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ROI CalculatorGood Documentation Practice (GDocP) ensures accurate, complete, consistent and reliable records. Enterprises must document as work occurs, not retrospectively. Documentation is created to be easily read, completed and linked/signed by the author, and corrections made as a result of an error must remain easily traceable back to the original record.
ALCOA+ principles - Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available - provide protection for integrity of data across Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
For medical device, pharmaceutical, and biotechnology companies, documentation provides the primary evidence to support that your procedures were followed, specifications were met, issues were investigated and resolved, and patients and users were protected.
Adherence to GDocP results in the safe development of inherently lethal products that these industries manufacture, and implementing control and best practice documentation allows traceability and accountability of quality products to be tracked and assured.
The integrity and documentation of data are essential themes contributing to inspection worldwide as reiterated by many regulators. The MHRA guidelines for GxP data integrity, WHO document for data integrity and PIC/S PI 041 all stress the importance of strong documentation practices and the ALCOA+ principle as foundations of trustworthy data.
Companies with a Document Management Systems (DMS) can prove compliance, at the highest of levels, when designing, developing, testing, manufacturing and treating drugs or medtech devices, and utilize it to facilitate audits by regulators on this basis. Without GDocP, audits become painful, submissions are delayed, and product release decisions become risky.
There are many DMS that are cloud-based and enable process-centered intranets and digital frameworks to allow compliant storage of all project documentation and scale with growth, all while making compliance with GDocP part of the company’s DNA from day one.
A modern eDMS/eQMS should help you to:
Create document workflows that match your organization’s processes, instead of being forced into a rigid template.
Control document creation, review, approval and distribution using strong version control.
Use Part 11-compliant e-signatures and an extensive audit trail for all critical records.
Manage training so you can demonstrate all personnel who have been trained on specific SOPs and the date they received training.
Share current documents with your suppliers, customers and auditors securely through an extranet.
Utilizing one of these from day one of your med tech product development journey can help to address a number of GxP requirements in the best possible and most sustainable way.
In addition, your choice of DMS must have all of the tools and functionality for compliance to the appropriate regulatory standards. That includes, among other things, full and rigorous version control, timestamps on records, detailed information regarding what has been changed on records, and integration of digital signature technology to allow for signatures and track approval.
Put simply, it must be a reliable, secure and auditable record of every aspect of the creation of your documents and how they are handled, while also helping you to comply with the principles of ALCOA+.
