6 Ways to Take Control of Regulatory Compliance
It is mission critical for organizations to maintain a complete audit trail for engineering documents throughout its lifecycle. While organizations understand that complying with industry standards for asset information is important and required, the process can prove to be time-consuming and expensive.
For companies in the process industry, one of the key challenges is keeping track of constant changing regulations and shifts in technology and innovation. Organizations are under immense pressure from business stakeholders to extend the lifetime of their assets, while simultaneously confronting an aging infrastructure. The pressure to increase profitability has caused organizations to reuse and reconfigure assets to ensure they are getting the most out of their assets throughout its lifecycle.
Another challenge for organizations in asset-intensive industries is the desire to decrease unmanaged risk. Using the incorrect version of an engineering document could leave you vulnerable to increased corporate risk, failed audits and cost overruns that can extend into the millions of dollars, as well as significant risks to safety, schedules, and overall reputation.
There are 6 primary ways for organizations take control of regulatory compliance and ensure that they are meeting all of the requirements for managing their mission critical engineering documentation.
Regulated industries, such as Life Sciences, require structured documentation to ensure completeness. During implementation projects, Accruent facilitates our customers through the maze of validation documentation to ensure compliance. When changes are required during implementation projects and within our own software development process, we follow tested ‘configuration change management’ procedures. This ensures that all aspects of the proposed change have been thought through, documented, and agreed upon prior to making changes.
Accruent has a world-class team of implementation personnel, with the average tenure for the team over seven years with the company and over 10 years with the product, and every project manager PMP certified. Our engineering document and drawings management solution, Meridian, provides a central, secured and controlled environment for engineering information that is highly scalable and configurable.
Using a central vault, everyone is assured they are accessing the most up-to-date version of their engineering document and drawings. Within the central vault, there are areas that require higher security than others. For example, an approved, masters or as-built library is probably going to be the most used area. This is where maintenance and operations can find the asset information that they need while on-site.
Role based security allows Accruent Meridian to accommodate access rights that fluctuate and shift by project. Meridian leverages existing active directory groups to easily implement and administer role-based security and can be configured to allow single sign-on access.
One of the greatest challenges faced by companies that do not use a standardized central system to manage engineering content, is that the various locations, plants and facilities have often kept the same manner of tracking their mission critical engineering documents for decades, without regard to the numerous business changes that have occurred over the years. Flexible numbering, document naming and filing conventions help to accommodate multiple plants in one system, with acceptable differences between plants.
With a flexible engineering document management software system like Meridian, you can start to standardize the building blocks, such as look-up lists and mandatory fields. Automated revision control also ensures that project changes undergo revision updates and released documents show the latest approved versions, providing peace-of-mind.
Proof of Control
In any facility where field changes must be controlled, the modification of engineering documents is critical. Meridian delivers a controlled way to check documents out to certain projects, and control who has privileges to modify and approve. The configuration allows users to check out a document to multiple projects, as well as introducing checks and balances to ensure that modifications by users are not lost.
In addition to workflows on documents, Meridian allows for workflows on projects, and for the projects to be linked. During approvals, Meridian can also apply watermarks and electronic signatures and print stamps to ensure compliance with various electronic records regulations. This way, the user of these documents is always assured that they are using approved and current documentation. By using our engineering document management software, Meridian users can establish control of engineering data changes, safeguarding accurate review and approval steps for effective change control while ensuring safety and compliance.
Unplanned downtime due to audit failure or incompliance can negatively affect a company’s brand. By using Meridian, organizations can easily track who changed what, when they changed it and why. Meridian can track the reasons for the change, the decisions for, and the approvals of that change. Audit logs can be shown on a per-document basis, or, with sufficient privileges, the log for the entire vault. This ensures that organizations can be more confident during audits and decrease corporate risk as well as failed audits.
Integrations and Collaboration
It is imperative that organizations break down information silos between disparate departments to increase employee safety. It is important for an organization to be able to integrate different departments within a single platform for engineering information, in order to increase employee safety and productivity.
Data exchange with CAD applications includes active reference management and exchanging title block data. This can happen even if the user does not have CAD installed on their computer, as Meridian takes care of it. This data exchange can also be extended to include other in-house systems and large enterprise maintenance management systems like Maximo, SAP, etc. It can also extend beyond the enterprise. When exchanging data and documents with contractors, Meridian can help users ensure that the right data and documents are being sent and received.
Organizations in asset-intensive industries should be prepared to accurately describe what exactly that they do and then provide evidence to stakeholders that they did exactly what they said they would. For any given category or piece of equipment, a specific set of documentation must be available to meet the needs of stakeholders from departments including engineering, safety, maintenance, operations, reliability and project office. Accruent’s engineering document and drawings management system, Meridian, centralizes all of those documents within a single source of truth to readily provide access to relevant stakeholders and auditory bodies.