Automating Document Control Processes To Comply With FDA And ISO Requirements

By Brian Curran

How Medical Device Manufacturers Simplify Compliance by Automating Document Control

As a regulated product manufacturer, you have likely heard that often recited phrase “if it isn’t documented, it didn’t happen.” This motto, shared among life sciences companies, means an efficient document control system is at the core of quality management. Documents and records are evidence that your company follows the good manufacturing and document management practices required for compliance.

Standard operating procedures (SOPs), specifications, calibration instructions, procedures, packaging and storage instructions, test plans, and validation process reports are just a few of the documents you create and use during your medical device’s development life cycle. When your device is on the market, you add in design history files, change orders, complaints, and corrective action/preventive action (CAPA) reports.

Careful handling of the large amounts of documentation required for regulated products is critical for achieving compliance. Furthermore, document control guidelines enforced by the U.S. Food and Drug Administration (FDA) and the standards set by the International Organization for Standardization (ISO) continue to evolve. This means your document control system should be agile and scalable to keep up with the changing regulatory landscape.

This industry brief details the FDA guidelines and ISO standards that apply to document control, and it illustrates how digitizing document control processes is essential for ensuring ongoing compliance and future relevance.