Regulatory constraints hinder digitalization

The Critical Role of Digitalization for Compliance in Healthtech and Medtech.

Regulatory standards are one of the main barriers to adopting new technology.

audit trail, compliance, digitization, regulated standards

According to a study by France Biotech, regulatory constraints are the most significant concern for 28% of French Healthtech* companies and the second biggest concern for French Medtech companies in 2023*.

These figures highlight the challenges companies face in highly regulated sectors that seek to innovate while complying with regulations.

This observation is paradoxical: regulatory standards represent a significant obstacle to adopting new technologies; however, computerized management systems and the digitization of business processes are becoming essential to ensure regulatory compliance for companies subject to stringent regulations.

Regulatory standards regarding computerized systems

Regulatory standards may seem daunting and challenging to interpret, especially in highly regulated sectors such as the pharmaceutical industry, biotechnology, finance, cosmetics, or transportation. Standards proliferate from various sources: government, regulatory bodies, or international standards.

3 major regulatory standards

ISO 27001: an international standard describing best practices for creating an Information Security Management System (ISMS).

It is based on four essential criteria: availability, integrity, confidentiality, and traceability of data and services.

21 CFR part 11: The standard issued by the FDA (Food and Drug Administration) and targeting industries in the life sciences domain is focused on managing electronic records and signatures (ERES).

It aims to secure data and ensure its integrity and traceability
GDPR: General Data Protection Regulation. It concerns companies established in the European Union or offering products and services in the European territory. The regulation aims to hold organizations processing personal data accountable and protect users’ rights.

Many other specific regulations depend on the sectors and regions of the world.

At GxpManager, our data centers are ISO27001 certified. Our applications enable companies to comply with the 21 CFR part 11 standard. We adhere to GDPR: Our application makes it easy for businesses to comply with native built-in features.

A persistent paper-based culture

Given the numerous regulations concerning computerized systems, many companies continue to rely on paper-based processes despite technological advances. It is tempting to stick to these practices: they work, so why change? A signed paper document is the best way to ensure legality and that digital solutions present hacking risks.

However, in highly regulated sectors, paper no longer ensures regulatory compliance. Digitalization becomes essential to ensure the traceability, security, and integrity of data required by regulatory standards.

Digitalization: the solution to regulatory compliance

Digitizing data is the best solution to ensure regulatory compliance. Let’s see how digitalization allows compliance with the three critical points of all regulatory standards.

Traceability

Data digitalization enables data traceability throughout the product lifecycle, from creation to archiving.

Each data modification or transfer is recorded through audit trail tools: user identification, date and time of action, type of modification made, or any other information to be traced.
Each significant action must be validated by electronic signature.

Audit trail tools greatly facilitate audits: companies equipped with digitized data management systems can provide documented evidence that all actions taken on the data are traced. Besides compliance, the audit trail saves valuable time compared to manual methods.

Data Security

Computerized systems allow fine-grained access management: only authorized employees can access data.
Stored data must be encrypted and automatically and redundantly backed up to prevent loss and falsification.
Data security involves highly secure data centers. Various security systems exist, including fences, video recordings, and limited and controlled access.

With GxpManager, you can rest assured that our data centers are highly secure. Data is replicated and regularly backed up to prevent loss.

Data Integrity

Digitizing data reduces the risks of human errors: with a paper form or a spreadsheet, the user may forget to fill in a field or fill it with the wrong type of data. A digitized system can make fields mandatory to complete the action or define the field type beforehand (date, numbers, free text, etc.).

Digitizing data reduces the risks of fraudulent manipulation, particularly data encryption, access control, and traceability through the audit trail, adding electronic signatures authenticating each user. Therefore, with every action traced, it is easy to ensure that a document has not been modified since its signature.

Agility is a real asset for maintaining compliance

It is essential to choose an agile solution capable of quickly adapting to regulatory changes and integrating with other systems to ensure long-term compliance. In selecting a solution, it is essential to remember that it is up to the solution to adapt to your constraints and not the other way around.

In a changing context, where regulations tend to evolve to harmonize at the global level, companies’ digital transformation becomes essential to remaining competitive.

Compliant solutions exist

GxpManager specializes in digitizing highly regulated sectors (pharma, biotech, medical devices, cosmetics, transportation, banking…). All our applications include access control, electronic signature, and audit trail functionalities natively.

With GxpManager, say goodbye to non-compliant spreadsheets and papers and digitize your business processes for simple compliance and increased productivity.

Source: *21st edition, Panorama France Healthtech 2023; France Biotech, 469 companies, January 2024