6 unique challenges of life sciences compliance

6 unique challenges of life sciences compliance

In the highly regulated life sciences and biotech industry, companies are forced to comply with countless rules and regulations. The complexity of regulatory requirements has increased sufficiently over the last few years and is expected to grow even more in the future. Understanding the requirements and the regulatory standards is the key.

Life sciences and biotech companies face enormous challenges to respond to this increasingly complex regulatory environment.

To remain compliant, organizations need to understand:

– The risks of non-compliance

– How technical document compliance can be implemented

–  Which compliance challenges will emerge in the future

What are risks of non-compliance? 

While life sciences and biotech companies are pushing the boundaries of innovation to develop new products, they are struggling to meet industry regulations. The continuous tension between meeting business goals and regulatory compliance is a major challenge, especially in an industry where the risks of non-compliance are stringent.

Failing to comply can lead to:

–  High fines and economical damage

–  Remediation costs

–  Reputational damage

Additionally, life sciences companies have a big responsibility in preserving patients’ lives. Non-compliance can pose a threat to the health and safety of patients. Companies should understand the complex regulative landscape and integrate a single, enterprise-wide view of compliance risks.

How to avoid FDA RTF refusal to file and technical non-compliance

You can find out more about the risk of RTF and how modern rendering helps avoid it in our other blog post.

What are the unique challenges of life sciences compliance?

The development of quality management and compliance programs are essential to manage the regulatory compliance challenges in the life sciences industry:

–  Be prepared for regulatory inspections: Regulatory controllers always come by surprise, so make sure your internal processes and documents are permanently ready to prove ICH, FDA and ISO compliance. Continuously ready models are efficient and limit compliance costs.

–  Hire compliance talent: A company with an extensive compliance structure will win the war for talent with well-matched compliance skills.

–  Encourage an ethical mindset: Instead of focussing on rules, companies should recognize and reward compliant behavior. Embedding ethics and integrity in the DNA of the company proves to be a critical success factor in the life sciences and biotech industry.

–  Engage the regulators in the innovation process: A good relationship with compliance regulators is important as they come up with a lot of compliance challenges. By engaging them into the innovation process, you limit the risks of non-compliance.

–  Use data analytics to identify compliance risks: Most life sciences companies have access to extended historical data. By analyzing this information, they can predict future compliance risks.

–  Share compliance expertise: As the regulatory landscape in the life sciences industry keeps expanding, companies need more compliance resources. By sharing compliance expertise, organizations can ensure compliance standards will not be compromised.

A company that approaches compliance as a source of value instead of merely an insurance policy for risk, can use it as an important competitive advantage.

Establishing an efficient quality management system

An effective and future-proof compliance system goes hand in hand with an efficient quality management system. With the compliant rendering solution from DocShifter, companies can use one centralized solution to establish, update and certify their quality management system.

This is how DocShifter simplifies regulatory compliance for the life sciences industry:

–  It easily converts any input format (Word, Excel, PowerPoint, PDF…) automatically to ICH-, FDA– and ISO-compliant quality documents in PDF format.

–  One centralized solution that provides a perfect integration with Content Management Systems (CMS) and other business systems.

–  It automatically assigns the digital documents to any folder, mailbox or CMS.

–  High availability and load balancing characteristics enable the processing of extremely large volumes of documents.

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About DocShifter

Speed, quality, scalability, and configurability are reasons why biotech, pharma and medical devices companies choose DocShifter to automate and simplify all their document conversion processes. From automatically checking and fixing Word and PDF documents to generating compliant, submission-ready PDF renditions, DocShifter software offers a unique and proven approach to speed up time-to-market.

High volume, high-quality document conversion, on-premise, or in the cloud. Super easy to set up. Automate. Centralize. Eliminate manual intervention. Reduce Risk. Reduce IT infrastructure costs. Rated 5 stars on Gartner’s Capterra platform.

Bonus: We created an FDA PDF format specifications checklist for you, so that you can identify content-related issues as soon as possible to reduce the risk of RTF.

You can download the checklist here.