The 3Cs of a good quality management partner

A checklist to help you choose a GxP compliance partner
Our friends at MonstarLab hit on 3 key qualities you should look for in a quality management partner. This article shares their insights on what pharmaceutical, biotech, and medical device companies should look for when selecting a strong GxP compliance partner.

GxP compliance is imperative for all businesses in the Life Science industry; and for good reason – to protect consumers like you and me. But some companies are doing better than others at ensuring food and product safety and data integrity. What’s their competitive edge? A well-rounded partnership with advanced compliance needs providers. And we’re breaking down what you should look for in a GxP compliance partner into the following 3Cs to help you get in on that advantage.

Comprehensive services

First and foremost, find a prospective partner that can provide all of your compliance needs across your product or service life cycle. Selecting a partner with end-to-end services covering the central pillars of GxP – safety, traceability, and accountability, will not only create a more seamless regulatory process flow but also save your business as much as 1,300 hours in time and labor costs from executing compliance initiatives in silos yearly.

In your search for a partner, look for these offerings:

  • IT System Selection and Bridging: This employs a highly structured approach that ensures you integrate the right digital system that supports both regulatory requirements and your business priorities and strategy.
  • Technology Validation: With rapid developments in technologies such as Artificial Intelligence (AI), Robotics Process Automation (RPA), and the Cloud, this offering can catalyse your adaptation of new technologies in the heavily regulated industry.
  • Quality and Compliance Assessment: Process assessment can give you transparency into your compliance efforts to enable quick adaptation and implementation of new regulations. Evaluation of operational safety, serialisation, data integrity, IDMP, MDR/IVDR, UDI, 21 CFR Part 11, and ISO standards, among other qualifications, make way for the optimisation of efforts across entire organisations.
  • System Maintenance Management: To ensure compliance post-implementation, the process involved makes sure your systems are continuously in control and improved. Whether your IT systems are on-prem, hybrid, or in the cloud, this step in the cycle supports and safeguards your operating systems efficiently.

Complete certifications

To further gage the capabilities and ensure the qualifications of your choice GxP compliance partner, take a good look at their institution-awarded certifications. More often than not, these certifications are a reliable measure of a company’s proficiency and abilities in different compliance categories. Take advantage of them to fast track your partner evaluation process and to make more sound decisions in your selection process.

Before signing any contracts, look for these important certifications:

  • The Health Insurance Portability and Accountability Act (HIPAA): Certification of compliance to this proves that your chosen provider meets all privacy and security requirements surrounding medical data and information.
  • ISO 27001, 27017, 27018: These certifications indicate that a company promotes information security with their practices and ensures safe and secure management of facilities.
  • SOC 1, SOC 2, SOC 3: SOC 1-3 certifications protect data controls surrounding confidentiality, availability, security, and overall privacy preservation.

Continuously updated strategies

Last but not the least, consider if the candidate compliance partner actively makes an effort to keep up with or, better yet, get ahead of the times. Chances are, lack of consistent reform in their standard compliance strategies translate to higher risks of non-compliance. A simple inquiry on the novelty and timeliness of their approach to compliance as well as the codified standards they follow can save you from choosing a compliance partner that’s stuck in the past and paying for jurassic programmes.

Though taking these extra steps into consideration can seem tedious, being diligent and attentive to these 3Cs can bring you a rewarding partnership that ushers you into the competitive compliant edge. Together with an all-around partner, you can make GxP work to your competitive advantage and fast track all the opportunities technology has to offer.

Are you ready to bring compliance expertise to your Life Science company? Ensure you keep these 3Cs in mind so that you can choose the perfect partner for your needs.

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Charlotte Pærregaard

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