A not so bitter pill
A not so bitter pill
Audited information management is an integral part of pharmaceutical manufacturing.
It doesn't take a huge amount of effort to imagine the scale of disaster that the bad document management at Ansett (as featured in the January/February issue) could have caused. Thankfully it never happened. One industry that knows it cannot risk any form of bad information management is pharmaceutical manufacturing. Forty years on, the pharmaceutical trade cannot forget the effect the thalidomide cases of the 1960s had on it.
Australia's Therapeutic Goods Association (TGA) borrows much of its regulations from the Food and Drug Administration (FDA) in the US. The US authority has very strict regulations on the processes for the production of pharmaceutical products and on the record keeping of the manufacturing process.
Two companies that manufacture pharmaceuticals in Australia are local company Herron Pharmaceuticals and global giant Pharmacia. The latter produces products in Perth which are shipped to the Australian and the global market, whilst Herron is moving towards a greater export market and has already begun successful exports to the Middle East. As a result of competing in the global market place, both have to adhere to the restrictions and practices of the Good Manufacturing Practices (GMP), a self-regulatory code of practice, developed by the FDA and adopted by just about every pharmaceutical regulatory body worldwide. To comply, both have adopted a SSA Global Technologies (SSA GT) enterprise resource planning (ERP) systems that provide record keeping processes.
REGULATORY BODIES
Regulatory bodies worldwide have their own sets of operational and documentation regulations. If a company wants to expand internationally, they must ensure they adhere to each country's regulations. The US market is the largest drug market, representing 51 per cent of the world market in 2002, and as a result many want to enter that market.
Consequently, the FDA is the leading regulatory body internationally when it comes to compliance.
Gary Clay, the IT Manager at Pharmacia Australia said, "The FDA is at the forefront and they've been working closely with other authorities in an attempt to harmonise and globalise these standards."
Regulatory bodies have been established to ensure community health and safety and ensure manufacturing practices are standardised. Any changes in the manufacturing process must be tested, proved, guaranteed and able to be reviewed. All of this needs to be documented either manually or electronically, which acts as a strong barrier to business process improvements commonly adopted by other industries.
The aim of the audit trail is to provide the company and regulatory bodies with total visibility to core data across the entire company, thus avoiding any Enron scenarios. Without the ability to provide the audit trail to the FDA, manufacturers cannot compete in the US.
Pharmaceutical companies retain comprehensive documentation of manufacture. This documentation includes batch and laboratory records, some of which are signed by the person responsible for an action, then countersigned by an "Approver." Records, as a legal requirement, have to be kept for possible recall for many years. Many of these records are maintained manually as hardcopy, but now these can also be maintained electronically.
ELECTRONIC AUDIT TRAIL
The FDA developed Article 21 CFR Part 11 in 1997. This article describes the technical and procedural requirements that must be met for a company to maintain records electronically and use electronic signatures instead of hand written ones. Other regulatory bodies are expected to follow the FDA guidelines.
"This is proof that you went through the process," said Mr Clay. He explained that the electronic records systems provide an audit trail that if an FDA auditor required they could produce. The audit trails time stamp records with the date and time of any actions a user within the company makes. It is a requirement of the FDA that any changes to an electronic record do not over write the original record - these records can be kept for up to 12 years after the life of the product.
Electronic signatures form an important part of this audit trail process. It is an FDA requirement that an electronic signature can be assigned to just one individual in the pharmaceutical company and if another person was to use that signature, they consider it record falsification. Each manufacturer has to certify to the FDA that each signature is intended to be a legally binding equivalent of a hand written signature.
"Each company needs to understand this [Article 21], interpret it and come up with an implementation," Mr Clay said; he explained that ultimately the regulations are there to ensure that the product that gets to the customer is the right one and the right strength, which is critically important for pharmaceuticals. "The implications for a global company are, if they find an issue in one plant, the FDA regard this as a given to all plants." Thus an error in a plant in Europe or the US could have implications for our ability to manufacture in Australia.
"e-Records functionality in the BPCS ensures that if you make changes to records in the ERP system then there is a record of that change," said Dan Kelly, the SSA GT pharmaceutical expert.
LiveAudit, as the electronic records part of the ERP system is a selective journaling application, which creates a master file. Every time a file or field is changed it sets off an audit trail. The audit trail consists of a series of images of the updates. Management can access these using a business intelligence (BI) application. The audit trail also traces electronic signatures and makes records of changes made by a signature bearer "If you are going to sign on paper, so then the equivalent in electronic is needed," said Mr Kelly.
"A process has to be measured and predictable. If you computerise it you have to guarantee that it will follow the process," said Mr Clay, adding, "It places a huge cost on us, but the end process is to ensure it is predictable." Any deviation could have dire consequences for the customer and the company. Like an airline, the pharmaceutical industry is dealing with the safety of people, not just profit and loss. "It's almost like a black box," Mr Clay said of how the audit trail records management keeps them on course. He describes the industry as being "conservative" compared to others, but this conservatism is what keeps the leaders in business. The collapse of auditor Arthur Andersen as a result of not being conservative show that wearing the little "c" is not always a bad thing.
The conservatism does not mean that the pharmaceutical industry is a technological dinosaur. Werner Kerstens, the IT manager for Herrons explained that the BPCS ERP system they use is completely integrated into their financial systems, supply chain management, manufacturing, online banking, payroll, dispensing, email, purchase order, process control and the automatic submission of customer statements. "For almost 10 years SSA GT BPCS has maintained its role as our main information repository."
LIVING WITH REGULATION
Since the business collapses of 2002, many industries, especially in the US and Australia, are going to have to face a regime change. Already the effects are showing as accounting houses sell off their professional services divisions to avoid accusations of being another Andersen. The effects of the WorldCom collapse are yet to be known; HIH continues to be pulled apart by a Royal Commission and BAT could still lose its case in the appeals.
The pharmaceutical industry is used to living under a strict regime of governance; whether it is from the FDA in the US, the European Agency for the Evaluation of Medical Products, State Pharmaceutical Administration of China, or our own Therapeutic Goods Association. Business practices and technology have evolved to accommodate the governance and SSA GT has concentrated on producing ERP and information management tools for highly specialised manufacturing sectors.
"People do what you inspect," Mr Kelly said. Perhaps if Andersen had known that the Securities and Exchange Commission would inspect Enron's accounts, innocent workers would still have pension funds. "In pharmaceuticals there is more of a drive to strive to an ideal than any other vertical. There is a cost to that, but because of the risks involved this is absorbed. In pharmaceuticals the government does the audit - there is no way of playing with the numbers."
As a result, electronic records and signature systems have safeguards built into them; unauthorised use of a password will trigger a report to the systems administrator. "That's where the conservatism of the industry comes from, as to make changes is a significant effort," Mr Clay of Pharmacia said.
"Pharmaceuticals is a pre-curser of what will happen in other industries, and their focus on business practices and best practices. The FDA effectively legislate good practices," Mr Kelly said.
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