Organizations in the Life Science industries face a myriad of day-to-day documentation challenges and concerns as they attempt to juggle maintaining regulatory compliance, reducing costs, maximizing their speed to market and, ultimately, maintaining operational excellence.
This complex web of concerns calls for a sophisticated, multi-pronged solution.
With its powerful electronic document management capabilities, cloud-based technology and validation-as-a-service, Meridian Cloud for Life Sciences is just the solution.
Here’s what you need to know.
Key Challenges for Organizations in Life Science Industries
Life Sciences is one of the most regulated industries out there and between conducting research, improving organism life, making a profit and navigating red tape, professionals in the industry have a lot to juggle.
Specific day-to-day challenges include:
- Juggling maintaining quality and speed to market: In Life Sciences, products need to be introduced to the market quickly and in high volumes. This is no easy task – after all, quality can’t be compromised when people’s lives are at stake. That’s why getting this right requires that organizations address FDA’s GMP requirements and follow effective standard operating procedures (SOPs) to facilitate speed without compromising quality
- Maintaining regulatory compliance: Regulatory compliance with the FDA is difficult to maintain in Life Sciences, and it is becoming increasingly complex as factors like globalization, heightened transparency expectations, increased emphasis on innovation, and ever-evolving customer needs make regulations that much more complicated (and important). In this context, organizations in Life Sciences often struggle to assure regulators that their house is in order, shorten inspections, reduce costs of managing regulations and manage the costs of internal audits and safety inspections
- Pressure to reduce costs: There is constant pressure to reduce costs in Life Sciences, and this pressure is only getting worse as blockbuster products decline, generic options flood the market and new competition continues to drive down prices. In this context, maximizing cost effectiveness and efficiency is key — and it’s tough to get right
- Shortages of validation resources: With a validated system, change management needs to be held to a high degree of accuracy, which can be difficult for organizations that are using disparate systems or relying on an in-house IT bandwidth to take care of it
- Standardization of work processes: To perform more efficiently and reduce costs, Life Science executives expect their teams to leverage best practice and standardize their processes. This can be difficult if, for example, disparate systems make concurrent engineering impossible, or if unclear workflows leave people confused or working on outdated information
- Operational excellence: Overall, operational excellence must be achieved to beat out the competition, streamline compliance and lead the industry. This requires strong systems, skilled teams and flawless execution
Engineering Document Control Challenges
And those are just the high-level concerns. Looking more granularly at engineering departments, employees face challenges when trying to:
- Gain real-time, secure access to accurate and technical data
- Collaborate between internal and external stakeholders
- Eliminate silos and integrate relevant corporate systems
- Improve change management and project efficiency
- Improve design through feedback loops
These are complex concerns, and they require a comprehensive solution that includes the right software, tools and people.
Meridian Cloud for Life Sciences Can Help
With its powerful electronic document management capabilities, cloud-based technology and validation-as-a-service, Meridian Cloud for Life Science’s three-pronged solution can effectively address the Life Sciences industry’s most pressing concerns.
Meridian Cloud for Life Sciences: A Three-Pronged Solution
1. Meridian EDMS
At its most fundamental, Meridian Cloud for Life Sciences is powered by Meridian’s robust electronic document management system (EDMS). This allows Life Science organizations to centralize their relevant documents and engineering drawings, thereby replacing outdated, disparate or manual systems. It also provides a focal point for change management and a single, consistent source of truth that can streamline collaboration, facilitate compliance and simplify document version control.
General Meridian EDMS Features
Key features of the Meridian EDMS include:
- Reference management
- Revision control and compare
- CAD and Office application integrations
- Tag-Document association
- Concurrent engineering capabilities
- Redlining/commenting and feedback tool
- Mobile access
- Collaboration portal
- Analytics
Features that Facilitate Title 21 CFR Part 11 Compliance
These features accompany additional functionality specifically designed to support compliance with 21 CFR Part 11, including:
Controlled Workflow
When a user wants to make a change to a controlled document or submit it for review in Meridian Cloud, they initiate a controlled workflow to make that change. This forces documents to move through a defined workflow that requires users to pass through pre-defined review and approval steps. This helps maintain compliance and ensure that all boxes are checked.
