The pharmaceutical industry is a strategic sector that plays an essential role in a country’s economic and social growth. What’s more: according to IFPMA’s Facts and Figures 2024 report, the industry invested 30% of its revenues in R&D last year, amounting to some 270 billion euros. This effort not only reflects its impact on public health, but also its ability to drive scientific and technological progress.
However, the sector is made up of different phases that, because they have to be approved by several people, slow down what is really important: the well-being of citizens’ health. In this context, digitization in general and electronic signature in particular, are crowned as the best partners to face the difficulties of the sector, transforming document management and optimizing processes, ensuring regulatory compliance of laboratories and organizations.
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How does electronic signatures help in the pharmaceutical sector?
Did you know that, thanks to new digital advances, virtually any document can be signed electronically? If we put the focus on the pharmaceutical industry, we find that electronic signatures can be applied in documents such as:
Quality and Good Practice Documentation (GxP)
- audit reports and standard operating procedures;
- quality control records, instrument calibration and process, equipment and analytical method validation protocols/reports;
- change requests and process/product change impact assessments.
Intellectual Property and Patent Documentation
- patent registration, applications and renewals;
- development documents, records of creation of innovative formulas and processes;
Research and Development (R&D) related documentation
- clinical study documents such as informed consents, safety reports and clinical study protocols;
- research records.
Regulatory and Compliance Documentation
- registration with health authorities;
- statements of compliance with established regulatory standards;
- regulatory contracts, confidentiality agreements or pharmacovigilance agreements;
Manufacturing and Production related documentation
- batch production records
And, of course, all the documentation coming from any other department in the company: financial, legal, people management, logistics and distribution.
What regulations govern electronic signatures in the pharmaceutical industry?
However, can these documents be developed at ‘free will’? In other words, can each laboratory establish the bases it wishes? We regret to say no. The list we have just mentioned must be adapted to the specific regulations on the subject in each country, whether it is the 21 CFR Part in the United States, the regulations of the Spanish Agency of Medicines and Health Products in Spain or any other of the same category.
And if you do not know what we are talking about, we have prepared a practical guide with the main regulations governing electronic signatures in the pharmaceutical industry at international and European level. These are:
eIDAS Regulation
At European level, the reference regulation on electronic signature is the eIDAS Regulation. If you read Viafirma’s blog regularly, you will know that this is a topic that we are very aware of when we elaborate our publications.
This regulation establishes a uniform framework for the use of trust services and electronic signatures in the member states of the European Union, outlining the requirements that must be met in order to be equivalent to handwritten signatures. Applied to the pharmaceutical industry, it allows documents to be transferred securely across borders within the EU, facilitating international cooperation and regulatory compliance at the European level.
ESIGN
Beyond European borders and, in a broad aspect, when talking about electronic signatures in the United States, we find different regulations that regulate them. Mainly, the ones in charge of doing so are UETA and ESIGN, the latter being especially relevant:
- ESIGN (Electronic Signatures in Global and National Commerce Act). Since 2000, it has regulated the use of electronic signatures in commercial and legal transactions, recognizing them as legally valid. In the pharmaceutical sector, it is useful when signing contracts and agreements at international level.
Regulation 21 CFR Part 11
If we talk specifically about the digital solution that concerns us, we cannot leave aside the 21 CFR Part 11 regulation. Introduced by the Food and Drug Administration (FDA), it is essential for any pharmaceutical, cosmetic, chemical or food company operating in the United States, or in any of its territories.
Among other aspects, it ensures the legal equivalence of electronic signatures with paper records and handwritten signatures. To this end, signatures must meet a series of requirements:
- They must be reliable
- authentic
- and equivalent in all aspects to paper signatures.
To this end, security measures such as access controls, audit trails and validation of electronic systems must be implemented.
In addition to those mentioned above, each laboratory has the responsibility and duty to know the legal framework of electronic signatures according to the country in which it is located, and to strictly follow the relevant legislation on the subject.
Comply with pharmaceutical regulations and increase document security with Viafirma
In a context in which IFPMA’s Facts and Figures 2024 report points out future growth, companies and laboratories must have the best tools to help them stay competent, while streamlining processes and strengthening their security through electronic signatures.
Viafirma’s digital solutions meet high security standards, preventing unauthorized access and protecting data confidentiality, whether it is personal information of patients, pharmaceutical formulas or others. Thus, it ensures the integrity of the document and the privacy of the documentation.
Our 100% proprietary technology, developed by a professional team with 25 years of experience in the industry, ensures a good user experience and complies with specific regulations. With us, your drug approvals will not suffer delays, you will improve quality control security and you will be able to manage any other documentation you need. Don’t compromise anymore the security of your drug information; go ahead and manage the change with Viafirma.