A Compliance and Traceability Toolkit

A growing number of quality management and compliance packages can help you seize control of processes and documentation, and prepare for FDA audits.

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Information on compliance software providers and products may be found on Page 2 of this article.

As the FDA and other regulatory agencies around the world emphasize the importance of systematic approaches to quality, many drug manufacturers are still relying on a patchwork of disparate paper documents and software to handle compliance. This siloed approach may work fairly well, until there’s a change — a key expert retires or leaves the company, or the company is acquired.

Recent 483s, warning letters and consent decrees issued to drug manufacturers have all drawn attention to the fact that CAPA (corrective and preventive action) and other processes need to be improved. As the Aberdeen Group’s recent survey suggests ("Compliance and Traceability in Drug Manufacturing," Feb. 2007), automating and integrating process and documentation management can pay off in improved knowledge and control. Costs are high, but technology providers say that implementation costs are offset by dramatic reductions in vulnerability.

More drug companies are implementing the required software. Teva USA, for example, has installed MasterControl’s suite, Poland’s Polpharma and Roche Carolina are using Sparta Systems TrackWise, while Cardinal Health (Dublin, Ohio), West-ward Pharmaceutical Corp. (Eatontown, N.J.) and Leiner Health Products (Fort Mill, S.C.) are using Pilgrim Software’s platform.

Best Practices

We asked Tim Fischer, Leiner’s director of regulatory compliance, to share some of his team’s experiences in implementing the software. His advice, in a nutshell:

  • Spend the time needed to ensure that you know what you want and select a product that can deliver.


  • Remember that someone has to dig in and learn the software to keep the implementation on track. Don’t be tempted to launch a whole module based patform at one time. Stay focused by using the plan, prioritize and execute one module at a time. Keep the server and software critical path going at the same time that the workflow implementation critical path is going.


  • Don’t be fooled by the idea that, once Performance Qualifications are completed, the job is over. In one sense, a new job has only begun, that being keeping a validated software package validated.

Leiner’s implementation team spent a considerable amount of time working through a User Requirements Document that called for several key aspects of cGMP compliance to be automated, among them electronic documents, CAPA training and audit management as well as complaint handling. Initially, says Fischer, 12 vendors were evaluated but three were invited for a live demo and discussion with a cross-functional team.

Another lesson: work on parallel tracks. “Initially, I thought that a three-person implementation team for each module would work well, in a ‘big bang’ approach to getting all modules up and running,” Fischer says. “However, I learned that it is best to develop a two-track implementation plan.”

On the first track, Fischer suggests that IT and validation qualify servers and software, including the running of OQ scripts. Then on the second track, in parallel, that the implementation team focus first on the module that will provide the biggest bang for the buck, such as the the document or audit modules, which have straightforward workflows.

Ongoing maintenance and change control are critical, Fischer says. Leiner established a change control council which met regularly each time a new patch or release was introduced. “This group must include functional administrators and the database administrator in charge of the software changes,” Fischer says. “The group has to stay on top of this key maintenance piece.”

A systematic approach and the right tools will help avoid an audit. Patricia Santos-Serrao, RAC, life sciences manager with Qumas, proposes the following best preventive practices in her blog (http://blog.qumas.com/Life-Sciences):

  • Communicate with the auditors;


  • Conduct mock, surprise audits;


  • Assign a compliance person to each functional area;


  • Audit your knowledge base and users — In the event of an audit, how quickly can you access relevant documentation on your policies and procedures? Ask yourself these questions, Santos-Serrao suggests:


  1. Do most users access the information they need on the first search?


  2. How much time do users spend reading the content that is delivered before they find what they need?


  3. How often and with what frequency does or will the average user access the knowledge base?


  4. Are there “power users” and “casual users” of the knowledge base? Power users can provide the best insights on how the data is organized and what tricks they use to get best results? Casual users can point to the areas that are most frustrating.


Information on compliance software providers

Below is a sampling of some of the tools now available that can help any pharmaceutical manufacturer develop a more systematic approach to compliance and quality.

Automate Pharmaceutical Quality Systems

The MasterControl integrated quality management suite is a configurable, off-the-shelf, and easy-to-use software solution that facilitates GxP or CGMP compliance from R&D through post-marketing. It integrates different quality processes and connects various departments involved in the compliance initiative. MasterControl automates, streamlines, and effectively manages document control, change control, training control, audits, corrective/preventive action (CAPA), customer complaints, and other forms-based quality and business processes under a single Web-based platform. For companies seeking compliance with the Sarbanes-Oxley Act, MasterControl offers a complete solution for managing SOX processes. It includes the following components:

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