At a recent knowledge sharing and networking event in London, England, life science industry professionals gathered to glean insights from experts on the common challenges experienced in implementing effective quality systems.
While there were many important points made, the one consistent takeaway was that the key to practical QA and compliance is the reduction of waste.
This ultimate truth was expressed in a variety of ways across the various presentation. The following offers a snapshot of how a broad range of businesses and consultants see the importance waste reduction in the life sciences industry:
Digital shreds paper… and outdated systems, too
Stellan Ott of Wolfram Ott & Partner, a software company that manages the weighing of ingredients for pharmaceutical manufacturing, needed a dynamic, accurate, traceable quality system. The nearly six-year undertaking entailed applying Capability Maturity Model Integration (CMMI) based processes to automate validation activities and reduce other types of waste through the application of various agile software (Scrum) methodologies. Using the Microsoft team foundation server as the electronic platform for the project, Ott and his team managed to substantially reduce waste by eliminating repetitive, mundane administrative tasks, allowing developers instead focus the majority of their work day on development.
Today, thanks to the new system, Wolfram Ott & Partner routinely passes GXP audits with flying colors and has also experienced a positive overall shift in corporate culture.
Busting release documentation bottlenecks with the right digital platform
RadBee founder, Rina Nir, uses Jira and Confluence as the operational backbone for many projects – especially for those clients engaged in software development, which demands detailed, compliant release documentation. The possibility to configure these tools to support virtually any business process make them the perfect platforms for life sciences companies’ eQMS, including the review, approval and usage of controlled documents. From the automation and streamlining of “read & understand” trainings on an enterprise scale to a “one button creation” of release documentation, the powerful combination of Jira and Confluence mimizes time, effort and resources and makes it possible for companies to release fast and often.
Resisting change is the ultimate waste
Making large shifts, for example to paperless validation, is monumental – and for many companies, change is seemingly impossible. Consultant Markus Roemer is expert in guiding companies in innovating their systems so that compliant digital validation can happen now… and in the future. In his work, he frequently sees teams cling to outmoded QA practices. Markus cautions that if you hear someone boast about how their company uses GAMP5 for QMS (which is so large that nobody actually uses it), brag that their process was approved by the FDA (who doesn’t approve processes) or even that their system is 21CFR certified by their vendor (such certification is not possible), then you know you’re dealing with an organization that’s officially stuck. Empty claims aside, the truth is that all that’s needed is a solid digital Computer Systems Validation (CSV) process and a cultural shift to move from paralysis to productivity.
Digitised design control = DHF sustainability
Today, every stage of a regulated development cycle, from first submission through ongoing, annual or semi-annual iterations is critical. From delays to audit failures and recalls, challenges to timely product releases and updates abound. Want to preserve the integrity of your release, while at the same time streamlining and accelerating it? Laurence Sampson of Siemens recommends a closed-loop digital development cycle . Digitised design control is the key for a smooth launch to ongoing updates, and all points in between. This message was reinforced by Carl Pullen, from Cambridge Design Partnership, who shared his experience with using Siemens Polarion to do requirements engineering for a big pharmaceutical company.
Data integrity & quality saves resources – and lives
Nowadays, data integrity and data quality must co-exist in order for organizations to be effective, efficient, and sustainable. This may sound logical, but when the various gatekeepers get in the mix – all of whom speak a different language and have different priorities – reason often goes out the door, and along with it, the successful launch of many life-saving technologies. But, as consultant Keith Williams notes, this common challenge can be turned into a massive opportunity for life science companies to vastly improve their business efficiencies by implementing a company-wide, paperless CVS that includes an integrated collaboration platform.
Mind the gap: compliance is your bottom-line business game changer
In 2017 Epista Life Sciences pioneered a novel methodology that actually measures compliance in pharmaceutical, medical devices and biotech companies. According to Klavs Esbjerg, CEO and founder of Epista, the findings were telling: the same company that believes it “documents everything” – presumably to convince regulators that they are compliant – often doesn’t anchor their quality systems to anything that’s related to the actual processes. Compliance challenges ultimately are business opportunities: in fact, 75-percent of the companies Epista surveyed said regulatory requirements take precedence over business requirements and overrule business requirements, also at a strategic business level. Their bottom line recommendation? Life science companies must focus more on their processes and better integrate quality management departments to ensure they’re aligned with both business and compliance requirements. This allows organizations to quickly and easily pivot to focus on meaningful issues, for example, responding to price pressures and regulatory compliance, or overcoming technical challenges such as adapting cloud-based solutions, integrating AI, etc.
In the end, all of the contributing experts agree: old paper-filled environments need to be tossed in the dustbin, and new, facile digital methods must be employed by modern life science companies who want to remain competitive.
If you enjoyed these highlights and takeaways from our recent event, Practical Solutions in CSV and SDLC for GXP & MedDev, please contact us. We are planning future events now and will keep you posted. And please feel free to let us know what topics you’d like to see covered as it relates to devising and maintaining an effective eQMS.