Overcoming the challenges of a fragmented quality management system

In the average workday and particularly when many have been working from home, a digital workplace (intranet, team sites, Excel, file shares, calendars, etc.) offers a way to collaborate, communicate, share documents, and effectively produce general information.

The average workday for a company in the life science sector revolves around compliance processes and managing a large amount of documentation about their medical device or product. They must adhere to strict regulatory requirements, compliance, and standards for documentation. Suppose life science companies use the familiar digital collaboration applications as their quality management system (QMS) for documentation combined with other traditional paper documents. In that case, there are some major challenges and shortcomings to consider.

1. Time-consuming management and administration

Compared to other industries, life science companies are under continuous and rigorous scrutiny from different regulatory authorities and organizations such as the Federal Drug and Administration during a product's life cycle, service, and delivery. And there is a good reason for this. Regulations serve to protect people and animals by ensuring the safety, efficacy, and security of different products, including human and veterinary drugs, biological products, and medical devices. In addition, internationally agreed standards set out the requirements for a quality management system (QMS) specific to the industry.

There are mainly two categories of documentation that a life science company needs to control and manage:

  • QMS category of documentation: operating procedures, all the guidelines, procedures, policies, ways of working
  • Medical Device Records (MDR) – documents everything about the product – how it was created/developed, validated, etc.

If documentation spread out over various systems is used for QMS, this requires significant administration and time. Administration will consume numerous works hours to follow up, monitor, and manage the trail of documents in different formats and servers. In addition, the user experience is not optimal since the QMS has a file sharing focus rather than compliance processes. With digital documents combined with paper documents, mailing physical documents, scanning, filing, retrieving, and storing paper records equals manual resources – and there is a higher risk for human error leading to misplaced or lost documents.

Life science companies are liable to provide a secure environment and securely manage all aspects of documentation – ranging from archiving product documentation (10-30 years), creating, updating, signing to deleting documents. However, a combination of disconnected forms of filing, storing, verifying documents makes it hard for employees to guarantee the security of the data.

Download the E-book "Life Science eQMS" for more inspiration

2. Difficulty improving organizational processes and workflows

In a QMS, one of the requirements is to define and demonstrate the company's quality management processes to ensure best practices in everything they do.

With scattered systems, an overview of work processes is missing. This makes it difficult for people to work effectively together and implement new methods or standard operating procedures.

Not knowing what to improve and how to implement organizational and operational efficiencies can also impact the ability to meet standards and achieve certification. Without best practices in place, there is a risk that each person develops their own ways of working, leading to even more disconnected organizational processes that are not very cost-effective and lead to mistakes that might be critical within life science. With all resources centered around managing documentation, processes and achieving certification, the company's ability to shift its focus to customers is limited.

3. Ineffective processes

A vital aspect of a QMS is to support executing processes. Compared to a fragmented QMS, a comprehensive and digital QMS will dramatically increase efficiency, compliance processes for audits, corrective and preventative action (CAPA) management together with risk analysis and management. In addition, data gathering and powerful metrics provide essential insights into the work processes, help prioritize and govern decision-making. Without effective methods, companies will have a hard time advancing their business.

4. Lost company insights and business potential

Although different systems and formats may work for the daily short-term needs for collaboration within a life science company, using them for QMS can have long-term consequences. Insights, learnings, and knowledge sharing during the product's life cycle, which may take many years coupled with staff leaving, are lost – as well as potential business opportunities.

As the company grows in terms of staff and markets, fragmented or deficient documentation systems are more challenging to maintain and are not a cost-efficient scalable solution.

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5. A step behind market needs and competition

As recently witnessed with the covid pandemic, there is a sense of urgency to deliver readily approved medical products to the global market. A life science company with the ambition to meet the market demand quickly must be agile – all processes, documentation and certificates need to be in place. Companies utilizing QMS software designed to manage compliance processes and ways of working will have a competitive edge in delivering their product faster to the market. Workflows are more automated, alleviating the burden of paper forms or utilizing e-signature and gathering data and insights is easier to implement.

Protecting your company's know-how is in the QMS

CANEA ONE offers solutions to help life science companies complement their existing digital workspace tools with a comprehensive QMS suite that scales with your business, makes document management easy and contributes to making work processes more effective. According to Daniel Sten, Vice President, IT Solutions at CANEA, he says,

“Documentation such as procedures and processes are the organization's know-how, and it is vital for life science organizations – it is their competitive edge. The know-how is inside the QMS. That is something you need to make easily accessible and manageable while at the same time, control and protect in a good way. And we can help."