21 CFR Part 11 relates to all records covered by FDA regulations that are in electronic form and establishes standards for managing electronic records and electronic signatures. The primary goal of putting this law into place was to avoid fraud while supporting and encouraging the potential use of electronic technologies to cut costs associated with paper sources.
21 CFR Part 11
In the FDA-regulated industry, 21 CFR Part 11 governs the use of electronic records and electronic signatures that are needed by predicate regulations governing manufacturing operations. It largely focuses on making sure that data in the form of electronic records and signatures is valid, trustworthy, and intact. The agency implemented the regulation in an effort to establish baseline compliance standards for electronic systems and reduce the likelihood of data theft.
21 CFR Part 11’s goals:
- System validation for accuracy and dependability
- improving the capacity to produce accurate copies
- Records management and system documentation identification
- avoiding techniques for record-falsification
- accurate and speedy record retrieval
- limiting authorised users’ access to the system
Implications of 21 CFR Part 11
All aspects of medical product research, clinical study, maintenance, production, and distribution by businesses that opt to employ electronic records or signatures are governed by 21 CFR Part 11. Even if records are not required to be submitted to the FDA but must be kept in facilities, the requirement nonetheless applies to all electronic records that exist in such facilities.
The usage of electronic records and electronic signatures by businesses is not required by these regulations. To meet compliance requirements, the rules also give the flexibility to choose specialised security measures.
Companies subject to FDA regulation are required to have a thorough implementation strategy that supports their corporate objectives and should be aware that the rules apply to all used electronic systems.
Importance of 21 CFR Part 11 Compliance
Regulations under 21 CFR Part 11 have expanded the scope of FDA inspections, leaving numerous companies open to non-compliance.
The FDA has recently tightened its enforcement measures, and non-compliance can lead to FDA Form 483s, warning letters, an injunction in the form of a market recall or a ban on importation or commercial distribution, among other things. This is especially true in areas like system validation and record protection, which are frequently cited during audits.
Citations for non-compliance may end up costing a lot of money because the FDA may take direct and indirect legal action against the violator. Publicly distributed warning letters may lower a company’s stock value and ultimately decrease sales.
Three compliance areas ought to be the emphasis of businesses:
- computer system verification throughout the development life cycle. To continue to adhere to Part 11 regulations, testing should come next in the firm’s existing operational context.
- Operations should be based on documented standard operating procedures,
- To meet criteria, system software features for the product should be used.
Companies have been informed by the Agency that:
They must completely adhere to 21 CFR Part 11 and all relevant predicate rules.
Revenue earned while breaking the law will be deemed illegal and subject to confiscation.
Additionally, non-compliance is punishable by harsh fines.
Various factors, including the importance of the data and the types of systems used to handle it, will be taken into account during audits to grade the compliance level.
It adopts a practical approach to issues and recognises that it will take time for existing systems to fully comply with 21 CFR Part 11
When enforcing compliance with technical controls like validation, audit trails, record retention, and so on, it will adopt a “risk-based” approach.