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Electronic Signature / Electronic Records

It seems as though every consulting & training company as well as the quality and regulatory professional organizations have been conducting training programs on how to comply with Part 11 since the release of the Final Guidance last August.  Part 11 is nothing new for pharmaceutical manufacturers.  They were the main reason why Part 11 was issued in 1997.   However, for most medical device companies either already using some electronic data system, from those relying on a MRP (material requirements planning) program such as MANMAN or MAS90/200 to capture purchasing, batch/traveller/DHR, and or shipping information, to home-brewed databases for QSR required complaint handling,  internal audit, or CAPA using an MS-Access/SQL database, according to FDA regulation, your time has come.

For several years, the Agency issued draft guidance and associated interpretive policy statesments which implied that ANY software which was used in support of compliance with another regulation would be subject to Part 11 requirements.  For several regulated companies, the FDA issued warning letters requiring correction of violative electronic systems.  Several electronic archiving systems and electronic document management systems enjoyed significant sales growth during this time as the warned manufacturers scrambled to put in place systems claiming to be "Part 11 compliant."

Last year, the FDA with little advance warning, rescinded the many guidances and declared that several of the most difficult requirements of Part 11, including the generation of unalterable audit trails was being placed on a discretionary exemption for legacy systems (prior to the issuance of the regulation) and where the regulated company relied and maintained a paper record which could be relied upon for compliance with another regulation.

The CRO Group has provided two strategic services with regard to Part 11:  Gap Analysis and Remediation.

Now, more than ever, based on the recent guidance, regulated companies who have electronic systems need to know if those systems are within the scope or exempt, and most importantly, if there are modest means for achieving the discretionary exemption from some or all the requirements of the regulation.  This is where our Gap Analysis service comes in.

In usually a few days, our Part 11 Consultant can go through all your electronic systems and determine regulation applicability and if applicable and in non-compliance, a series of remediation choices.

The CRO Group remediation services start with the preparation of a detailed project plan with work breakdown structure.  Remediation includes the process of improving and or replacing electronic systems from design and development to manufacturing and inspection, to everyday software products used throughout the industry to collect and trend FDA required data on complaints, product defects, corrective and preventive actions, as well as lot traceability, calibration and maintenance, and MRP.

Further, the Agency has said that it is moving towards nothing but electronic submissions over the next few years..  In fact, ODE claims that they are ready today for your electronically submitted 510(k) or PMA.  For more information on electronic submissions, click here.

To obtain a quotation for these services, click here.

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