Most organizations realize the “true cost” of any business investment is not the initial purchase price, but the Total Cost of Ownership (TCO). TCO measures initial costs plus ongoing costs including those that are not easily measurable, such as risk mitigation, personnel, utilities and maintaining and retiring the asset. Over the past decade, cloud-based Software-as-a-Service (SaaS) solutions have reduced TCO by 77% compared to on-premise counterparts. Until recently, the Life Science sector, were slow adopters of SaaS solutions due to concerns over security and regulatory compliance. Adoption is now increasing as cloud infrastructure players, such as Amazon Web Services (AWS), Google Cloud and Microsoft Azure, and SaaS providers now offer systems specially designed to meet the needs of FDA-regulated companies.

In parallel with the maturity of SaaS solutions, there is increased demand for software solutions to improve data aggregation, analysis and sharing in Life Science operations due to: { Substantially more data being generated with the rise in complex manufacturing processes { The industry’s extensive reliance on paper, spreadsheets and legacy, enterprise solutions { The FDA’s increasing regulatory scrutiny around data integrity and the drug owner’s ability to demonstrate process oversight Sharing data across global, disparate supply chains of Sponsors, and contract development and manufacturing organizations (CDMOs) – while ensuring the integrity of product, process and patient data – is necessary to meet regulatory requirements, accelerate product commercialization, protect process intellectual property, and maintain product quality. This paper outlines the TCO advantages of SaaS solutions and how purpose-built solutions meet the critical needs of the life science industry.

There are many factors to evaluate when calculating TCO of a software solution, and critical differences between on-premise and SaaS approaches. Additionally, each individual solution, including initial pricing and maintenance, can have a major impact to lifecycle costs.

License Costs

While this is the most obvious cost in a TCO calculation for a software offering, the costs of ancillary software required to run the application (e.g. operating system, VM software, database) must also be considered. For on-premise applications, these are typically additional costs to be borne by the buyer, while for SaaS applications these costs are typically included in the license price.

Hardware

These costs are placed on the purchaser for on-premises applications while for SaaS solutions, the hardware (e.g. server) is provided by the vendor as part of the cloud infrastructure. With the hardware costs, provisioning, floor / rack space and maintenance provided by the SaaS supplier, the customer saves on capital costs, utilities and other expenses. Additionally, cloud suppliers provide for auto-sizing when computing demands fluctuate in order to ensure optimal performance.

System Management

While the customer is responsible for managing on-premise systems (hardware and software maintenance and updates, security management), these activities and associated personnel costs are included in SaaS offerings.

Deployment

Deployment of cloud-based systems is provided by the SaaS suppliers, while it is often a customer responsibility for on-premises systems. For locally installed systems, this involves time-consuming and expensive installation and configuration of servers, virtual machines, databases, network architecture, network security, disaster recovery and business continuity, all of which require a number of different IT specialists. The process from planning stage to actual deployment can take from weeks to months depending on the need.

Availability

Today’s cloud environments provide redundant computing architectures that provide the ability to replace a computing environment (OS, application, database) almost instantaneously. These cloud data centers have multiple sources of power, internet access, etc. and can even replicate systems across multiple geographies to reduce the potential impact of regional events.

Asset Retirement

SaaS solutions eliminate the need and costs for removing the software, and for repurposing (or disposal) of hardware assets. SaaS solutions also typically provide a method for downloading data from that environment so that data retention requirements can be met.

KEY TCO CONSIDERATIONS FOR LIFE SCIENCE

There are other components that impact TCO in Life Science that are not simple to calculate. Some of these include:

Data Sharing

In many Life Science environments, manufacturing is split across multiple internal teams across different locations and throughout the external development and production supply chain. Data can also be generated outside the traditional manufacturing environment (e.g. patient data for cell and gene therapy products). Most SaaS solutions allow for a “single source of truth” providing access by users from multiple organizations to the same software and selected data. This eliminates the concern of providing external users access to the customer’s internal network that may be required with on-premise solutions.

Security

Large cloud environment suppliers such as AWS invest heavily in security and monitoring tools – and typically have a greater number of highly skilled security specialists than most companies can afford in their data centers.

Validation

Studies have shown that validation can add 40% to the cost of software implementation (Accenture, 2000). SaaS solutions help manage these costs by eliminating (or reducing) the costs for Installation Qualification as the installation is performed by the SaaS supplier in their cloud environment.

Scalability

Adopting SaaS software that remains valuable regardless of your existing IT landscape – helps avoid redundancy and portfolio inefficiencies. As products move from early to later phases and usage grows, new hardware and software may be required; addressing these growth needs has been automated in modern cloud-based architectures through auto-scaling technology.

SKYLAND PIMS IS PURPOSE-BUILT TO PROVIDE A FULL LIFECYCLE TOC ADVANTAGE WHILE MEETING THE STRICT NEEDS OF LIFE SCIENCE MANUFACTURING.

Skyland PIMS Data Collaboration Portal

  • Create and manage process definitions
  • Establish transparency into status of all batches
  • Manage specification and target control limits
  • Generate charts and reports
  • 100% cloud-based – promotes data sharing, visibility and integrity; lower TCO
  • Simplified licensing – by drug product/family with unlimited users, seats and data views
  • Rapid Deployment – ready for product and process data entry and uploads in just a few hours
  • Validatable – save up to 80% time; Part 11 compliant
  • Scalable – supports evolving data and analytics landscape
  • Secure – dedicated database and software instance; dedicated instances

SKYLAND PIMS® SAAS SOLUTION

Skyland PIMS data collaboration platform was purpose-built with the unique needs of Life Science manufacturers in mind. Studies performed for Skyland PIMS customers show a TCO savings of up to 72% compared to comparable on-premises solutions. In addition to providing an extremely competitive full lifecycle TCO, Skyland PIMS has the following advantages:

21 CFR Part 11

PIMS is fully compliant for Part 11 environments.

Implementation

PIMS is designed for rapid deployment (in hours) and easy implementation (no programming required). The system can be set up by users in a day after deployment, and implementations for a single product can typically be performed by users within a few days. This compares to other data analytics solutions that can take months, and significant data modeling skills, to implement for a single product, with each product implementation often costing as much as the initial software license.

Security

Each customer’s environment is a dedicated database and software instance (single tenant) on the AWS platform so data from multiple customers is not co-mingled. AWS provides robust security model that envelopes the provided virtual private cloud; the software is authenticated with a customer’s own industry standard LDAP or SAML identity and access management system. Additionally, Skyland PIMS provides for secure data transport along with VPN tunneling when needed for secure access to data sources.

Validation

Skyland focuses on reducing the time and costs for customer validation (for those who choose to validate).

  • Customers realize up to 80%-time savings using Skyland’s Validation Kit. This kit supports customer OQ validation efforts, specifically addressing the areas of software requirements, test documents, and traceability matrix linking the requirements to tests.
  • Skyland leaves timing of installation of new releases to the customer and performs updates only after the customer approves the installation – thus preserving the validity of the validated environment.
  • Skyland provides for multiple, dedicated instances in a single Virtual Private Cloud (VPC) to support a typical deployment lifecycle (e.g. Development, Test and Production instances).
  • Skyland can provide an Installation Verification report after creation of each new PIMS instance to support IQ documentation.

Skyland Analytics helps life science manufacturers streamline drug product, process and patient data management by offering cloud-based software solutions that ensure Part 11-compliant data visibility and integrity throughout the product lifecycle and across the supply chain.

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