At its most fundamental level, GAMP guidance on validation of computerized systems has long required that automated and computerized systems meet signature-level burden of proof. Whatever processes and workflows a particular system automates, the manner in which it achieves milestones, collects approvals or generally advances an initiative must mirror the reliability and accountability of an ink-to-paper signature.
But GAMP does not certify or verify technology providers. Anyone told that an automated or computerized system of any type is GAMP-certified while shopping for new technology should turn away fast. While systems can be certified by other standards bodies, no existing certification exists to acknowledge adequate validation and operational maintenance capabilities.
Peter Falcon, associate director – global quality assurance, IT quality, compliance and projects at Ferring Pharmaceuticals, has identified the most critical things to request from a potential technology partner in a validated environment, and the types of vendor qualities that can ensure preparedness when facing a regulatory audit.
It starts with a need
At its most basic level, Falcon claims shopping for artwork management resembles any high consideration purchase. Consider car shopping, for example. Many typically begin by defining the need and outlining the required specifications; they may care most about safety ratings, a four-door body style, gas mileage or other options.
The same is true when shopping for artwork management software. Depending on the treatment or product being packaged and its destination country, regulatory authorities and regulations vary, but any selected system must comply with the local requirements and regulations. This consideration should sit atop any shopper’s list of core requirements along with their most important features and functionality and help to inform the creation of a design specification, because pharmaceutical manufacturers should always expect and be prepared for regulatory audits.
Defining core requirements
Based on the defined need at hand, pharmaceutical manufacturers searching for a new automation technology should define their core requirements. Falcon’s advice for getting these core requirements right includes:
- Strive for simplicity when defining core requirements. Staying focused on the end-to-end business process being automated can help; that process must run properly in any computerized system and must do so in a compliant manner. In all instances, simple and controlled methods for transferring information are critical.
- Establish that the technology can accommodate a wide array of markets, including regulations specific to the category of treatment or product and all of the geographic markets in which the treatment or product is packaged, prescribed, sold and consumed. This can balloon to include a substantial number of regulatory authorities, regulations and stakeholders that must weigh in at various phases of the package design process.
- Ensure core requirements will secure a solution that delivers impressive return on investment and functionality, while actually automating or computerizing the manual, often paperwork-heavy processes they will replace.
- Confirm the solution will manage and retain historical records and associated evidence to demonstrate that all the right people have been involved during reviews, adjustments and approvals to ensure preparedness for the inevitable internal or external audit.
To learn more about Falcon’s recommendations on defining core requirements for artwork management technology in a validated environment, as well as gain insight into his own vendor selection process, download our NEW e-book: Validation and Operational Maintenance in Package Design Technology.
