Life Sciences

Changes in customer preferences have encouraged the life sciences industry to move towards providing more high touch care

Changes in customer preferences have encouraged the life sciences industry to move towards providing more high touch care Life Sciences

The High Risk For Life Sciences

Changes in customer preferences have encouraged the life sciences industry to move towards providing more high touch care This requires more integration with external organizations and increased data collection.

The life sciences industry faces some unique challenges when it comes to data and digital technology. Cybersecurity threats and breaches in the life sciences industry can not only cause damage to financial health and reputation, but put the health, security, and safety of many people at high risk.

For example, if biotech data becomes compromised, it can put information that can lead to the development of dangerous products and bioweapons in the hands of attackers and cybercriminals. The life sciences industry also faces the risks of compromised clinical trial data, confidential information, and commercially sensitive information.

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Managed Security Solutions With Digital Forge

At Digital Forge, we understand that digitization is essential to innovation and growth in the life sciences sector and that protecting data and meeting compliance is more important than ever before.

Team of Expert Consultants

Our team of expert consultants and security intelligence professionals will work with you to continue evolving with the use of data and technology while maximizing IT infrastructure efficiency and minimizing risks.

Dedicated Team of Professionals

From building risk governance to identifying threats and maintaining security protocols and compliance, when you work with Digital Forge you have an entire security team on your side, so everything is taken care of.

Pharmaceutical

Life Sciences

The Biotech and Pharmaceutical market is becoming more globalized, and with that transition comes the challenges of adapting to new marketplaces.To stay relevant and competitive in this marketplace, collaboration, secure file sharing, and mobile device access are necessary

on a global level, bringing with it the need for risk management and compliance with a myriad of regulations. To manage these challenges, the organizations in the biotech and pharmaceutical industry need reliable, secure, and high-performance IT infrastructures.

What Digital Forge
Can Do for You?

The current life science environment has massive requirements for IT infrastructures that are secure, agile, stable, and cost-effective.

At Digital Forge, our expert team has years of experience in successful IT infrastructure support and management for the life sciences industries, so we ensure that you receive all the IT support you need, so that you can benefit from:

Stable and efficient IT infrastructure that meets your business requirements
Strategic IT action plan and future roadmap
High audit security
Meeting and maintaining compliance
Minimized deficiencies
Quicker product to market time

Data is critical to your biotech or pharmaceutical organization, and how you manage that data is vital. With Digital Forge, we handle your IT infrastructure and support as your partner, so you can always count on the best results. Contact us today, and prepare your organization for industry innovations.

FDA Compliance

FDA Life Sciences

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Compliance with the Federal Drug and Food Administration (FDA) is essential

All pharmaceutical organizations, as well as many organizations that work with pharmaceuticals in any way, including pharmaceutical marketing are required to comply with FDA regulations.These regulations ensure that pharmaceutical products are of high and safe quality and provide consumers with a level of trust in your organization’s products.

Unfortunately, today many pharmaceutical organizations struggle to meet FDA compliance as they strive to stay ahead of the competition, manage quality control, and focus on turning a profit. At Digital Forge, we’ve perfected our compliance services to ensure your organization meets and maintains compliance, improves quality processes, and gets products to market quickly.

Digital Forge’s

Comprehensive
Approach

When you partner with Digital Forge, you get an entire cybersecurity and compliance management team that works with you every step of the way.

That means our experts will be there from product idea generation to long after the product launch, to ensure that cybersecurity and compliance issues don’t hinder your efforts.

Some of what we offer with our compliance services for the pharmaceutical industry include:

Clinical trial management
NDA/ANDA/DMF submissions
Quality system strategies and implementation

Audits
Training
Validation
Support for FDA inspections
Assistance with FDA audits, warnings, corrective actions, product recalls, etc.

Failure to meet FDA compliance can lead to fines, penalties, regulatory actions, recalls, and more all leading to a poor reputation, loss in customers, and a decrease in revenue. To avoid these consequences, it’s essential to understand FDA compliance and implement effective compliance strategies and crisis response plans.

