Adventures in quality management: how document control became sexy

adventures_quality_managementIn the past, document management was an unglamorous business. Not every company was digitised, and those that were were often struggled to create frictionless governance systems. This is the story of how a new kind of software changed the face of document control.

Some of the first software to digitise document and quality management made for clunky user experiences. They often seemed divorced from the real-world problems they were intended to solve and the way people actually wanted to work.

When governance tools are frozen out

When long-standing Cognidox client Chris Hill first arrived at the British Antarctic Survey as a project manager in the 1990s, he was tasked with managing some of the world’s toughest engineering challenges.

chris_hill_pragmaticBut at that time, he recalls, the BAS was working with an on-premise document management system called ‘Objective’ - a centralised governance tool that the organisation hoped would improve efficiency. 

Spoiler: it didn't. As the software was released, a familiar story unfolded:

“There was a lot of publicity and communication about this. We all had training. We all tried it once. We all went back to using shared drives.”

Chris Hill, Pragmatic - keynote speaker at Cognicon 24

Following all the hype, the team in the Antarctic found it made their admin more complicated and gave it the cold shoulder (if you'll excuse the pun).

QMS software uptake is not guaranteed

There’s a moral to this story.

It’s all very well developing a single digital repository for your technical and quality documentation, but getting people to actually use it, is another challenge altogether.

Trying to improve governance with digital systems can end up simply as box-ticking exercises for compliance that don’t actually change behaviour.  

At worst it can end up adding layers of bureaucracy that cost your company tens of thousands of pounds, while actively disrupting your business momentum

Can document control ever be 'sexy'?

With eQMS that could take months to install while siloing quality management functions, the men and women tasked with enforcing governance could just be seen as nagging jobsworths, sniping from the sidelines, spoiling everyone's fun.

This was the unglamorous, sharp end of project and quality management:

  • Imposing the approval workflows that no one seemed to want
  • Policing ‘one-size fits' all processes that seemed to create MORE friction
  • Insisting on the form filling that everyone hated
  • Chasing signatures and counter signatures to prove compliance
  • Slowing down the 'real work'

The cost of poor governance rises

These were the tensions that plagued dedicated quality teams intent on imposing order in large organisations.

But the age of digital spawned a new breed of agile, start-ups working in the high-tech and life-science sectors. The fail-fast, iterate-hard values of the dotcom boom gripped many companies, but for some, the risk and cost of poor governance became all too obvious.

Rupert Baines, founder and CEO of numerous semiconductor companies, describes the dawning realisation in tech start-ups during the 2000s that chaotic documentation was impacting quality performance and client satisfaction

The rise of challenger eQMS

But, luckily, a new breed of quality management tools were being developed. These were platforms that were cloud-based, faster and more configurable than their predecessors. They were specifically designed to connect the everyday digital collaboration of agile developers, with the business and quality management tools that could accelerate their process and control business risk.

How document control became ‘sexy’

This software was easier to handle and configure compared to the clunky on-premise platforms that went before.

Developers with unique products and ways of working could be given the flexibility to set up their own phase gates, approval sequences, and validation procedures. They could do precisely what they needed to ensure compliance while avoiding over-processing

In doing so, whole businesses were able to make their governance fast and LEAN, while collecting all the compliance documentation they needed to share with regulators.  

And everyone could see the business effect take hold in terms of faster process, less waste and less stressful audits.

Cognidox makes quality the ‘way you do things’

The Cognidox eQMS was designed to deliver precisely this level of support. Providing a robust framework for digital document control, it still equips businesses with the essential tools needed for governance in high-risk industries like medical device development. 

At the same time, it offers the flexibility to adapt to existing workflows, ensuring that teams don’t need to overhaul their processes just to fit in with the software.

Cognidox makes compliance frictionless

Chris Hill who (after leaving the Antarctic) began working in biotech and then in semiconductor development, found just this kind of freedom with the Cognidox tool.  

It was a revelation to him that digital, quality management could be so frictionless:

Cognidox makes document control work for you

Across different sectors the experience of Cognidox users has been the same. The sense of freedom and control that comes from its configurability - answers the governance challenges that face many organisations attempting to handle compliance.

For example, the Newcastle Cancer Centre Pharmacology Group used Cognidox to digitise sign off regulated documentation - and the whole organisation immediately felt their processes accelerate:

Cognidox brings stress free audits

For others, like Jonathan Wyn Beer of medical device developers Sandoz, the Cognidox eQMS was different from anything he’d experienced before in the sector.

At Sandoz he found ISO 13485 auditing no longer needed to be a stage-managed process with a ‘war room’ in the background, but could be conducted in real-time just with the available Cognidox tools:

Successful exits with Cognidox

For other companies, Cognidox has become a driving force behind successful exits.

Rupert Baines argues much of the discipline in governance that underpinned his multi-million dollar sale of Ultrasoc to Siemens, was the organising influence of the Cognidox platform:

Conclusion

Quality management and document control were never the ’sexiest’ part of a corporate offering.

But as eQMS platforms like Cognidox have enabled faster ways of working and less onerous governance - many businesses have begun to take notice of how they can transform a business from plodding workhorse to powerful thoroughbred.

eQMS platfoms that were once seen as cost centres or just a nerdy necessity by many, have now become visible within companies as real engines for commercial success. 

For Chris Hill, Cognidox has become more than 'just another platform', it's become the lifeblood for managed innovation within successive companies he's worked for.  So, let's leave the last work to him.

“I can't ever recall in my life being excited about a piece of software until I came across Cognidox."

Chris Hill, Pragmatic

 

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Tags: Document Management and Control

Joe Byrne

Written by Joe Byrne

Joe Byrne is the CEO of Cognidox. With a career spanning medical device start-ups and fortune 500 companies, Joe has over 25 years of experience in the medical device and high-tech product development industries. With extensive experience in scaling businesses, process improvement, quality, medical devices and product development, Joe is a regular contributor to the Cognidox DMS Insights blog where he shares expertise on scaling and streamlining the entire product development cycle, empowering enterprises to achieve governance, compliance, and rigour.

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