Why Quality teams need to prioritize data privacy and confidentiality
Worldwide, regulatory bodies impose strict rules to ensure that sensitive data related to cGMP, cGCP, and other GxP operations are handled with the highest level of care. In fact, a single failure to maintain data privacy could lead to severe penalties.
This means that for Quality teams, the stakes are high. Your quality management software likely holds private records like patient data, intellectual property, employee information, and more. That makes it critical to understand, review, and regularly update your data security protocols within your quality management tools.
By doing so, you protect not only the future viability of your organization but also the patients and customers who rely on the safety and efficacy of your products.
eQMS security best practices
It’s one thing to say you take data security seriously, but protecting your data means staying alert and being proactive with data management. Take data privacy a step further with these QMS software security best practices:
- Review access permissions regularly: One of the weakest points of data security lies within access control, which often involves manually adding and removing user access. (Remember, all manual processes carry some risk of human error.) This is especially true for CROs, which may quickly increase or decrease their staff based on changing site volumes. Mitigate this with regular reviews or audits of eQMS access permissions checking that each role can access only the most necessary information. To make this process easier, use an eQMS that allows for user grouping by roles and access permissions.
- Conduct intrusion detection monitoring: Your team likely assesses any security alerts in real time, but a more thorough, regular review of all system logs provides added reassurance. On a weekly basis, comb through your logs to make sure no anomalies or threats slipped through the cracks or were incorrectly categorized. If you do find an error, it’s time to take a closer look at your security processes and permissions.
- Ask about data storage and recovery: While the Quality team plays a role in eQMS security, responsibility also lies with the eQMS vendor itself. Whether you’re looking for a new system or are perfectly happy with your current platform, take time to ask where sensitive data such as patient information, test results, and proprietary details are stored. Also confirm which protocols are in place for business continuity and disaster recovery to prevent data loss.
- Ask about security incident reporting: It’s never pretty, but mistakes happen – and when they do, you want to know about it. Ask your eQMS vendor about their procedures for identifying, documenting, and communicating any data security incidents. Get specific and ask about their incident response time, what level of incident requires customer notification, how they notify customers, and what steps they take to mitigate damage. Just as important as a vendor that can prevent incidents, is one that’s transparent, honest, and fast acting when they occur.
- Pay attention to certifications: Any eQMS you choose should be as intense about data privacy as you are. Read and understand the security certifications below -- and confirm your electronic quality management system actually has them.
eQMS certifications and standards to know (and require)
Data security is a complex world, and it can be difficult to navigate alone (especially if you don’t have an IT background).
Thankfully, the Life Sciences industry has agreed to a set of standards that prove an eQMS is compliant with data security and privacy best practices. The following list may seem like a lot, but when you’re handling sensitive patient or company data “risk averse” is the name of the game.
ISO 9001:2015
This is the internationally recognized standard for Quality Management Systems created by the International Organization for Standardization, an agency with representatives from 172 countries.
At its core, it provides guidance on how to mitigate risk, make processes more efficient, and continuously improve quality. It also ensures that a QMS is meeting regulatory requirements.
The “2015” refers to the release year of the most current version, upgraded from ISO 9001:2008. Any eQMS you choose must have an ISO 9001:2015 certification to guarantee the most secure platform.
ISO 27001:2022
Quality management tools house a lot of sensitive data – which is why ISO 27001:2022 certification is so critical. This sets the standard for information security management and provides parameters on how to manage, store, and secure private data.
An eQMS with ISO 27001 certification has proven data risks are mitigated with procedures like risk assessments, access controls, encryption, and more.
SOC 2 Type II
SOC 2 Type II is an audit report that details how a company – specifically one which uses cloud-based storage – handles sensitive data.
As part of the audit, the company hosts third-party inspectors who look at five main components, called the Trust Services Criteria.
These are:
- Security – How does the company protect sensitive information?
- Availability – Can customers easily access important information within the system?
- Processing integrity – When the company processes data, is it accurate, complete, and done in a timely manner?
- Confidentiality – Is sensitive information secured behind strict access controls?
- Privacy – Does the company’s security controls actually meet its privacy commitment detailed in its published Privacy Notice?
When an eQMS completes and passes a SOC 2 Type II audit, it confirms it has the right data privacy and security controls in place to protect its GxP-regulated clients.
21 CFR Part 11
With globally dispersed teams, it’s no longer efficient for companies to rely solely on physical signatures for document approval.
Electronic signatures are now the norm. However, the FDA requires GxP-regulated companies to prove the authenticity of its electronic signatures and the validity of its electronic records, and they’ve mapped out how to do this in the 21 CFR Part 11 requirements.
These requirements set the criteria under which electronic signatures are considered trustworthy, reliable, and equivalent to paper records.
In order for the documents and signatures you manage through an eQMS to be FDA-compliant, the eQMS must adhere to 21 CFR Part 11 guidelines.
Annex 11
Annex 11 comes into play for GxP companies with operations in the EU. It focuses on computerized systems (like an eQMS) and provides guidance on validation, data integrity, risk management, and system access controls.
Though it’s not legally required, compliance with Annex 11 shows your eQMS takes security and risk as seriously as you do, and provides extra insurance that it meets GxP regulatory expectations.
GAMP5
GAMP5 stands for the 5th publication of the Good Automated Manufacturing Practice guidelines, developed by the International Society for Pharmaceutical Engineering (ISPE).
Its goal is to make sure that the computerized and automated systems that are used in manufacturing processes are properly validated and compliant with regulatory requirements.
Organizations that follow GAMP5 are better equipped to mitigate risk, protect data integrity, and meet GxP requirements.
GDPR
The General Data Protection Regulation (GDPR) is a data privacy law that protects the personal data of anyone who lives within the European Union.
It specifies how much data you’re allowed to collect, when you can collect it, how it’s stored, and what you can do with it. Any organization, no matter the location of its headquarters, must comply with GDPR if it processes the data of EU residents.
Even if your organization doesn’t currently process data from individuals in the EU, you’ll want to prioritize an eQMS that’s GDPR compliant in case your operations ever expand.
HIPAA
The Health Insurance Portability and Accountability Act (HIPAA) sets strict guidelines for healthcare related organizations on how they handle Protected Health Information (PHI).
To be HIPAA compliant, a quality management software platform must encrypt PHI data, control access, and ultimately, preserve patient confidentiality.
Data Privacy Framework
The Data Privacy Framework (DPF) provides an avenue for companies to transfer personal data between the European Union and the United States in a way that complies with EU privacy laws. To participate, companies must self-certify to the U.S. Department of Commerce that they follow the DPF's privacy principles, which are enforceable by US law.
Want to learn more about quality management data security, QMS software validation, and quality management metrics? Check out our eQMS 301 eBook: Best practices for eQMS revalidation, data security, and quality ROI.