Compliance Management: How 4 Companies Simplified the Complex
Regulated industries have a very important responsibility to meet and maintain compliance. This confirms that products and processes meet standards that ensure quality and safety — which in some cases could save a life.
What is Compliance Management?
Compliance management is the process by which regulatory compliance is met and maintained. It includes everything done to plan, organize, document, control, audit, and enforce activities that ensure compliance.
Clearly, it is important for regulated companies to be diligent in their compliance management. Here are some great examples of how some businesses cut costs and improved efficiency by transitioning out of manual processes.
Compliance Certifications in Record Time — Fractyl
Fractyl Laboratories is a biotechnology companythat brings curative therapies to patients with metabolic disease.They developed a minimally-invasive procedural therapy, Revita™ duodenal mucosal resurfacing (DMR) —which is designed to rejuvenate the lining of the duodenum and improve patient health.
Fractyl has to adhere to a number of medical device regulations, which means they need traceability.
Like many other businesses, Fractyl originally managed requirements in Microsoft Word and kept issues in Jira. Using these two separate tools, there was no automated way to get traceability between requirements, issues, and tests. They would have had to create a trace matrix with Microsoft Excel. But this manual process wasn’t a sustainable process as requirement sets got larger.
“But it’s a very manual process to maintain a traceability matrix in Excel,” said Ann Rossi, Senior Software Quality Assurance Manager. “I’ve been there. I’ve done that. And I knew I had to find a better solution.”
Fractyl decided to use Helix ALM to manage their requirements, tests, and issues — a tool that automatically creates end-to-end traceability.
By transitioning from a manual process to Helix ALM, Fractyl achieved several compliance certifications in record time, including the CE Mark 12 months ahead of schedule.
Compliance Management System that Supports Agile — Sennheiser
Sennheiser develops and manufactures innovative headphones, microphones, and wireless transmission systems. They have to comply with several countries’ regulations regarding signal interference, electromagnetic compatibility, and other safety concerns.
Years ago, Sennheiser also used manual methods — like tracing in Excel — to manage requirements, issues, and test cases across their development processes. By switching to an ALM solution, they gained a better overview of the risks and regulatory concerns they must address.
But traceability wasn’t their only concern. Some teams wanted to transition to . They needed one tool that would let all teams work the way they wanted, yet still act as a single source of truth.
Because of the way their ALM solution works, teams were able to configure their workflows to work the way they do — without losing the traceability necessary to compliance. All products can use the same platform to share information, even those working on complex, multi-technology products.
Project quality managers and testers love the possibilities “to create test cases and document the results of repeated tests in test runs. Reporting capabilities for test campaigns are also appreciated.” — Hartmut Gohdes, Product & Quality Manager, Sennheiser Electronic GmbH & Co. KG (Sennheiser)
Secure Hosting, Easy Customization, Fewer Costs — XL Capital
For XL Capital, compliance management is a global initiative within each of its three divisions: Insurance, Reinsurance, and Financial Products and Services.
XL Insurance used a manual tracking system consisting of a series of spreadsheets to manage defects. However, as more applications needed to be managed, the spreadsheet system became impractical and unreliable. An employee familiar with Helix IM wanted to use Helix ALM to track compliance issues and manage the process workflow.
As a result, they found that not only did the Perforce software meet all of its criteria for a tool, but also the license fees were a fraction of the cost of those in their alternative solution. Additionally, it was vital that the solution was hosted on-premise.
“Helix ALM’s workflow support was a key factor in its selection and was easy to install and customize, which meant little, if any, third-party consulting would be required.” — Doug Alexandar, XL Capital
Easy Audits with Easy-to-Use Compliance Management System —TALX
TALX provides HR compliance management for businesses of all sizes. TALX chose to pursue SAS 70 certification as a competitive advantage, and to provide customers complete assurance that their data was secure. Consequently, they needed to manage compliance efforts without significantly increasing head count or pulling resources away from core business efforts.
When considering ALM solutions, they chose a tool that has cross-platform capabilities, scalability, and is also easy to use.
Because of Helix ALM’s configurability, TALX did not have to re-engineer their process. And they saved the cost of a half to full-time employee they’d have needed with an internal tool.
“It is easy to provide an auditor with the requested documentation,” said John Williams, Director of Compliance. “I simply generate a standard detail report provided with Helix ALM. That report displays all the actions taken on a change in chronological order from the initial request through the final certification by QA.”
Stay Compliant with Regulatory Compliance Management
For many companies, compliance and regulatory teams are separate from development teams. So when regulatory changes occur, it can be difficult to address all the impacted requirements. If you have to comply with regulations, even those like GDPR, it’s helpful to know how to set up SOPs and automation to make the process easier.
Download the white paper to learn these best practices.