Do I really need to know about electronic signatures in pharma industry??? ~ Indian Pharma

Hello readers here I would like to discuss about key points about 21CFR Part11 and key words associated with it.

Do I really know about this?

The answer is ''YES'', in pharmaceutical industry computers are unavoidable at the present scenario. Whenever you use computers to generate data , you need to follow this regulations.

Product development has become an increasingly critical factor in highly-regulated life sciences industries. The pharmaceutical, medical device, and biotechnology industries all rely heavily on validated software and product development systems.

While this may result in significant cost savings by streamlining complex operations, it can also subject developers to the provisions of ruling 21 CFR Part 11 from the Food and Drug Administration (FDA). FDA ruling 21 CFR Part 11 specifies how electronic records and electronic signatures can be used as a substitute for paper records

and handwritten signatures.

Background:

In March of 1997, FDA issued final part 11 regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper.

Effective:

After part 11 has became effective in August 1997.

Electronic data handling:

Electronic data handling offers noteworthy benefits in the manufacturing area and also for the huge amount of data generated in analytical laboratories. The use of fully electronic data acquisition, evaluation, management and archiving promises major improvements in the workflow.

This is relevant to USA then why we need to consider it?

The new rule has high visibility and is the subject of discussion not only in the United States but also in many other countries. There are two reasons:

Many pharmaceutical companies located outside the US export drugs to the US market, and as such they have to follow US regulations. The FDA can inspect these companies according to US regulations. In case of non-compliance, the company is not allowed to export pertinent drugs to the United States, which can have a tremendous business impact.
Other countries have similar issues with electronic submissions and may use the US rule as a guideline for their local regulation. For example, in Japan a regulation on electronic signatures and records was released in April 2005.

Why pharmaceutical companies would like to implement CFR21 part11:

Currently the use of electronic records as well as their submission is voluntary. Despite this voluntary character, pharmaceutical companies are already trying to implement the rule as quickly as possible because of three primary reasons:

In many situations using computers cannot be avoided, for example in analytical laboratories for automated data acquisition and evaluation. In this case the laboratories “must” comply with Part 11.

There may come a time when the FDA will no longer accept paper records and; Electronic records have some significant advantages vs. paper records: tangibly lower space requirements and easier retrieval are just two of those advantages.

The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). The rule has an impact on all FDA regulated industries that use computers for regulated activities.

Terms you need to know:

A clear understanding of the terminology is of utmost importance for a common understanding of the rule and its implementation. Therefore we will dedicate this chapter to terminology. All quotations come from 21 CFR Part 11 (1).

Electronic records:

Electronic records are "any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system".

Closed system:

A closed system is defined as an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.

Open system:

An open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.

Practically all systems in analytical laboratories are closed systems. With an appropriate security system in place, the laboratory has full control on who will access the system. An open system in a laboratory would be one where the data is stored on a server that is under the control of a 3rd party. Other examples for open systems are websites where everyone has access.

Electronic Signature:

An electronic signature is "a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature".

Electronic signatures are the electronic equivalent to handwritten signatures on paper. They may be based on biometric identification methods like fingerprint scanners or facial and voice recognition, but a simple combination of a user I.D. and password is also sufficient. Within a company, the user I.D. must be unique to a specific person. Electronic signatures are sufficient for closed systems.

Digital signature:

A digital signature is "an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified".

Digital signatures are required for open systems and as such need higher security levels. Therefore, in addition to electronic signatures, cryptographic methods have to be applied for authentication of the user and integrity of the record.

Biomerics:

Biometrics is "a method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable".

Examples of biometrics include facial recognition, voice recognition and fingerprint scanners. Most of them need specific hardware and software. The biggest problem with such devices is validating that they work reliably for the specified user but not for anyone else.

Hybrid systems:

Hybrid systems are a combination of electronic records and paper records. They are common systems in analytical laboratories today. Raw data are recorded electronically to reconstruct the analysis but the final results are printed and signed on paper. The FDA does not prohibit hybrid systems but has expressed some concerns about their acceptability.

Meta data:

Meta data is important for reconstructing a final report from raw data. In chromatography it includes integration parameters and calibration tables.

Predicate rule:

Predicate rule as referred in 21 CFR Part 11 are the 21 CFR Food and Drugs regulations (besides 21 CFR Part 11). They are basically promulgated under the authority of the Food, Drug and Cosmetic Act or under the authority of the Public Health Service Act.

In further posts, I will post more relevant information related to this topic. Meanwhile if you have any information about pharmaceuticals, please send to my email. We can share to rest of the people, helping hands are always welcome.

With regards,

e-mail: menneni.santhu@gmail.com