Are you prepared when the FDA shows up at your door? Are your Standard Operating Procedures (SOPs) up to date? Is your product documentation current? More importantly, what is the status of your electronic knowledge and record-keeping processes?
Knowledge is often captured in manuals, instructions or regulations, but knowledge is also held in people’s heads. For the proper management of a record-keeping framework, it is crucial that the necessary knowledge to carry out tasks and processes is explicitly identified, documented, and used.
Electronic document and record management systems allow companies to manage documents and records throughout the document life-cycle, from creation to destruction. For the most part, documents are considered a work-in-progress until they have undergone a review, approval, signoff, and publication. At this point, they become a formal record.
Once a document achieves the status of a record, the company may apply best-practices or, in the case of medical device manufacturers, follow FDA 21 CFR Part 11 regulations as to how the record life-cycle will be monitored and managed. This typically involves retention and protection from change until events occur which relate to the record and which trigger the final disposition schedule to apply to the record. Typically, the record undergoes destruction at a set time after these events.
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7 Tips for Ensuring your Electronic Records Comply with FDA 21 CFR Part 11
When considering an automated electronic system for managing documents and business processes for your company, the following tips will help ensure that the system implemented is configured to comply with FDA 21 CFR Part 11 regulations:
- Electronic system must be able to delineate user permissions. All electronic records in the system must be able to be verified as authentic and the system must be able to generate an audit trail for all captured documents.
- Potential for a signer to reject an approval must be minimized. The system must require users to enter two passwords to approve any type of document collaboration: one for login; the second for approval.
- Electronic system must have a track record of reliable performance. A reliable performance record reduces the time and money a company spends on its overall validation efforts.
- Electronic system must have an automated training component that can provide automatic triggers when an essential quality document is revised to ensure sustained 21 CFR Part 11 compliance. System must also be able to automate the follow-ups and escalations of past-due training tasks as well as create audit trails for all training data. Depending on the company's internal corporate policies and risk evaluations, validation can be as simple or as thorough as the electronic system allows.
- All approved users of the electronic system must be sufficiently trained to perform their assignments. Proper training serves to increase efficiency, improve performance, and minimize the potential for non-compliance.
- Document controls must provide revision controls, change controls, and time-based system modifications. The document controls serve to determine what is needed to formulate an individualized 21 CFR Part 11 compliance checklist, which helps to evaluate the company’s internal business processes and corporate protocols.
- Electronic system must include individual fields for all required and supplementary information. Signed electronic records must include the following data: name, date and time of signing, and meaning of the signature. Electronic (and handwritten) signatures must be able to be linked to their corresponding electronic records and the electronic system must be able to link every signature with its specified record.
For additional regulations on record keeping, see FDA 21 CFR 280, Subpart M--Records.
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Does your company currently use an electronic computer system to store and monitor its records? Have you failed to pass an FDA audit due to poor record keeping? Please share your experiences in the comments below.