Technology is an integral part of the production process. While we used to talk about ‘working on the computer,’ today, computerization is ubiquitous in our daily routines across various sectors. However, in regulated industries, there’s an additional layer: system validation.
It’s no surprise that industries highly regulated, such as pharmaceuticals, food, or cosmetics, require constant inspection of their computerized systems.
Nevertheless, due to a lack of awareness or investment in these requirements, some regulated companies still don’t have their validation areas structured, and their systems may not align with current standards. To shed light on this subject, we’ve prepared an article to address any doubts you may have.
What we will cover:
System validation: what is it?
As complex as it may seem, software validation deals with simple matters. To make everything clear, we need to go through one definition at a time.
1) What is a computerized system?
A computerized system is any system that uses information technology in its operation.
As we’ve said, nowadays production – in any industry – is highly organized by computerized systems. For example: issuing records, batches, customer service, etc.
A computerized system involves not only the software, but also all the hardware, networks, and all the documentation and functions that this system controls.
2) What are regulated industries?
The regulated industries are those that are part of the life sciences, such as pharmaceuticals products, food, sanitizers, cosmetics, etc.
They are regulated because they manufacture products for human consumption that need to undergo careful assessments to guarantee consumer safety. This evaluation goes through all sectors of the company, and computerized systems are part of this.
These regulatory requirements are known as good practices, or BPx, and are defined by regulatory agencies in Brazil and other countries, such as ANVISA, the FDA, among others.
Veterinary companies, which are also considered regulated (by agencies such as MAPA), although at the time of writing this article they do not yet have any legislation for validation, often also validate their systems as a matter of good practice, just like other regulated companies.
In addition, companies that are part of the production process in these industries, such as logistics operations, customer service, among others, also need to be validated and follow good practices, as do product distributors, who have specific standards for their segment.
3) What is system validation?
If we put the two parts together, we get that computerized/computerized systems validation – or software validation – is the process of ensuring that all of a company’s computerized systems in the regulated industry (with regulatory impact) comply with BPx.
This process is based on risk tests, which seek to identify points of failure in systems that could have an impact on product safety and consumer health, for example in the production of a medicine or food product.
Software validation provides documented evidence that computerized systems with an impact on GMP comply with the purpose for which they were designed and with current legislation and guidelines, guaranteeing the security, traceability and integrity of data, product quality and consumer safety.
But what needs to be validated?
Every system involved in processes related to good practices in regulated industries needs to be validated.
The Guide to the validation of computerized systems, published in 2020 by ANVISA, lists the types of systems that need to be validated. If your system answers “yes” to any of the following questions, it needs to be validated:
- Does the system store data that implies product traceability?
- The system manages:
- Automated operation of critical production equipment or individual laboratories (e.g. compressors, fluidized bed dryers, HPLC, dissolvers, etc.)?
- Automated operation of the generation of critical utilities (e.g. purified water, air conditioning, fresh air, water for injections, etc.)
- Registration of presentations, dosages, raw materials, packaging, potencies, batch sizes, production stages, master formulas, etc.?
- Production planning (e.g. production orders, batch numbers, raw materials, packaging, etc.)?
- The materials purchasing process (e.g. qualification of suppliers, control of orders from previously qualified suppliers, quantities, powers, specifications, etc.)?
- The receipt of materials (e.g. number of batches, sampling plan, physical condition, damage record, etc.)?
- The storage of materials (e.g. status, addressing, movements and transfers, collections, etc.)?
- The weighing center (e.g. weighing orders, power, fractionation, containers, scales, labels and seals, weighing results, operators, product batches, material batches, etc.)?
- Production control (e.g. manufacturing orders, in-process controls, records, operators, materials, batch numbers, equipment used, sequences of use and operation, alarms, samples, etc.)?
- Customer service (e.g. complaints, actions, adverse events, etc.)?
- Documentation (e.g. issue, distribution, revision, obsolete version control, training, etc.)?
- Quality systems (e.g. out-of-specification results, self-inspection, deviations, change control, records of raw material, packaging or product analysis results, periodic review, etc.)?
- Training program (e.g. scope, instructors, attendance lists, certificates, etc.)?
- Equipment (e.g. maintenance and execution plan, calibration plan and execution, qualification plan and execution, etc.)?
It is important to list all the systems involved in production and analyze them based on these questions.
The importance of validating computerized systems
It is important to understand that system validation is not just a whim of the industry. When it comes to consumer safety, you need to be very careful in all production processes.
We mentioned at the beginning of the article that not all companies have their systems validated, but there are several reasons to validate software.
1) Compliance with the law
Validation of systems in highly regulated industries is the law, according to the following RDCs (Resolutions of the Collegiate Board) and INs (Normative Instructions) bellow:
- RDC 654/2022 – which provides for Good Manufacturing Practices for Active Pharmaceutical Ingredients;
- RDC 658/2022 – which provides for the General Guidelines for Good Manufacturing Practices for Medicines;
- IN 134/2022 – which provides for Good Manufacturing Practices complementary to computerized systems used in the manufacture of medicines;
- IN 138/2022 – which provides for Good Manufacturing Practices complementary to qualification and validation activities.
These are ANVISA regulations, which are based on GAMP5 (Good Automated Manufacturing Practices), published by ISPE.
2) Product safety
System validation laws exist to protect consumers. Ensuring that the systems are validated and the processes are adequate is an essential safeguard so that the end customer can consume the product safely, without risk to their health.
3) Discovery and reduction of risks and failures in processes and systems
The validation of computerized systems is based on risks. Tests are carried out with the aim of finding flaws in the system, so they require a specialized multidisciplinary team to do so, sometimes with the presence of the system developers themselves.
By looking for flaws and risks, they may be found. This gives the company the chance to correct problems before they happen, guaranteeing consumer safety and preventing the company from spending resources on dealing with the problem after it has occurred. Software validation is a preventive measure.
4) Data security
Keeping secure records is important for any company, but even more so for those in regulated industries.
In addition, many companies don’t have internal security measures in place, which can lead to data being lost or information being tampered with. That’s why validation is so important.
The importance of specialized knowledge
Although system validation is simple in its definition, putting it into practice is a complex job, as it involves different processes and technologies, and requires a specialized, multidisciplinary team with a keen eye.
Organex operates in the data validation sector throughout the production system of regulated industries and other segments beyond industry. We offer solutions in:
- Structuring the systems validation area;
- Mapping and elaboration of user requirements;
- Validation of information systems;
- Validation of automation systems;
- Validation of electronic spreadsheets;
- Qualification of systems and services suppliers;
Qualification of the IT infrastructure; - Gap assessment of bpx software ;
- Audit;
- Drawing up functional and technical specifications;
- Training;
- Allocation of professionals.
Learn more about Organex’s work in systems validation. Just go to the website by clicking here.
