation (non-conformances), corrective actions / preventive actions (CAPA), change control (change management), internal and external audits, and the list goes on and on.

Here are the main areas where you will see the most benefit: 

Permissions - Enterprise level applications allow for structured visibility and in app reporting platforms that will respect user permissions. Often the requirements are not for everyone to be able to to see every record or all the data within a record of an organization’s quality management system. Data privacy, and data sensitivity can be respected based on how you configure the permission set ensuring that those that need to see records or data see it through their specific group permission. Look to a consulting partner that has built systems where multiple memberships and levels of permission are built in – for example, for supplier or external access where based on designation of records you see information and data. 

Data Integrity - This is one of the most critical points and justifications for why you should move your spreadsheet or pen paper quality process to an enterprise system. Validated applications will support additional controls and measures including audit trails, to help and ensure that your data is reliable, accurate, and maintains data integrity throughout its lifecycle.  In 2016 alone the FDA and regulators estimate that at least 38% of all GxP non-compliances were due to data integrity issues. 

Broader Analytics - Enterprise applications allow for the ability to trend on multiple sets of data through a holistic view of your quality processes. Gone are the days that the only sets of data you could see were based on specific siloed processes. Nowadays, we see management teams in life science companies demanding IT to provide the ability to see trends and metrics across an entire quality system platform rather than a siloed specific quality process. Common business requests are, “Let us see how many critical Quality Events or Issues were noted rather than only deviations, or non conformances, or audit observations. Allow us to monitor how a supplier is doing based on our audits of them as well as reported non compliances and CAPAs.” This is the type of information that is going to provide clearer visibility allowing key and insightful business decisions to be made. 

Data Integration - How much time and error is realized by your organization when your team is manually taking data out of one spreadsheet only to put it into another? One of the largest advantages we see in electronic quality systems over spreadsheets is the ability to interface multiple individual applications into one comprehensive, compliant and efficient quality management system. This day and age of connectedness, web services, and API’s now allow integration and interfaces between different systems with ease, relatively quickly and efficiently. 

Automation - Notifications, dates, and business rules – never miss a beat on due dates on key KPIs and metrics that you need to run your business. Allow additional automations that will take on the leg work that was before being manually performed by your team’s resources . For example, a client came to us with a six sigma effort to automate processes. Our team was brought in to define logic and create a solution that automates portions of their complaint intake increasing process efficiency and reducing manual effort. The automation provided the ability to assess their complaints by searching different data sets in different systems to make critical business decisions. 

Standardization -  As companies expand into multiple regions and globally, the need to standardize the processes cross functionally where possible becomes so much more important. Having an enterprise level system allows you to  ensure that processes are being controlled and followed the same way throughout and no one person or team is always left responsible or bottlenecking the access to the data. 

Performance & Efficiency – As your data and record needs get larger, the time it takes to process the information and generate any reports or metrics of value basically ‘time out’ for excel sheets. 

Cost Efficiency – Users and resources spend less time searching for stuff and trying to pull out any useful insights or information. This translates into saving man hours and having your resources be more productive. 

In summary, whether you are a large or small firm, take advantage of the benefits that transitioning your current paper & spreadsheet quality processes to an EQMS offering. Reap the full benefits that these digital technologies will have on your business and quality activities including saving time, money, providing operational efficiencies and gaining insight into your business for the long run.  Leverage a consulting partner that has specifically designed solutions for organizations that have made the the move from the spreadsheet process to enterprise quality systems. Spreadsheets and paper processes don’t always map ‘exactly’ to or translate directly into an enterprise system so find a consultative partner that will be thoughtful of the critical design elements and successfully allow you to join the digital transformation that is happening all around us.