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Indian pharma sees new Ultimate Guide to CFR Part 11 as a lucid document to adhere stringent regulations of the global regulatory agency US FDA. It mandates the use of digital technology and the need to maintain electronic records for the purpose of convenience, easy accessibility and transparency.
The regulatory authority considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
The purpose of CFR Part 11 is to ensure that electronic records and electronic signatures can be trusted as much as paper records and ink signatures. All electronic records that are used for regulated purposes are subject to Part 11.
For records required to be maintained but not submitted to the agency, companies can use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures.
An organizations using electronic records must document the procedures it follows and the controls it has in place for ensuring that their electronic records have the authenticity integrity, confidentiality, irrefutability which means in no way to deny that a record is genuine.
Further the documented procedures and controls needs to also address the validation as to how the data in a computer system can be trusted. The companies need to be systematic in rendering records to be provided in a language/format that humans not just computers can understand.
When it comes to document storage & record retention, the organization must put in place systems to protect the documentation and keeps it readily available for as long as it’s required to be stored. There is also considerable importance given to system access. Here the organization should ensure that only the right people have access to each computer system.
In the area of audit trails, the guidance mandates on how an organization ensures that a complete history of an electronic record is automatically captured by a computer system, retained in the system for the right amount of time, and viewable by humans.
According to Kaushik Desai, pharma consultant, the Ultimate Guide document to CFR Par 11, is very easy to understand the complexity of US FDA regulations. This we see would be most useful for all entry level regulatory professionals although detail knowledge is required which comes with experience. This also could be good for the pharmacy students before entering industry.
Pointing out that when India is the largest provider of generic drugs to US, and having largest number of US FDA approved facilities of 615 plants, Desai said that the understanding of this regulations is most important. The initiative undertaken by Perficient, the digital transformation consulting firm needs to be complimented. Likewise, experts shall make efforts in direction of providing all regulations including Indian of making such documents for the benefit of industry at large.
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