Electronic Signatures
Electronic signatures are required when a GMP document is put into a workflow. Each person that must provide their electronic signature will receive an email letting them know that there is a document ready for their review. As each user reviews or approves the document, their electronic signature is manifested on the PDF rendition of the document in the order they signed. This not only helps ensure that the right people see the document but also simplifies document management and streamlines the audit trail.
Electronic Print Stamp
Every time you view, modify or print a GMP document in Meridian Cloud for Life Sciences, a print stamp and watermark will be automatically generated by the system on each PDF rendering of the document to provide key timing information. This can help maintain consistency of work across time zones and help employees understand, at a glance, which document is the latest and most up-to-date version.
Watermark
Along with the print stamp, users will also see a watermark across each document showing that document’s status. For both Office and CAD documents, a handy compare tool easily highlights what changes have been made between versions. In addition, when a new revision is created, the prior revision is automatically watermarked as “superseded” to ensure that only the current version is referenced.
Audit Trail
These features provide a clear and accurate audit trail, which makes the entire auditing process easy and intuitive.
Together, this suite of features provides transformative functionality that allows for effective engineering and compliance for Life Science engineering department. It also allows Life Science organizations to make informed decisions and:
- Seamlessly connect your engineering and maintenance department stakeholders
- Provide global and immediate access to business-critical documents
- Ensure compliance to Change Management standards
- Enhance efficiency by providing integrations with EAM, ERP, ECM, CAD systems, etc
- Reduce risk and cost in data handover process between external contractors and internal stakeholders
2. Cloud and SaaS
Many organizations in Life Sciences often pause at the thought of digital transformation: it’s difficult to deploy a solution that will truly improve flexibility, maximize resources and reduce costs. What’s more, many solutions on the market raise their own security concerns.
The SaaS component of Meridian Cloud for Life Science provides impactful gains without the drawbacks by shifting the majority of the EDMS and compliance burden to Accruent.
Looking at the basics of the SaaS deployment, it includes:
- Hardware, software, infrastructure, etc.
- Environment and application management
- Automatic software updates and enhancements
- Hosted in Microsoft Azure datacenters (initially in US and the Netherlands)
- Single sign-on authentication with Office365
- SOC 1 Type II and SOC 2 Type II certification
- ISO 27001 certified data
- 24/7 ongoing training and support
Additionally, Accruent manages most aspects of the system, including:
- Software
- Technical support
- Software upgrades
- Server hardware
- OS software
- DB software
- Hosting/data center
- System monitoring
- IT Admin support
- Back-ups
- Security audits
- Upgrade labor
This helps simplify compliance, increase uptime, reduce IT burden and decrease the IT burden on your team.
3. Validation-as-a-Service
Finally, the validation-as-a-service component simplifies compliance and ongoing system validation.
A cloud-based EDMS system that offers validation-as-a-service takes the majority of the validation process – and broader compliance concerns – off your team’s plate. This can save time, money and efficiency in the long run.
Specific features of Meridian Cloud for Life Science’s validation-as-a-service include:
- Pre-validated Meridian implementation
- Templated validation documentation
- Customer-specific validation documentation modifications
- Data migration (test and production)
- User acceptance testing
- Deployment, with the execution of the OQ and data migration protocol
Additionally, Accruent will be there every step of the way from system design through deployment.
Once your system is deployed, Accruent Managed Services (AMS) will provide your team with ongoing support in the form of:
- Re-validation of the core solution for each Quarterly Release
- Templates updated, if necessary
- Re-testing of core solution
- Risk assessment of changes relative to your configuration (assigned a risk level of 1, 2 or 3)
- Re-validation on level 3 items against your configuration
Final Thoughts
Meridian Cloud for Life Science’s three-pronged, pre-validated solution provides the functionality needed to improve engineering efficiency, streamline collaboration, maximize IT efficiency and facilitate ongoing compliance.
Ready to give it a try? Please reach out to start a conversation here.
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