At Digital Forge, we offer all that and more. Contact us today, and see how we can take your pharmaceutical organization beyond compliance.

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Pharmaceutical

Compliance in the pharmaceutical industry goes beyond financials and regulations, incorporating life or death consequences. Digital Forge understands the critical nature and maintains compliance through US, UK and global regulations that can be integrated with your organization to assure the ability to do business wherever you desire.

Construction

Years before a product is ever manufactured the materials used are taken into consideration. Before your facility is ready for use, we want to work with you to align compliance to regulations applicable to your business. Our Digital Forge experts can help align data management and cybersecurity of information obtained during the construction phase that lead to smooth validation processes and FDA approval for operation.

Validation

During the validation process, data accuracy and maintenance are critical to smooth transition from construction to production. We help you assure compliance with GMP before manufacturing starts, aligning the product contact data collected during construction and integrating with the validation data collected during engineering studies and commissioning. It would be detrimental to the release of product, often times for years, if validation data is compromised. Don’t let this slow you down, a Digital Forge consultant can assist.

Validation

Operations

Regardless of what pharmaceutical product you manufacture, there are tremendous amounts of data collected and evaluated. Your data may include product contact, cleaning, environmental, formulation, visual inspection, testing and quality checks. That is all integrated with batch release testing and ingredient and product traceability. Without this data, your product will never make it to market.

Operations

Laboratory

Laboratory compliance comes into consideration before production during research & development as well as after production in post-production quality checks and batch testing. Every aspect of the laboratory, monitored through instrumentation, provide data to support research or product data.

Good Manufacturing Practice starts during construction data collection and continues through every element of the pharmaceutical lifecycle.

Good Manufacturing Practice starts during construction data collection and continues through every element of the pharmaceutical lifecycle Life Sciences.

FDA and Clinical Trials

As pharmaceutical data is developed it progresses to FDA approval, evolves through clinical trials and eventually makes it to market for public use.

If a breach were to occur or data lost, it compromises the integrity of the data. Compromised data means the product may need to be disposed of, or the process reproduced to confirm the data.

FDA approval for a facility to move to production (either for clinical trial or mass production) requires validation and commissioning of all equipment, testing and engineering study for each device, and the results of test runs.

To progress from Clinical trials to mass production, the data collected must be proven to be contemporaneous, accurate, original, attributable, and legible. We can not only help you maintain that data with security systems, but the appropriate way to collect the data to meet all compliance regulations.

If a breach were to occur or data lost, it compromises the integrity of the data. Compromised data means the product may need to be disposed of, or the process reproduced to confirm the data.

Life Sciences

Large and Smaller Pharmaceutical Companies

Large pharmaceutical companies need to stay up to date, and a Digital Forge consultant can be the critical step to staying ahead. Our consultants will assure any industry data for cybersecurity is brought into consideration, implementing the elements necessary for FDA approval, clinical trial compliance, and coordinate accordingly with HIPAA

Large pharmaceutical companies need to stay up to date, and a Digital Forge consultant can be the critical step to staying ahead. Life Sciences

Smaller pharmaceutical companies and laboratories may need ad-hoc assistance or part time compliance specialists to guide internal teams. Don’t look beyond Digital Forge, as we take the expertise and experiences with large companies and cater it to the perfect implementation for your smaller company.

Smaller pharmaceutical companies and laboratories may need ad-hoc assistance or part time compliance specialists to guide internal teams. Life Sciences

Digital Forge Is Here To HelpMaking Sure Your Batch Test Data Is Secure

Data integrity is critical to all life science production processes, from R&D through production. Digital Forge is here to help, making sure your batch test data is secure, and making sure your engineering studies and validation are complete. When it comes to Pharmaceuticals, we all need to do our part to assure medicine can make it out to those who need it most.

It’s more than our job, it’s our social and moral commitment to help you reach and maintain compliance.