Streamline compliance in life sciences with CMMS

Governments strictly regulate the life sciences industry and to continue day-to-day operations, these organizations must remain compliant with regulations such as the U.S. Food and Drug Administration’s (FDA) Title 21 CFR Part 11 or the European Union’s (EU) EudraLex Vol. 4 Annex 11. This is where a best-of-breed computerized maintenance management system (CMMS) helps.

Numerous maintenance teams in the life sciences industry have deployed CMMS software such as eMaint to help easily adhere to the nuanced electronic record-keeping requirements spelled out in regulations. Following is a look at the requirements of Title 21 CFR Part 11, and then several key strategies to help organizations maintain and streamline regulatory compliance.

What is Title 21 CFR Part 11?

During the 1980s and 1990s, digital recordkeeping became increasingly common, allowing users to exchange information and audit records quickly and easily, leading to an increase in productivity.

However, despite clear benefits, electronic records sometimes failed to match the reliability and authenticity of paper-based records. For example, electronic records were subject to user entry error, changing records without a trail of tracked changes, and changes made by those without authority to authorize those changes, leading to poor record keeping. While the digital transformation helped maintenance teams take a step forward in productivity, historical data took a step back from paper record keeping. Title 21 CFR (Code of Federal Regulations) Part 11 addressed this problem by setting clear standards for how electronic records should be logged, validated, traced, and stored.

Part 11 was established to govern the manufacturing standards of life science organizations falling under the regulatory umbrella of the FDA, such as medical device manufacturers, pharmaceutical companies, laboratories, and more. Part 11 specifically establishes the criteria for ensuring electronic records are at least as reliable and accurate as paper records.

Failure to comply with Title 21 CFR Part 11 carries significant consequences, such as the company not being allowed to sell its products in the U.S. Non-compliance can also lead to an operational shutdown, costing valuable production time.

How to ensure compliance

A study of FDA records by Redica Systems showed 79% of warning letters issued by the FDA to the pharmaceutical industry from 2014 to 2018 – 483 letters – noted deficiencies in data integrity.

The FDA audits plants and other facilities for Title 21 CFR Part 11 compliance in using a comprehensive checklist marking internal systems for security, traceability, valid use, and reference purposes. With this in mind, the following strategies can help ensure life sciences or pharmaceutical companies improve efficiency while maintaining regulatory compliance.

Validate controls and procedures: Title 21 CFR Part 11 states internal systems must be accurate, reliable, and consistent. For security purposes, set up strict user roles and rights within your CMMS to restrict which personnel are allowed to approve records, update existing documentation, or edit core files or directories. Take immediate action if unauthorized access is detected, reporting the breach to an information technology (IT) manager, quality manager, or security unit. Life sciences CMMS software such as eMaint provides approved users with the ability to monitor system access in real time, while maintaining efficient workflows for quality approval.

Establish an audit trail: Per 21 CFR Part 11, organizations must produce complete files with time-stamped records of modifications – including creation, modification, and/or deletion – made throughout the lifetime of the record. The audit trail tracks a history of these changes on what the data was, what it changed to, the user that authorized the change, and the time and date stamp the change occurred. CMMS software makes auditing and tracking record changes as simple as possible, plus there’s no risk of lost documents as with paper records.

Follow electronic signature requirements: Title 21 CFR Part 11 specifies electronic signatures must include the approver’s credentials, date & time, and either the reviewed or approved-by indicator. The reason for the change may also be requested upon completing the change. The signature also must be attached to a specific record within the system. Electronic signature may depend on certain areas of the system, for example, requiring the electronic signature to update an asset status back into production. CMMSs provide an effortless method for documenting and tracking electronic signatures while ensuring those signatures are also compliant with regulations.

Keep complete and accurate copies of inspection results: 21 CFR Part 11 compliance requires organizations to produce and maintain accurate, complete copies of records and changes to those records. If a change is required to a specific standard operating procedure, it may require a change management process. A change management process within a CMMS will define the change, the reason for the change, and the multiple approvers of that change to enact it within the solution. This allows continuous improvement of policies and procedures while complying with regulatory standards. With eMaint, records and requests are accessible to approved users, whether they’re mobile or at a desk.

Although using the above strategies won’t guarantee organizations will be compliant with regulations such as Title 21 CFR Part 11, they go a long way in helping ensure companies are set up for success. The next step is choosing the right tool to enable life sciences companies to achieve specific compliance goals, while tracking and hitting key performance indicators (KPIs) – no matter what they are.

About the author: Tara Acree is an enterprise account executive for the life sciences and automotive industries at eMaint, a Fluke Reliability company. She specializes in SaaS-based solutions and hardware tools across enterprise platforms, focused on a best practices approach.

eMaint, a Fluke Reliability company
https://www.emaint.com