Pharmaceutical Operations

Responding to the challenges of distributed, global manufacturing is critical to the continued growth of life sciences organizations. Many organizations require the flexibility to manufacture their products when they want (24 hours per day), where they want (worldwide), and to whom they want (global markets).

To accomplish this, these organizations need to efficiently manage their regulated and controlled operations content that fuel their global manufacturing machines.

Life sciences organisations are also facing increasingly stringent regulatory requirements for their operations processes in the manufacturing and quality areas.

In response to these industry pressures, DCS’s information management solutions automate the creation and maintenance of operations documentation and records (such as SOPs and quality documents) in compliance with the rigorous policies that govern the life sciences industry. Operations documentation that needs to be compliant includes the local prescribed regulatory requirements for electronic records and signatures as well as the record-keeping required for compliance with good quality practices and good manufacturing practices.

Key requirements for operations content management include:

Create, distribute, and monitor manufacturing content – If you are an operations, quality, manufacturing, or plant executive, you need to assure that all content is managed efficiently within regulatory guidelines since failure to do so will result in citations, interruption in new product approval, and possibly seizure and/or complete shutdown of manufacturing facilities.

Review and approve labels and art work – To speed products to market, the process of creating, reviewing, and approving labels and accompanying art work must be efficient. Also, content management systems must support internal- as well as external-based workflows as creation of this material may involve outside agencies (such as marketing, advertising, and printing).

Oversee and improve product quality – Maintaining adequate, detailed, and validated records is the cornerstone of GMP and covers every aspect of a product’s lifecycle (such as specifications, batch manufacturing, package records, and quality control information). However, manual methods of maintaining this information are costly while regulatory compliance is almost impossible with paper-based systems due to the increased complexity of manufacturing processes and stringent regulatory guidelines.

Track and manage corrective and preventive actions – Quality assurance, quality control, regulatory affairs, and manufacturing personnel need to have an efficient way to log and track deviations, nonconformances, and investigations as well as customer complaints, audit observations, change requests, and any resulting corrective and preventive actions. Manual, paper-based methods of managing this information are slow, inefficient, and pose a regulatory risk.

Solutions which address the above requirements:

FileStore document and content management
FileStore is a suite of document and content management products which enable your organisation to create, manage, approve, review a coordinated set of operations documentation and SOPs.

Full auditing, lifecycle management and team workflow business processes can be implemented to comply with existing submission procedures and SOPs.

Alchemy document archiving solution
Alchemy is a low cost and easy to use solution for the bulk archive of any electronic or scanned information such as CRFs, SOPs, Research notes, etc.

Kofax Capture
Kofax Capture, formerly Ascent Capture, collects documents and forms, transforming them into accurate, retrievable information, and delivering it all into your business applications and databases thus speeding up your business processes.

Document scanning services
DCS provide a full outsource service (on or off-site) to securely handle the scanning and digital production of operations and production paperwork. Our scanners can handle anything from operations batch processing forms capture to old microfilm archive records all integrated into a single accessible information resource.

If you would like to arrange an instant web demonstration NOW with one of our consultants then please contact DCS