FDA Compliance / Automation

Validation of Automated Systems for FDA Compliance

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How to Get the FDA Compliance Audit by Keeping Records

Option A: Hard copies of data and documents as is the current practice Option B: Hybrid system of converting data into documents and then using DMS. DMS with the features like – Preparation, Approval, Control, Amendment, Withdrawal, Distribution and Archival.

Option C: Total IT based audit system, where software needed are – ERP/SAP/CAMMS with audit trail functionality, DMS and special software modules for process validation and analytical testing validation.


‘Option A’ needs one to keep log reports over a considerably long time period, and is cumbersome to adhere for validation. ‘Option B’ is an improvement, but, there is considerable time and effort required in preparation to archival of the records. ‘Option C’ is the latest and the most sophisticated solution.

The process validation of the system is documented based on the process parameters that are provided by the owner. However, templates provided by the software vendor aid in asset qualification and validation. The

21 CFR Part 11 Validation Plan includes compliance approach, organisation, system validation, risk evaluation, system gap analysis and remediation. The software package supports SOP’s (Standard Operating Procedure) which needs to be worked as per compliance approach by the client. The detailed module covers internal as well as external expertise levels validation. The system validation covers various system validation related to Process and Analytical know how and associated risks. In Gap Analysis, unadressed requirements and program/module/interface – integrity documentation is tested. Subsequently, the lvel of risk evaluated is mitigated based on the client’s requirements.

Forewarned is Forearmed – Preparing for FDA Audit

The Agency intends to exercise enforcement discretion with regard to specific part 11 requirements for generating copies of records and any corresponding requirement. You should provide an investigator with reasonable and useful access to records during an inspection. All records held by you are subject to inspection in accordance with predicate rules.

FDA recommends that you supply copies of electronic records by – producing copies of records held in common portable formats when records are maintained in these formats, and using established automated conversion or export methods, where available, to make copies in a more common format (examples of such formats include, but are not limited to, PDF, XML OR SGML).

In each case, we recommend that the copying process used produces copies that preserve the content and meaning of the record. If you have the ability to search, sort or trend part 11 records, copies given to the agency should provide the same capability if it is reasonable and technically feasible. You should allow inspection, review and copying of records in a human readable form, at your site using your hardware and following your hardware and following your established procedures and techniques for accessing records.