Regulated industries—such as pharmaceuticals and biotechnology—confront a unique set of challenges: meet the requirements set forth by regulating agencies or face severe consequences—including fines, plant closings, and lost revenue.
Due to the flexible and modular nature of Datastream 7i, companies can combine build a life science asset management solution that meets regulatory requirements, increases efficiency, and grows the bottom line. Through a single, comprehensive solution, companies can:
- Track, manage, maintain, and extend the life of critical assets
- Comply with 21 CFR 11 regulations and ISO standards
- Improve operational productivity and processes
- Increase both equipment and staff productivity
Audit Trails
FDA requires that pharmaceutical companies provide them with accurate documentation regarding their practices, systems, and equipment. Pharmaceutical asset management at that level of detail takes countless man-hours due to poor record keeping and error-prone manual processes. Companies resolve this problem using Datastream 7i to:
- Provide auditing tools to guarantee quality and safety
- Track selected entries, changes, and deletions
- Compiling complete records with snapshots of all related functions
Calibration Software
Calibration of the equipment, instruments, and processes used in manufacturing is essential in achieving the high-level of precision required by regulatory agencies like the Food and Drug Administration (FDA) and the International Organization for Standardization (ISO). With the Calibration module, customers can use software to:
- Test and verify instrument accuracy against a known standard for compliance with ISO 9000, FDA, JCAHO, and other regulations
- Integrate calibration data with other business areas
- Distinguish between instruments and their positions/tags to allow the tracking of replacements
- Track calibration costs
- Access the system remotely through mobile capabilities, replace paper log books
Document Control
Document control focuses on controlling distribution rights and access to change or revise documentation for protocols and procedures. Datastream 7i allows administrators to specify multiple staff members who must approve changes to procedures such as calibrations or inspection tasks. In addition, the Datastream 7i screening and approval process records all document submissions, reviews, and approvals or rejections. This provides further safeguards for sensitive documents.
Electronic Signatures
Companies that use electronic signatures must ensure their uniqueness, security, and validity. An advanced 21 CFR 11 Datastream 7i module implements electronic signatures through a pop-up screen whenever an action, such as a work or purchase order acceptance or rejection, requires a signature.
As mandated by 21 CFR 11, the popup screen requires a user name, password, and signature meaning (i.e., rejection, approval, authorship, etc.). An individual company can create signature meanings tailored to their operations in addition to the standard meanings included with Datastream 7i. These signature procedures enable companies to track who altered a document and show when it was altered, giving FDA inspectors a clear audit trail.
- Includes an automatic pop-up based on customer set-up criteria
- Requires User ID, Password, Signature Type
- Allows sequential signing (after first full signature) using only Password
PM Revision Control
Datastream 7i includes built-in preventive maintenance revision control features to help ensure document integrity, which is an important requirement in achieving 21 CFR 11 compliance. This allows users to protect and preserve documented maintenance procedures, such as job instructions, material needs, the frequency of tasks, inspection routes, routines, and preventive maintenance requirements. If a change to an existing document is requested, the user must create a new version of the document, which is then routed to a pre-defined group of supervisors who electronically sign off on the new procedures before activation.
Record & Data Availability
Datastream 7i gives companies the ability to print and export records in various formats, including Microsoft® Excel spreadsheets and Adobe® Acrobat® PDF files. In addition, Datastream 7i is one of the only asset management software products that allow companies to compile a record library that follows progressive changes. This gives companies and FDA inspectors accurate documentation of each alteration in the system.
Security
While most systems provide password protection, Datastream 7i meets or exceeds the 21 CFR 11 regulations dealing with authorized use and system access. With Datastream 7i, administrators can set parameters to ensure password and ID integrity. One parameter allows them to indicate the maximum number of days a user can keep a password before requiring a new password. Datastream7i remembers all passwords, and administrators can specify a certain period during which a user cannot reuse passwords. These features ensure optimal protection levels against malicious attacks on the system and prevent record tampering.
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Time & Cost Savings
Regulated industries will recognize time savings from the increased efficiency that comes with Datastream 7i asset management, which translates into cost savings. But the real savings comes from ensuring compliancy with the regulations set forth by the FDA and other agencies. Failure to meet these regulations can delay getting products to market and result in regulatory fines, plant closings, and lost revenue.
Validation
All pharmaceutical companies need to validate technology-based systems to prove that the system operates as designed and configured before they can be deployed. Leading pharmaceutical companies around the world have validated Datastream software due to its unparalleled security, stability, and configurability. And Datastream has developed a strong partner network of validation experts who are available to help customers during the validation process.
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