A quality systems view of 21 CFR Part 11

For some time, I've been critical of enterprise system vendors who claim their systems are "Part 11 compliant." (Part 11 refers to 21 CFR Part 11, the FDA's regulation regarding use of electronic records and electronic signatures.) My complaint, which reflects the FDA's viewpoint, is that software vendors, with very few exceptions, are not regulated by FDA. Therefore, their software products cannot be said to be "compliant." Part 11 does not regulate the vendors of commercial software--it regulates the users. At most, the vendors can "support compliance" by the users.

Part of the problem lies with software buyers who too often are looking for a silver bullet for Part 11. In my experience, companies pay too much attention to vendor claims of "Part 11 compliance" and not enough attention to whether their own IT departments and users are compliant in the maintenance and use of those vendors' systems.

Although Part 11 does require certain technical features of software, such as system-generated time-stamped audit trails, Part 11 mostly deals with the administrative and procedural controls that companies must establish in their use of systems. A computer system can have all of necessary Part 11 technical features, but if a company does not establish adequate administrative and procedural controls (e.g. limiting access to authorized individuals, rotating passwords, controlling system changes), that company will not be compliant with Part 11. I don't mean to imply that companies should ignore Part 11 technical controls. I would just like to see a little more balance.

So how can companies ensure that they are compliant with Part 11? By treating Part 11--and information systems in general--as an element of the firm's quality system. Simply,

1. Say what you do. Companies should review all information systems-related standard operating procedures (SOPs) to ensure that all of the administrative and procedural controls mandated by Part 11 are included. For example, is there an SOP that defines information security policies, and does it include rules for assigning and rotating passwords? Does the new employee procedure include a step to have the employee sign an agreement stating that his or her electronic signature is legally equivalent to a handwritten signature? There are dozens of points such as these that should be enacted in SOPs. The easiest way to do this is to develop a checklist based on the administrative and procedural controls of Part 11 and trace each item to SOPs. Where an item is not reflected in SOPs, a gap exists and SOPs should be revised or developed to cover that item. The result of this effort is a set of information systems SOPs that include all administrative and procedural controls required by Part 11.
   
   This assessment of the firm's information systems SOPs should also address requirements for software validation, information security, and confidentiality, as appropriate.



2. Do what you say. Once SOPs are developed to reflect Part 11 requirements, you must ensure that these SOPs are being followed in practice. An audit should be conducted globally to ensure that the Part 11 organizational-level requirements (e.g. new hire procedure) are being followed. The audit should also be performed on a system-by-system basis to ensure that the system-level SOPs (e.g. records retention, password rotation) are being followed. Again, a checklist can be developed directly from Part 11 to reflect these requirements. The audit should be repeated annually or bi-annually to ensure that the organization remains compliant.

Companies need to realize that there is no silver bullet for Part 11 compliance. Taking a quality systems view of information systems will ensure that companies are not only compliant from a technical perspective, but that information systems are trustworthy and reliable.

Links to related posts
Oracle unveils new electronic signature functionality for FDA regulated manufacturers
FDA finalizes guidance for 21 CFR Part 11
FDA drops the other shoe on Part 11
FDA signals change in approach to Part 11
Possible solution for FDA electronic record audit trail compliance
Business success is more than regulatory compliance
Buzzword alert: "Part 11 compliance"